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Characterizing Response to Personalized Intervention in Lower Limb Prosthesis Users: A Sensor-Based Approach to Rehabilitation

Nataletti, S.; Bartloff, J.; Cave, J.; Wyneken, H.; Wacek, A.; McGuire, M.; Hoppe-Ludwig, S.; Banerjee, A.; Maronati, R.; Hendershot, B.; Looft, J. M.; Jayaraman, A.

2025-07-22 rehabilitation medicine and physical therapy
10.1101/2025.07.21.25331936 medRxiv
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QuestionCan a personalized post-rehabilitation intervention, guided by wearable sensor data, clinical outcomes, and expert review, improve functional mobility in individuals with lower limb amputation (LLA) who exhibit unmet mobility needs? DesignProspective observational study with a nested intervention. ParticipantsFifty-eight adults with LLA, recruited from military and civilian sites. Based on three months of community-based monitoring and clinical assessments, an expert panel identified 26 individuals as requiring additional support; 19 completed the intervention. InterventionTailored combinations of physical therapy, prosthetic adjustments, and/or motivational interviewing delivered over three months based on individual needs and goals. Outcome MeasuresPerformance-based tests, patient-reported outcomes, daily step count, and progress toward self-defined mobility goals. Change from baseline was assessed using minimal clinically important difference (MCID) thresholds. Between-group comparisons (Responders vs Non-Responders), and equivalence testing with a non-intervention group were conducted. ResultsFollowing intervention, 68% of participants improved in functional outcomes, goal attainment, or both. Among Responders, 46% exceeded the MCID for sit-to-stand performance, with 17- 33% meeting thresholds for other mobility and quality-of-life measures. Responders had lower body mass index, fewer comorbidities, showed greater gains in step count, physical performance and prosthesis-related quality of life. Equivalence testing showed Amputee Mobility Predictor scores among Sustained Responders became statistically comparable to those who never required intervention. Most participants maintained gains at follow-up. ConclusionA personalized intervention approach guided by integrated data and experts review may improve real-world outcomes in individuals with LLA. These findings support reassessment to identify residual needs and deliver targeted support beyond standard care.

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