ISO-101, a Wrist-Worn Isometric Counter-Manoeuvre Device, Improves Blood Pressure Recovery in Orthostatic Hypotension

ISO-101 is a novel wrist-worn device designed to deliver guided upper-limb isometric counter-manoeuvres via a retractable resistance tether with visual feedback. This proof-of-concept study evaluated feasibility, safety and preliminary efficacy in adults with orthostatic hypotension (OH). In a fixed-sequence, within-participant design, each participant completed three active-stand assessments: unassisted; device activation while supine immediately before standing; and device activation immediately after standing. The primary outcome was the proportion of responders, defined a priori as achieving, with device use versus the unassisted condition, [≥]10 mmHg improvement in any one of resting blood pressure, nadir standing blood pressure at 30- 60 s, or reduction in the orthostatic blood-pressure drop (systolic or diastolic). The study was powered to test the responder proportion against a 20% benchmark derived from standard non-pharmacological care. Seventeen participants were enrolled (mean age 72 years; 77% male) and fourteen completed all assessments. Six of fourteen (43%) met the responder definition, exceeding the benchmark (exact binomial p=0.012). When the device was used immediately after standing, responders showed mean (SD) increases of +22.13 (16.29) mmHg systolic and +19.52 (12.47) mmHg diastolic compared with the unassisted stand; pre-stand activation yielded smaller, non-significant changes. No adverse events occurred. Usability was high, with 88% rating the device easy to use and 69% indicating they would use it in daily life. ISO-101 produced clinically meaningful improvements in orthostatic blood pressure in a substantial subset of patients, supporting progression to larger, controlled evaluations. WHAT IS ALREADY KNOWNO_LIOrthostatic hypotension (OH) is common and clinically significant, yet counter-manoeuvres are often poorly implemented in practice. C_LIO_LIWearable assistance for standardised counter-manoeuvres has not previously been tested in OH. C_LI WHAT THIS STUDY ADDSO_LIIn this proof-of-concept study, ISO-101, a guided wrist-worn device, achieved a clinically meaningful and statistically significant responder rate, exceeding that typically observed with standard care. C_LIO_LIResponders demonstrated marked increases in postural blood pressure, the device was rated as highly usable, and no adverse events were reported. C_LI HOW THIS STUDY MIGHT AFFECT RESEARCH, PRACTICE OR POLICYO_LIThese findings highlight the potential for wearable-assisted therapy in OH and support the need for further clinical evaluation. C_LI TRIAL REGISTRATION NUMBERClinicalTrials.gov: NCT06039410