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Archives of Physical Medicine and Rehabilitation

○ Elsevier BV

Preprints posted in the last 90 days, ranked by how well they match Archives of Physical Medicine and Rehabilitation's content profile, based on 10 papers previously published here. The average preprint has a 0.02% match score for this journal, so anything above that is already an above-average fit.

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Determining the optimal volume of reactive balance training after stroke: a pilot randomized controlled trial

Mansfield, A.; Jagroop, D.; Danells, C. J.; Bhatt, T.; Inness, E. L.

2026-09-07 rehabilitation medicine and physical therapy 10.64898/2026.09.02.26362056 medRxiv
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Background: Our long-term goal is to determine the optimal volume of reactive balance training (RBT) in people with sub-acute stroke. This study aims to inform the design of a larger trial to address this long-term goal. Trial design: Assessor-blinded three-arm pilot randomized controlled trial. Methods: Participants (n=36) with sub-acute stroke were randomly allocated to one of three groups: 1, 3, or 6 RBT sessions. All sessions were delivered over 2-3 weeks. Feasibility outcomes included recruitment and retention rates, intervention fidelity and adherence, and completeness of outcome assessments. Participants reported falls and physical activity for 6 months post-training; falls data were used to estimate sample size for a future trial. Functional balance, balance confidence, and balance reactions were assessed at: 1) study enrolment; 2) post-training; and 3) 6 months post-training to estimate effect sizes for a future trial. Results: Thirty-five participants initiated training and 34 contributed post-training assessment data. Intervention adherence was high: participants completed 1.0, 2.9, and 5.7 RBT sessions on average in the 1-, 3- and 6-session, respectively. Functional and questionnaire outcomes were [≥]80% complete at most time points, although follow-up questionnaires at 2 and 4 months met only 74% completeness. Falls monitoring data were available for 30 participants, with 15 falls reported. Estimated sample sizes for a definitive trial using falls as the primary outcome (n=408-782) were not feasible for a single site; alternative primary outcomes (stability following balance perturbations) produced more feasible sample size estimates (n=30-72). Minor adverse events were reported by 1, 2, and 6 participants in the 1-, 3- and 6-session groups, respectively. Conclusions: The modified intervention and assessment procedures were feasible; however, a definitive single-site trial using falls as the primary outcome is not feasible. Stability-based outcomes may support a more feasible future trial. Trial registration: clinicaltrials.gov, NCT04219696

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Comparative effectiveness of digital health interventions for low back pain: systematic review and network meta-analysis of randomised controlled trials

Chen, R.; Wu, Z.; Wei, X.; Yang, W.; Yan, C.; Chen, H.; Zeng, X.; Ding, K.; Xu, X.; Zhu, X.; Zhang, J.; Zeng, X.; Guan, X.; Cai, X.; Huang, C.; Niu, Z.; Zhang, S.; Xu, T.; Xiao, H.; Liu, J.; Guo, C.; Zhu, T.; Song, J.; Alzahrani, H.; Fatoye, F.; Ma, D.; Chen, C.

2026-09-25 rehabilitation medicine and physical therapy 10.64898/2026.09.23.26363780 medRxiv
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Objective To determine the comparative effectiveness of different digital health interventions for adults with low back pain. Design Systematic review and network meta-analysis of randomised controlled trials. Data sources PubMed, Embase, the Cochrane Central Register of Controlled Trials (CENTRAL), CINAHL, APA PsycINFO, ClinicalTrials.gov, and the World Health Organization International Clinical Trials Registry Platform (WHO ICTRP), from inception to 19 March 2026 (updated to 8 August 2026). Study selection Randomised controlled trials enrolling adults with low back pain. Interventions were classified as telemedicine, web-based applications (Web-App), mobile applications (Mobile-App), virtual reality (VR), exergaming, biofeedback devices, face-to-face care, and control. Paired reviewers independently screened records, extracted data, and assessed risk of bias using the Cochrane Risk of Bias 2 tool. Methods Frequentist random-effects network meta-analyses synthesised pain intensity and physical function (primary outcomes), and pain-related fear avoidance, health-related quality of life, self-efficacy, anxiety, and depression (secondary outcomes), assessed at post-intervention (from the end of treatment to < 2 months post-intervention), short-term ([&ge;]2 to <6 months), mid-term ([&ge;]6 to <12 months), and long-term ([&ge;]12 months) follow-up. Effects were reported as standardised mean differences with 95% confidence intervals. Transitivity was examined across potential effect modifiers, and Confidence in Network Meta-Analysis (CINeMA) informed confidence ratings. Results Ninety-two reports representing 84 trials involving 11 649 participants were included. At post-intervention, compared with control, VR showed the largest estimated reduction in pain intensity (SMD -1.43, 95% CI -1.87 to -0.98; moderate confidence) and improvement in physical function (-0.86, -1.45 to -0.26; very low confidence). VR was also associated with lower pain-related fear avoidance (-1.14, -1.68 to -0.61) and better health-related quality of life (0.97, 0.57 to 1.36) (both moderate confidence). Exergaming, Mobile-App, Web-App and telemedicine were also associated with lower pain intensity, while Mobile-App, Web-App, telemedicine, and biofeedback devices were associated with better physical function. For self-efficacy, exergaming (0.77, 0.05 to 1.49) showed favourable post-intervention effects, although confidence in this estimate was very low. No intervention showed a clear effect on anxiety, with confidence ranging from very low to moderate across comparisons, whereas telemedicine was associated with lower depression (-0.22, -0.44 to 0.00; low confidence). Networks became progressively sparse at later follow-up, and evidence of sustained effects was inconsistent across interventions and outcomes. Global inconsistency was detected in the post-intervention pain-intensity network, with local inconsistency identified for selected exergaming comparisons, and substantial heterogeneity was present in several networks. Conclusions Among adults with low back pain, VR showed the largest estimated post-intervention effects versus control for pain intensity, physical function, pain-related fear avoidance, and health-related quality of life, although comparative effects differed across outcomes. Self-efficacy showed favourable estimates for selected interventions, whereas evidence for anxiety and depression was limited. Evidence beyond treatment completion was increasingly sparse, and confidence in many network estimates was low or very low; firm comparative recommendations therefore remain premature. Systematic review registration PROSPERO CRD420261339841

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The Effects of a Digital Exercise Therapy Application for Patients with Shoulder and Knee Pain During the COVID-19 Pandemic

McLaughlin, K. H.; Gruner, M.; Ahmadian, N.; Patch, T.; Zakria, B.; Skolasky, R. L.

