Telerehabilitation Versus Face-to-Face LSVT BIG in Individuals With Parkinson Disease
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorBezmialem Vakif University
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Face-to-Face LSVT BIG
Other interventionThe standard LSVT BIG® protocol will be delivered in a clinical setting by a certified physiotherapist. The protocol consists of 16 sessions over four weeks (4 days/week, 1 hour/session). Treatment content includes maximal daily exercises, functional component tasks, "big" gait training, and individually tailored hierarchy tasks. Home exercises will be assigned on treatment days (once) and non-treatment days (twice daily) in accordance with the standard LSVT BIG® protocol.
Telerehabilitation LSVT BIG
Other interventionThe standard LSVT BIG® protocol will be delivered via synchronous video conferencing under physiotherapist supervision. The protocol consists of 16 sessions over four weeks (4 days/week, 1 hour/session). Treatment content includes maximal daily exercises, functional component tasks, "big" gait training, and individually tailored hierarchy tasks. Home exercises will be assigned on treatment days (once) and non-treatment days (twice daily) in accordance with the standard LSVT BIG® protocol.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Face-to-Face LSVT BIGActive comparator 1 intervention
Group B: Telerehabilitation LSVT BIGActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Biodex Balance System
Time frame
Baseline, Week 4, Month 62
Movement Disorder Society-Unified Parkinson's Disease Rating Scale
Motor and non-motor symptom severity will be assessed using Parts I, II, and III of the Movement Disorder Society-Unified Parkinson's Disease Rating Scale. Part I evaluates non-motor symptoms, Part II evaluates motor aspects of daily living, and Part III evaluates clinician-rated motor signs. Each item is scored from 0 (normal) to 4 (severe), with higher total scores indicating greater symptom severity.
Time frame
Baseline, Week 4, Month 6Secondary outcomes
1
Mini-Balance Evaluation Systems Test
Dynamic balance will be assessed using the 14-item Mini-Balance Evaluation Systems Test, evaluating postural responses, anticipatory postural adjustments, dynamic gait, and sensory orientation. Each item is scored from 0 to 2, with a maximum total score of 28. Higher scores indicate better balance performance.
Time frame
Baseline, Week 4, Month 62
Timed Up and Go Test
Functional mobility and dynamic balance will be assessed by measuring the time (in seconds) required to rise from a chair, walk 3 meters, turn, and return to sitting. Longer completion times indicate poorer functional mobility.
Time frame
Baseline, Week 4, Month 63
Parkinson's Disease Questionnaire-39
Health-related quality of life will be assessed using the 39-item Parkinson's Disease Questionnaire-39, covering 8 domains. Each item is scored from 0 to 4, with domain scores ranging from 0 to 100. Higher scores indicate worse quality of life.
Time frame
Baseline, Week 4, Month 64
Beck Depression Inventory
Depressive symptoms will be assessed using the 21-item Beck Depression Inventory. Each item is scored from 0 to 3, with total scores ranging from 0 to 63. Higher scores indicate greater severity of depressive symptoms.
Time frame
Baseline, Week 4, Month 6Locations
Sponsors and contacts
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Bezmialem Vakif University
Lead sponsor
Istanbul University - Cerrahpasa
Collaborator
Source ClinicalTrials.gov
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