Telerehabilitation Versus Face-to-Face LSVT BIG in Individuals With Parkinson Disease (NCT07630792) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Telerehabilitation Versus Face-to-Face LSVT BIG in Individuals With Parkinson Disease
40 participantsStarted 2026-06-20
Plain-language 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).
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Diagnosis of idiopathic Parkinson's disease
* Hoehn and Yahr stage 1-3
* Montreal Cognitive Assessment (MoCA) score ≥ 21
* Ability to use a smartphone, tablet, or computer
* Access to internet connection and basic digital literacy
* Participation in activities outside the home at least 3 days per week
Exclusion Criteria:
* Diagnosis of a neurological condition other than idiopathic Parkinson's disease
* Change in antiparkinsonian medication regimen during the study period
* History of deep brain stimulation
* Visual or hearing impairment that would prevent participation in treatment or assessments
* Severe cardiovascular, orthopedic, pulmonary, or systemic comorbidity contraindicating exercise
* Diagnosis of severe depression, psychotic disorder, or uncontrolled psychiatric illness
* Participation in another structured physiotherapy or rehabilitation program for
* Parkinson's disease within the last three months
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial compares telerehabilitation versus in-person LSVT BIG therapy for Parkinson's disease — given my current stage of PD and mobility level, which version of the therapy do you think would be more appropriate for me to discuss with the study team?
2The trial is measuring balance using the Biodex Balance System and motor function using the MDS-UPDRS — are those outcomes meaningful for where I am in my Parkinson's progression, and would improvements in those areas make a real difference in my daily life?
3Since this trial is listed as 'not yet recruiting,' how long might it be before enrollment opens, and is there a reason to wait for it rather than starting LSVT BIG therapy through standard care now?
4This is a Phase NA study comparing two delivery methods rather than testing a new drug — does that mean the LSVT BIG therapy itself is already established, and what would I be giving up or gaining by participating in the trial versus just receiving it outside of the study?
5If I'm interested in this trial, what logistical factors should I consider — for example, do I need reliable internet and specific equipment at home to be eligible for the telerehabilitation arm, and how might that affect which group I'd be assigned to?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Biodex Balance System
Timeframe: Baseline, Week 4, Month 6
2
Movement Disorder Society-Unified Parkinson's Disease Rating Scale