2026-10-01 rehabilitation medicine and physical therapy 10.64898/2026.09.25.26364013 medRxiv
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Objective: To examine changes in function and pain interference among patients utilizing a digital exercise therapy application (DETA) for knee and shoulder pain. Methods: We conducted a retrospective analysis of data from patients utilizing a DETA for non-operative knee and shoulder pain. Primary outcomes for the study were 8-week changes in physical function, measured using the PROMIS-Physical Function (knee pain) and PROMIS-Upper Extremity Function (shoulder pain); and pain interference, measured using the PROMIS-Pain Interference. Data on patient characteristics was used to examine outcomes among specific patient subgroups. Results: We observed a 3.5 point (SD: 7.8) increase in function and a 3.9 point (SD: 7.5) decrease in pain interference overall (p<0.001), with changes in function and pain interference surpassing the minimal clinically important difference for patients with knee and shoulder pain. Patients with knee pain experienced greater improvements in function than those with shoulder pain (p=0.02), as did patients who report moderate-high levels of exertion during exercise compared to those reporting low levels of exertion (p=0.05). We saw greater reductions in pain interference among those with higher education (p=0.03), those with more acute symptoms (p=0.01) and those reporting moderate-high levels of exercise exertion (p=0.02). Conclusion: We observed a clinically meaningful improvement in pain interference and function among patients utilizing a DETA for knee and shoulder pain. Patients with knee pain, higher levels of education, more acute symptoms, and those who reported higher levels of exertion with exercise experienced the greatest changes in function and pain. Impact Statement: This study indicates that self-guided interventions, such as those delivered through a DETA, may be beneficial for patients with knee and shoulder pain. These results may also inform the development of patient profiles that can be used to identify patients most appropriate to receive care through a mobile application.

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Patient factors influencing participation in aerobic exercise during inpatient and outpatient rehabilitation post stroke: a prospective cohort study

Barzideh, A.; Devasahayam, A. J.; Marzolini, S.; Munce, S.; Sibley, K. M.; Inness, E. L.; Mansfield, A.

2026-08-31 rehabilitation medicine and physical therapy 10.64898/2026.08.26.26361451 medRxiv
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Background: Aerobic exercise is recommended during stroke rehabilitation to improve cardiorespiratory fitness and support recovery; however, participation rates remain low. While institutional and system-level barriers have been widely examined, less is known about how individual patient factors influence engagement in aerobic exercise during rehabilitation. Objectives: We aimed to determine whether depressive symptoms, apathy, self-efficacy and outcome expectations for exercise, perceived barriers, or past exercise history were associated with aerobic exercise participation in stroke rehabilitation. Methods: In this prospective cohort sub-study, adults admitted to in- or out-patient stroke rehabilitation at three urban hospitals completed validated questionnaires assessing depressive symptoms, apathy, exercise self-efficacy, outcome expectations for exercise, perceived barriers to being active, and premorbid exercise history. Participants were separated into two groups for analysis: those who completed aerobic exercise during rehabilitation and those who did not. Equivalence testing and between-group comparisons were performed. Results: Sixty-two participants were enrolled; 16 participated in aerobic exercise and 46 did not. Groups were not equivalent on any individual-level factors. Compared to non-participants, those who performed aerobic exercise had significantly higher depressive symptom scores (p=0.0025) and lower self-efficacy for exercise (p=0.0087). Non-participants demonstrated significantly higher apathy (p=0.0007). No significant differences were found for outcome expectations, perceived barriers, or exercise history. Conclusion: Depressive symptoms and lower self-efficacy did not impede aerobic exercise participation during rehabilitation. Increased apathy, however, was associated with non-participation. Findings highlight the need for individually tailored aerobic exercise prescriptions that consider motivational and affective factors to optimize engagement during stroke rehabilitation.

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Prehabilitative Exercise Mitigates Immobilization-Induced Atrophy Through Muscle Reserve Rather Than Resistance to Disuse: The PRE-EX Randomized Controlled Trial

Soendenbroe, C.; Pedersen, S. D.; Pulevic, L.; El Khoury, A.; Christiansen, H. L.; Linden, F. H.; Magnusson, S. P.; Svensson, R. B.; Schjerling, P.; Kjaer, M.; Mackey, A. L.

