Clinical Trial

Telerehabilitation Versus Face-to-Face LSVT BIG in Individuals With Parkinson Disease

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Summary
This prospective, randomized controlled trial will enroll 40 individuals with idiopathic PD (Hoehn \& Yahr stages 1-3, MoCA ≥21). Participants will be randomly assigned in a 1:1 ratio to either a telerehabilitation LSVT BIG group or a face-to-face LSVT BIG group, with randomization stratified by Hoehn \& Yahr stage using a computer-based block randomization system. Both groups will receive the standard LSVT BIG® protocol consisting of 16 sessions over four weeks (4 days/week, 1 hour/session). Treatment content will include maximal daily exercises, functional component tasks, "big" gait training, and individually tailored hierarchy tasks. The telerehabilitation group will receive all sessions via synchronous video conferencing under physiotherapist supervision, while the face-to-face group will receive sessions in a clinical setting. Both groups will be assigned home exercise programs in accordance with the LSVT BIG® protocol, and treatment adherence will be monitored throughout the study. Outcomes will be assessed at baseline, after 4 weeks of treatment, and at 6-month follow-up. Primary outcomes include postural stability and fall risk assessed with the Biodex Balance System (anterior-posterior stability index, mediolateral stability index, general stability index, fall risk index, limits of stability) and motor and non-motor symptom severity assessed with the MDS-UPDRS (Parts I, II, and III). Secondary outcomes include dynamic balance (Mini-BESTest), functional mobility (Timed Up and Go Test, 10-Meter Walk Test), quality of life (PDQ-39), depression (Beck Depression Inventory), sleep quality (Parkinson's Disease Sleep Scale), fatigue (Parkinson Fatigue Scale), cognitive function (MoCA), and treatment satisfaction (Global Rating of Change Scale).
Protocol Amendment History 1 change
critical Primary endpoint(s) modified 2026-06-12
Trial Details
NCT Number NCT07630792
Lead Sponsor Bezmialem Vakif University
Collaborators: Istanbul University - Cerrahpasa
Conditions PARKINSON DISEASE (Disorder), Parkinson Disease (PD), Postural Balance, Parkinson Disease
Enrollment 40 participants
Start Date 2026-06-20
Primary Completion 2027-12-30 (estimated)
Study Completion 2028-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-06-11