2026-09-27 rehabilitation medicine and physical therapy 10.64898/2026.09.25.26363998 medRxiv
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Periods of limb immobilization are common in clinical care and lead to rapid losses of muscle mass and strength. We therefore examined whether prehabilitative exercise improves outcomes after disuse by increasing pre-immobilization muscle reserve or by attenuating the biological response to immobilization. Here, we report the primary and muscle-focused secondary outcomes of the PRE-EX (PREhabilitative EXercise) randomized controlled trial (ClinicalTrials.gov: NCT06205784). Fifty-four healthy younger and older women completed four weeks of supervised resistance exercise or no training before eight days of unilateral limb immobilization, followed by four weeks of rehabilitation. From baseline to pre-immobilization, prehabilitation increased quadriceps cross-sectional area (CSA) by 6.7%, maximal voluntary contraction (MVC) by 15.2%, and muscle fiber CSA by 17.7%. Immobilization subsequently reduced quadriceps CSA by 3.2% over 5 days and MVC by ~20%, with similar relative losses in the Prehab and No-train groups. Consequently, quadriceps CSA, the studys primary outcome, remained greater in Prehab than in No-train after immobilization and following rehabilitation, while MVC was greater following rehabilitation. Prehabilitation did not preserve markers of neuromuscular innervation or produce a detectable post-immobilization transcriptomic signature. Instead, immobilization elicited an extensive transcriptional response comprising more than 7000 differentially expressed genes, characterized by activation of inflammatory, proteolytic, stress, and denervation-associated programs together with suppression of mitochondrial and muscle-structural pathways. Network analysis further linked these coordinated molecular programs to disuse-related changes in muscle size, strength, and morphology. The effects of prehabilitation and the subsequent response to immobilization were similar in younger and older women. These findings demonstrate that short-term prehabilitative exercise mitigates the consequences of limb immobilization by establishing greater muscle and strength reserve before disuse, rather than by attenuating the physiological or molecular response to immobilization.

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Strengthening Cardiac Rehabilitation: Key Strategies for Enhancing Accessibility and Outcomes

Tawalbeh, R.; Ellis, J. L.; Ebersole, K. T.; Litwack, K.

2026-08-25 rehabilitation medicine and physical therapy 10.64898/2026.08.20.26360821 medRxiv
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Abstract Introduction: Cardiac rehabilitation (CR) is key for secondary prevention; however, participation remains low due to persistent barriers. Identifying strategies used by high-performing programs may inform approaches to improve patient engagement and outcomes. Purpose: To identify strategies associated with improved participation and adherence in CR programs from the perspective of leaders in high-performing sites. Methods: Semi-structured interviews were conducted with 10 CR leaders from urban, suburban, and rural programs ranked in the top 10% on at least two objective performance measures (e.g., participation and adherence rates) but moderate or low on others. Data were analyzed using thematic analysis to identify strategies associated with high performance. Results: Programs with high participation and adherence rates consistently implemented proactive, patient-centered strategies to address barriers. Individualized care approaches tailored to language, culture, health literacy, and age were commonly used to improve engagement among Hispanic, Black, and older adult populations. High-performing programs addressed structural barriers such as insurance and transportation through flexible scheduling, community partnerships, and targeted outreach. Strong coordination with referring providers and effective transitions from inpatient to outpatient care were associated with higher enrollment and sustained participation. Additional strategies included staff development through ongoing education, use of digital tools for patient tracking, and implementation of virtual and hybrid CR models. Integration of psychological support further enhanced patient engagement. Conclusion: High-performing CR programs employ coordinated, patient-centered, and system-level strategies associated with improved participation and adherence. These findings provide actionable approaches to enhance accessibility and improve programs and patients outcomes in CR across diverse settings. Keywords: Cardiac rehabilitation; participation; adherence; health disparities; implementation strategies

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Clinical and neurophysiological determinants of response to contralesional low-frequency repetitive transcranial magnetic stimulation after stroke: A systematic review and meta-analysis

Yu, M.; Zeng, Y.; Zhou, H.; Lin, J.; Hao, M.

2026-08-21 rehabilitation medicine and physical therapy 10.64898/2026.08.20.26360649 medRxiv
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Background: Low-frequency repetitive transcranial magnetic stimulation (LF-rTMS) over the contralesional primary motor cortex is widely used for post-stroke upper-limb rehabilitation, but treatment response varies substantially. This systematic review and meta-analysis aimed to quantify the efficacy of contralesional LF-rTMS and to examine whether baseline motor impairment severity and corticospinal tract (CST) integrity modify treatment effects. Methods: We searched seven databases from inception to July 2026 for randomized controlled trials of contralesional LF-rTMS ([&le;]1 Hz) versus sham after stroke, with comparable rehabilitation in both arms. The primary outcome was the change in Fugl-Meyer Assessment for the upper extremity (FMA-UE) scores. Random-effects meta-analysis used restricted maximum likelihood estimation with Knapp-Hartung adjustment. Effect modification was examined through meta-regression and biomarker-stratified analyses, and neurophysiological outcomes were also synthesized. Results: Thirty trials (33 comparisons, 1,668 participants) were included. LF-rTMS produced greater FMA-UE improvement than sham (mean difference 4.11 points, 95% CI 2.83-5.39; Hedges g 0.64, 95% CI 0.45-0.84), with substantial heterogeneity. Baseline severity did not significantly modify the effect in continuous meta-regression. However, exploratory within-trial biomarker-stratified analyses suggested larger effects in participants with preserved CST integrity or positive motor-evoked potential (MEP) status. LF-rTMS also shortened MEP latency and central motor conduction time, but these measures could not be validated as surrogate endpoints. Conclusions: Contralesional LF-rTMS provides a statistically significant but modest improvement in post-stroke upper-limb motor recovery. Baseline clinical severity alone may not identify responders, whereas CST integrity is an exploratory, hypothesis-generating candidate biomarker. It requires confirmation in adequately powered biomarker-stratified trials before it can inform clinical decisions. Trial Registration The study was registered with the International Prospective Register of Systematic Reviews (PROSPERO: CRD420261441561).

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Sensorimotor effects of heatwrap and exercise in acute low back pain: results of a randomised controlled trial

Cote Picard, C.; Desgagnes, A.; Tittley, J.; Mailloux, C.; Perreault, K.; Mercier, C.; Dionne, C. E.; Roy, J.-S.; Masse-Alarie, H.

2026-09-02 rehabilitation medicine and physical therapy 10.64898/2026.08.31.26361841 medRxiv
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Background: Heatwrap is recommended for acute low back pain (ALBP), and previous research found heatwrap plus exercise more effective than each intervention alone. While recommended by clinical guidelines, their impact on mechanistic outcomes is unknown. This trial aimed to (i) assess immediate and short-term effects of heatwrap alone or combined with exercise, compared with a sham heatwrap, on pain sensitivity, lumbar muscle activity, current pain intensity, and trunk flexion range of motion, and (ii) explore whether changes in pain sensitivity and lumbar muscle activity are associated with changes in clinical symptoms from baseline to 1-week follow-up. Methods: A randomised controlled trial took place at a single research center. Of 315 individuals screened for eligibility, 99 adults with ALBP were recruited and assigned to one of three intervention groups: heatwrap plus exercise (n=34), heatwrap alone (n=33) or sham heatwrap (n=32). Interventions were applied for one hour at the first visit, and immediate effects were measured. Then, interventions were applied for 7 days, and short-term effects were measured at 1-week follow-up. Outcomes included pressure pain threshold, temporal summation of pain, flexion-relaxation ratio, trunk range of motion and current pain intensity. Results: Heatwrap and exercise did not produce greater effects over time than heatwrap alone or a sham heatwrap on all outcomes, and changes in sensorimotor outcomes at one week were not associated with changes in symptoms. Conclusions: Heatwrap and/or exercises did not influence specifically the potential sensorimotor mechanisms tested in individuals with ALBP. Trial registration: ClinicalTrials.gov; registration number: NCT03986047

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Wearable vibrotactile stimulation shirts and gloves for upper extremity stroke rehabilitation: A pilot randomized controlled trial

Ayyad, W.; Kim, Y.; Odom, N.; Al Borno, M.

2026-07-29 rehabilitation medicine and physical therapy 10.64898/2026.07.26.26358522 medRxiv
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Objective Conduct a randomized controlled trial to investigate the safety, feasibility, and efficacy of wearable vibrotactile stimulation shirts and gloves for upper extremity stroke rehabilitation at the inpatient rehabilitation unit. The primary outcome measure was the Fugl-Meyer Assessment Upper Extremity (FMA-UE) motor score. The secondary outcome measures were the Modified Ashworth Scale (MAS) and statistics on device safety and feasibility. Exploratory outcome measures were the FMA-UE sensation, passive joint motion, and joint pain scores. Also, the MAS for the fingers, wrist, and elbow scores. Methods A total of 24 ischemic stroke patients were recruited for this study (45 to 85 years old) during their stay at the inpatient rehabilitation unit, which averaged 15.3 {+/-} 4.5 days. Patients were randomly assigned to a treatment or control group, with 12 participants in each group. The control group received conventional therapy only, while the treatment group received both conventional therapy and vibrotactile stimulation. Participants in the treatment group wore the vibrotactile stimulation gloves and shirts for 1.5 hours per day, 5 days per week. Upper extremity impairment and spasticity were assessed with the FMA-UE and MAS at both admission and discharge from the rehabilitation unit. In addition, feedback from patients in the treatment group was collected through a questionnaire to evaluate comfort, usability, and satisfaction. The trial was prospectively registered at ClinicalTrials.gov (NCT06244719). Results The vibrotactile stimulation was safe and well-tolerated by stroke patients. No statistically significant differences were noted in FMA-UE motor scores and total MAS scores between the groups; however, exploratory analyses revealed a significant improvement in FMA-UE joint pain scores in the treatment group. A trend towards reduced wrist spasticity was observed in the treatment group, but this effect did not remain significant after correcting for multiple comparisons. Responder analyses showed a greater proportion of responders in the treatment group for both FMA-UE and MAS outcomes. Conclusions Our results show promise for a larger sample size study and follow-up work with longer durations of vibrotactile stimulation with gloves and shirts for upper extremity stroke rehabilitation. Although no significant improvements were observed in FMA-UE motor function or total MAS scores, vibrotactile stimulation was associated with reduced joint pain, potential benefits for distal spastic hypertonia, and increased responder rates.

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RObotic WAlking for children who CAnnot WAlk (RoWaCaWa): Impacts on Physical Function and Physical Activity from a 12-week robotic walking intervention

Youngblood, J. L.; Diot, C. M.; Norman, B. M.; Eldred, K.; Rande, A.; Dukelow, S. P.; Alazem, H.; McCormick, A.; Longmuir, P. E.; Shen, H.; Larkin-Kaiser, K. A.; Condliffe, E. G.

2026-08-27 rehabilitation medicine and physical therapy 10.64898/2026.08.24.26361255 medRxiv
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Purpose: To explore how 12-weeks of robotic walking impacts physical function and sequelae of inactivity for individuals with pediatric-onset neuromotor impairments. Methods: A single-arm mixed-methods interventional study examined robotic walking for 12-weeks in home and community settings, with 12-week follow-up. Outcomes included family goals (Goal Attainment Scale (GAS)) and perspectives (Interviews), postural control (Early Clinical Assessment of Balance), physical activity (Actigraphy, Habitual Activity Estimation Scale, Patient Reported Outcome Measurement Information System (PROMIS) Physical Activity) and sequelae of inactivity (PROMIS Sleep Disturbances, Bowel Function Diary). GAS was collected pre-training, post-training, and 12-week follow-up. All other quantitative outcomes were collected every 4-weeks. Quantitative data are described with median (25th-75thpercentile) and analyzed using a Skillings-Mack test with post-hoc Wilcoxon Signed-Rank. Qualitative interviews were conducted before and after training and analyzed thematically. Results: 15 participants aged 4-23 completed this study. Participants had cerebral palsy (10/15) or rare genetic conditions (5/15), and most used a wheelchair in community settings. Postural control improved (test-statistic = 23.0, p<0.001) after 8 weeks (change=5.0(0.0-21.4), p=0.016) and was maintained through 12-week follow-up (change=13.7(3.1-23.7), p=0.008). Over half of the participants achieved goals (t-score > 50) after training. Exploratory analyses suggest improvements in sleep disturbance immediately after training (p=0.025) and 4-weeks after (p=0.047). All measures of physical activity did not improve. Parents reported improvements in walking, activities of daily living, and sequelae of inactivity (i.e., bowel function, appetite, and sleep). Conclusions: Improvements were seen across a range of measures and notably postural control improvements were maintained at the follow-up. Parents perceived improvements in physical function and activities of daily living. Future research is warranted to further understand the impacts of robotic walking for children and small adults with mobility impairments.

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A single-session randomised crossover fNIRS study comparing three upper-limb mirror therapy task paradigms in healthy adults: a study protocol

Yang, T.; Wei, S.; Wang, Y.; Bai, D.

2026-09-02 rehabilitation medicine and physical therapy 10.64898/2026.08.28.26361691 medRxiv
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Background Mirror therapy (MT)-specifically paradigms using mirror visual feedback (MVF)-is widely used in neurorehabilitation; however, mechanistic implementations vary substantially in movement content, rhythmicity and attentional demands. This protocol describes an acute mechanistic, within-participant fNIRS screening study designed to compare three prespecified upper-limb mirror-therapy task paradigms and to quantify associated subjective experience after each condition in healthy adults during a single visit. Methods and analysis This is a single-centre, within-participant, randomised crossover study conducted at Wuhan Wuchang Hospital (Wuhan, China). Healthy adults aged 18-35 years will complete three task conditions once each in a counterbalanced order using a 3*3 Latin-square scheme: UMT1 (task-oriented rhythmic functional movement), UMT2 (open-ended free movement with auditory control), and UMT3 (non-functional rhythmic movement). fNIRS will be acquired using the NirSmart-6000A system during a standardised block design. The primary outcome is ROI-level HbO activation quantified as GLM-derived {beta} estimates within the prespecified primary ROIs (bilateral SM1/M1 and bilateral PMC). Secondary outcomes include ROI-level windowed {Delta}HbO (5-20 s post-onset relative to the immediately preceding rest; descriptive only), ROI-level {Delta}HbR, and post-condition subjective ratings (illusion, immersion, confusion and fatigue; 1-7 Likert). Condition effects will be analysed using linear mixed-effects models with fixed effects for condition and period and prespecified multiplicity-adjusted pairwise contrasts. Ethics and dissemination Ethics approval was obtained from the Ethics Committee of Wuchang Hospital Affiliated to Wuhan University of Science and Technology (Approval No.: 2025-112-01; approved on 2025-08-21). The study is expected to be minimal risk. Findings will be disseminated through publication of this protocol manuscript and subsequent results manuscripts and conference presentations. Trial registration number Chinese Clinical Trial Registry (ChiCTR2600116634). This study is conducted as a prespecified mechanistic sub-study under the overarching registered project.

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Cardiovascular and autonomic responses to transcutaneous spinal cord stimulation combined with activity-based therapy after chronic spinal cord injury: An exploratory study from the MACHINE trial

Balthazaar, S. J. T.; Shackleton, C. L.; Williams, A. M. M.; Samejima, S.; Malik, R. N.; Hodgkiss, D. D.; Nightingale, T. E.; Sachdeva, R.; Elliott, S. L.; Berger, M. J.; Lam, T.; Krassioukov, A. V.

2026-08-14 rehabilitation medicine and physical therapy 10.64898/2026.08.11.26359978 medRxiv
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Objective: To describe cardiovascular and autonomic responses to body weight-supported treadmill training (BWSTT) combined with active or sham transcutaneous spinal cord stimulation (TSCS) in individuals with chronic, motor-complete spinal cord injury (SCI). Design and setting: Exploratory case series from randomized, sham-controlled clinical trial in a tertiary Rehabilitation Centre in Vancouver, Canada. Participants: Eight adults with chronic ([&ge;]1 year post-injury) traumatic, motor-complete (American Spinal Injury Association Impairment Scale A-B) SCI at or above T6 Interventions: Participants were randomized to 12 weeks of BWSTT plus lumbosacral TSCS or BWSTT plus sham stimulation, delivered 3 sessions/week. TSCS was delivered at T11-L1 using 30 Hz stimulation with a 10 kHz carrier frequency. Five participants completed the intervention, and four completed full cardiovascular testing (TSCS n=2; sham n=2). Outcome measures: Ambulatory blood pressure (BP) monitoring, participant-reported symptoms of AD and OH (via ADFSCI questionnaire), BP variability, orthostatic hemodynamics, echocardiography, electrocardiography (ECG)- and heart rate variability (HRV)-derived indices, and baroreflex function. Results: Among complete cases, several cardiovascular indices changed over time, including reduced daytime hypotensive burden in TSCS participants, preserved nocturnal dipping, and small changes in stroke volume and ECG-derived variability indices; however, responses were heterogeneous and overlapped with Sham. Both TSCS and Sham participants showed reduced autonomic symptom scores, while low-frequency blood pressure variability responses during orthostatic stress were heterogeneous and did not indicate a pattern that was specific to a cohort. Conclusion: Although preliminary, this exploratory complete-case analysis suggests that cardiovascular responses to BWSTT with active or sham TSCS are measurable but highly individualized after chronic motor-complete SCI. Given the small sample and overlapping Sham responses, findings are exploratory and larger trials are needed to determine whether TSCS augments cardiovascular autonomic adaptations to locomotor training.

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Cardiovascular exercise mitigates inflammation in the early subacute phase of stroke recovery: a secondary analysis of a randomized controlled trial

de las Heras, B.; Rodrigues, L.; Moncion, K.; Van Roy, A.; Lotlikar, M.; michalakis, F.; Sikorska, K.; Sutoski, A.; Bon, A.; Arbour, N.; Bayley, M.; Eng, J. J.; Roig, M.

2026-09-29 rehabilitation medicine and physical therapy 10.64898/2026.09.28.26364152 medRxiv
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Background: Excessive inflammation in early phases post-ischemic stroke is associated with poor long-term outcome and increased stroke recurrence. Interventions capable of downregulating persistent states of inflammation could improve recovery and prevent secondary stroke. Cardiovascular exercise (CE) has well-established anti-inflammatory effects but its capacity to attenuate the exaggerated inflammatory response triggered by ischemic stroke is unclear. Methods: We investigated the impact of eight weeks of CE on the serum concentration of inflammatory mediators in the early subacute phase post-stroke. Seventy-one patients with firstever ischemic stroke were randomly assigned to moderate-to-vigorous CE (n=45) or standard care (SC) (n=26). Concentrations of CRP, IL-6, IL-8, IL-10, TNF- and IL-1{beta} were measured at baseline and after the interventions. Differences between groups were analyzed with linear mixed models adjusted for age and sex. Results: Compared with the CE group, the SC group showed significant increases in IL-6 ({beta}=0.585, 95% CI=0.164-1.006, p=0.0073), IL-8 ({beta}=0.160, 95% CI=0.004-0.317, p=0.0447), and TNF- ({beta}=0.0845, 95% CI=0.0137-0.1553, p=0.0206). The SC group also showed greater increases in CRP ({beta}=0.250, 95% CI=-0.407, 0.906, p=0.4499) and IL-10 ({beta}=0.251, 95% CI=-0.024, 0.527, p=0.0729) but group differences were not significant. IL-1{beta} levels remained stable and differences between groups were not significant ({beta}=-0.008, 95% CI=-0.058, 0.042, p=0.7618). Conclusions: When introduced in the early subacute phase of stroke recovery, moderate-tovigorous CE mitigates increases in inflammation, but the effect differs across mediators. To what extent reducing the inflammatory response in the early stages post-stroke with CE can impact longterm recovery and stroke recurrence needs to be determined.

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Study Protocol for a Randomized Controlled Trial Comparing Swiss Ball Balance Training and Conventional Balance Training to Improve Trunk Control and Mobility in Individuals with Sub acute Stroke.

Nkhoma, B.; Mapulanga, M.

2026-09-14 rehabilitation medicine and physical therapy 10.64898/2026.09.11.26362878 medRxiv
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Stroke is a leading cause of mortality and long-term disability worldwide, with low- and middle-income countries carrying the greatest burden. Impaired trunk control and balance are common after stroke, severely limiting mobility and independence and increasing the risk of falls. Conventional balance training is widely used to improve stability, but it primarily targets static postural control and may not sufficiently activate trunk muscles during dynamic tasks. Swiss ball balance training, which uses an unstable surface to engage core musculature and enhance sensorimotor integration, has shown promising results in improving trunk control and functional mobility. However, research comparing Swiss ball balance training with conventional balance training is limited, particularly in Sub-Saharan Africa. This study aims to compare the effects of Swiss ball training and conventional balance training on trunk control, balance, and mobility in individuals with subacute stroke. A randomized, assessor-blinded, two-period, two-sequence crossover trial will be conducted. Participants will be randomly assigned to Swiss Ball Balance Training or Conventional Balance Training, each administered for 45 minutes per session, three days per week, over six weeks, with a one-week washout period between phases. Standardized clinical outcome measures will assess trunk control, postural stability, and functional mobility at baseline and after each intervention phase. Data will be analyzed using paired t-tests and Wilcoxon rank-sum tests in Stata v17 (p < 0.05). It is expected that Swiss ball exercises will yield greater improvements in trunk control, balance performance, and functional mobility than conventional methods. The results are expected to help design context-specific rehabilitation programs.

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Sarcopenia Assessment in Resource-Constrained Settings: Expert Agreement on Surrogate Measures

Prabhu, M. S.; Kolekar, S. V.; Bruyere, O.; Merchant, R. A.; Kalra, S.; Gore, S.; Agarwal, N.; Girish, N.

2026-09-10 rehabilitation medicine and physical therapy 10.64898/2026.09.06.26361926 medRxiv
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Purpose Sarcopenia, the progressive loss of muscle mass and function with age, is diagnosed by assessing muscle strength, physical performance, and muscle mass. However, the tools required are often costly, inaccessible, or unsuitable for use in low-resource or remote settings. This study aimed to identify practical surrogate measures that are conceptually aligned with established sarcopenia diagnostic criteria and can be integrated into digital health platforms to enable remote screening and monitoring using an expert agreement process. Methods A narrative literature review was conducted to identify proxy measures for muscle strength (HGS), physical performance, and muscle mass. This was followed by two rounds of expert agreement. The Content Validity Index (CVI), defined as the number of experts in agreement divided by the total number of experts for each pragmatic proxy, was calculated after each round to assess the relevance and appropriateness of each measure. A pragmatic proxy with a CVI of 0.7 or higher was included. Results Eight proxies for HGS were identified across ten studies, with the five-times sit-to-stand test (5STS) being the most common. The 5STS has a higher agreement and was considered a relevant and appropriate surrogate by the expert panel for both muscle strength (CVI = 0.8 for both relevance and appropriateness) and physical performance (CVI = 1 for relevance and 0.8 for appropriateness), whereas the TUG could be a promising measure for physical performance (CVI = 1 for both relevance and appropriateness). Calf circumference (CC) offers a low-cost alternative for assessing muscle mass (CVI = 1 for relevance and 0.7 for appropriateness). Conclusion The 5STS, TUG, and CC were identified as relevant and appropriate pragmatic proxy measures for assessing sarcopenia, with potential for integration into digital screening tools in low-resource settings. Further clinical studies are required to establish their validity, reliability, and feasibility for remote assessment.

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A Valid and Reliable Virtual Reality Tool for Assessment of Arm Nonuse Post-Stroke

Gangwani, R.; Zodrow, S.; DeAngelis, A.; Karrenbach, M.; Kantak, S.; Buxbaum, L. J.

2026-09-06 rehabilitation medicine and physical therapy 10.64898/2026.09.02.26361445 medRxiv
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Introduction: Approximately 40-80% of individuals post-stroke fail to use their paretic arm despite sufficient capacity, a phenomenon known as arm nonuse. This behavior arises from an interaction between cognitive and motor factors, necessitating evaluation approaches that capture the impact of complex task demands on arm nonuse. However, existing measures require specialized equipment, extensive setup, or prolonged monitoring, limiting their clinical feasibility. To address this gap, this study evaluated the reliability, validity, and usability of a novel virtual reality-based arm nonuse (VR-NonUse) tool designed to measure arm nonuse during naturalistic reaching under varying cognitive and motor demands. Methods: Fifty-one individuals with stroke and 23 controls completed the VR-NonUse assessment across three conditions varying in cognitive and motor demand. Usability and tolerability were evaluated. Concurrent validity was examined by assessing associations between paretic arm nonuse on the VR-NonUse tool and established nonuse assessments. Discriminant validity was evaluated by comparing these associations with a motor impairment measure. Construct validity was examined by determining the effects of cognitive and motor demand on arm use. Results: The VR-NonUse tool was usable and well-tolerated. Paretic arm nonuse on the VR-NonUse tool was associated with established nonuse measures, and more strongly related to nonuse than to motor impairment, supporting concurrent and discriminant validity. Higher cognitive demand reduced paretic arm use, supporting construct validity. A brief cognitively demanding condition yielded a robust index of nonuse. Discussion: The VR-NonUse tool is a reliable, valid, and practical assessment of arm nonuse in chronic stroke.

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Supportive Strides: Co-designing Community-Based Walking Programs with Embedded Socialisation and Peer Support for People after Stroke

Fini, N.; Cahill, P.; Beh, B. A.; Suttie, L.; Gallant, D.; Martel, A.; Mateo-Babiano, I.; Marck, C. H.; Hayward, K. S.; Ramage, E.

2026-09-20 rehabilitation medicine and physical therapy 10.64898/2026.09.17.26362966 medRxiv
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Purpose: To co-design a community-based walking program that incorporates social connection to improve physical activity post-stroke. Methods: A four-stage Integrated Knowledge Translation approach was used. Stage 1: research team (2 stroke survivors, 8 professionals) defined research questions, scope and plan. Stage 2: workshops held with stroke survivors, carers, and health and design professionals to identify important program principles. Stage 3: research team used a Nominal Group Technique to make key decisions and develop the program. Stage 4: program presented to participants; feedback gathered and adaptations made. Workshop findings were iteratively analysed and summarised during sessions. Results: Twenty-six participants were recruited across stages 2 and 4 (12 stroke survivors, 2 carers, 12 professionals). Key program principles identified in Stage 2 were social support, inclusive environment, motivational support, co-ordination and administrative support. The Supportive Strides program was co-designed to incorporate these principles. Program elements included accessible outdoor walking routes, pre-walk coffee and social connection, peer-support, online group chat, milestone celebrations, and a safety checklist. Following Stage 4 participant feedback, adaptations were incorporated e.g., simpler screening process, include more walking route information. Conclusions: The co-designed Supportive Strides community-based walking program is ready for testing to improve physical activity and social connection after stroke.

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More Than Just Arm Movement: Finger-Worn Accelerometers Provide a Valid and Sensitive Alternative to Wrist-Worn Accelerometers for Measuring Real-World Upper-Limb Performance in Stroke Survivors

Dhamrongsirivadh, R.; Pugliese, B. L.; Civeriati, V.; Piela, K.; Fabara, E.; Vergara-Diaz, G.; Wang, Q. M.; Bonato, P.; Lee, S. I.

2026-08-17 rehabilitation medicine and physical therapy 10.64898/2026.08.13.26360286 medRxiv
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Objective: To investigate the clinical validity of finger-worn accelerometers for providing a comprehensive assessment of upper-limb motor performance in stroke survivors in real-world environments, compared to wrist-worn accelerometers, and to examine how the clinimetric properties of wearable-based motor performance measures vary with the duration of patient data collection. Design: Cross-sectional observational design. Setting: Research laboratory and free-living environments. Participants: Twenty-seven stroke survivors aged 18-80 years with ischemic or hemorrhagic stroke at least six months prior to enrollment and mild-to-moderate upper-limb impairment without severe range-of-motion restrictions were enrolled. Three participants were ineligible and four withdrew, resulting in a final cohort of 20 participants (N = 20). Interventions: Not applicable. Main Outcome Measures: Wearable-based motor performance measures derived from fine-hand movements, gross-arm movements, and the combination of fine-hand and gross-arm movements captured by finger-worn and wrist-worn accelerometers in naturalistic settings for 6.4 {+/-} 1.8 days. Results: Wearable-based motor performance measures from fine-hand movements demonstrated the strongest convergent validity, known-group validity, and test-retest reliability, followed by those from combined and gross-arm movements. Convergent validity and test-retest reliability of wearable-based motor performance measures improved with longer monitoring durations, with four days being sufficient to obtain accurate and reliable upper-limb measures. Conclusions: Wearable-based motor performance measures from finger-worn accelerometers provide a more comprehensive assessment of upper-limb motor performance than those from wrist-worn accelerometers, supporting their use for real-world monitoring in stroke survivors. Furthermore, the improvements in clinimetric properties of wearable-based motor performance measures with longer monitoring durations highlight the importance of multi-day monitoring to mitigate day-to-day variability and ensure robust assessment.

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Beyond Walking Speed: Estimating and Classifying Post-Stroke Gait Propulsion From Standardized Clinical Measures

Fei, J.; Wang, R.; Awad, L.

2026-10-02 rehabilitation medicine and physical therapy 10.64898/2026.09.30.26364361 medRxiv
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Background: Gait propulsion (anterior ground reaction force) is commonly impaired after stroke. Force plates and wearable sensors can quantify propulsion but are not routinely available in clinical settings. Walking speed alone does not adequately capture the heterogeneity of propulsion deficits. Objective: To determine whether standardized clinical measures can estimate post-stroke propulsion metrics and classify propulsion impairment. Methods: Forty individuals post-stroke participated: 33 for model development and cross-validation (11 with repeated observations for longitudinal validation) and 7 for independent-cohort validation. Clinical measures included the 6-Minute Walk Test (6MWT), comfortable walking speed (CWS), Functional Gait Assessment (FGA), Fugl-Meyer Assessment of the Lower Extremity (FMA-LE), Short Physical Performance Battery (SPPB), Timed Up and Go test (TUG), and stroke chronicity. Regression models were developed to estimate three propulsion metrics: paretic propulsion peak and impulse, and interlimb propulsion symmetry. Model performance was evaluated using R2 and RMSE. Propulsion impairment was classified from symmetry estimates using a prespecified cutoff of 31.5%, with classification accuracy reported. Results: Models using the 6MWT, SPPB, TUG, and chronicity estimated paretic propulsion peak (R2 = 0.77, RMSE = 3.00 %body weight) and impulse (R2 = 0.81, RMSE = 0.65 %body weight {middle dot} %stance phase). FMA-LE, SPPB, TUG, and chronicity estimated propulsion symmetry (R2 = 0.75, RMSE = 8.56%) and classified propulsion impairment with 84.8% accuracy. Classification accuracy was 91.7% in longitudinal validation and 85.7% in independent-cohort validation. Conclusions: A multidomain clinical assessment framework may support practical and accurate estimation and classification of post-stroke propulsion impairment in clinical settings where specialized instrumentation is unavailable.

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Feasibility and Measurement Properties of a Large Language Model-Based Virtual Patient Laboratory for Clinical Reasoning Training in Physical Therapy Students: Single-Arm Pilot Study

Lerin-Calvo, A.; Perez-Gonzalez, A.; Sagarribay Villano, A.; Di-Bonaventura, S.; Ferrer-Pena, R.

2026-10-14 rehabilitation medicine and physical therapy 10.64898/2026.10.13.26364741 medRxiv
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Background: Large language models (LLMs) configured as virtual patients may expand structured practice of clinical reasoning in health professions education. Before testing effectiveness, it must be established whether students engage with them and whether the resulting scores are complete, reliable, and related to performance with real patients. Our earlier pilot randomized trial found very low engagement with a less structured LLM-based approach. Objective: This study aimed to assess the feasibility (adherence, acceptability, and data completeness) of a revised, structured LLM-based clinical reasoning laboratory (Laboratorio de Inteligencia Artificial [LIA]) in undergraduate physical therapy education and to explore its measurement properties, including its association with clinical judgment with a real patient assessed with the Lasater Clinical Judgment Rubric (LCJR). Methods: In this single-arm pilot feasibility study, 27 third-year physical therapy students at a Spanish university completed, in 2024-2025, 3 virtual patient cases (lumbar, cervical, and thoracic spine pain) simulated by ChatGPT (GPT-4) over 4 weeks, each twice. ChatGPT scored each attempt from 0 to 4 on the same 10 dimensions of the Lasater Clinical Judgment Rubric (LCJR; 0-40 points) that human assessors applied (1-4 per dimension; 10-40 points) during a real patient encounter. Feasibility outcomes were case completion, data completeness, and satisfaction (0-10). Measurement outcomes were internal consistency and convergent validity (Spearman correlations between model-generated and human LCJR scores). Variability estimates informed the sample size of a future trial. Results: All 27 students were assessed with the LCJR; 22 (81%) completed at least 1 LIA case. Both attempts of the lumbar, cervical, and thoracic cases were completed by 78%, 63%, and 74% of students, respectively. Satisfaction data were available for 15 students (56%; mean 6.0, SD 1.3), and missing secondary data clustered in the third rotation. Internal consistency was excellent for the LCJR (alpha=.96) and ranged from .43 to .90 for model-generated ratings. Model-generated LIA scores clustered near the maximum (mean 36.0, SD 1.4). Among completers, LIA scores correlated weakly with the LCJR (rho=0.25, 95% CI -0.20 to 0.61; rho=0.44, 95% CI 0.05-0.71, when noncompleted attempts were scored as 0). Grade point average correlated almost perfectly with the LCJR (rho=0.96; n=22); after adjustment for it, the LIA-LCJR association disappeared (partial rho=-0.10). A future trial would require approximately 39 students per group (80% power, conservative variance). Conclusions: Delivering the LIA within the curriculum was feasible, but clinical judgment ratings generated by ChatGPT did not reflect those of human assessors with a real patient: they clustered near the maximum and showed no convergent validity once noncompletion was separated from performance. LLM-generated ratings should not be used as outcome or assessment measures without validation against human raters. Case calibration, completion tracking, and clarification of the GPA-LCJR relationship are also needed before a definitive trial. Trial Registration: ClinicalTrials.gov NCT06809634; https://clinicaltrials.gov/study/NCT06809634