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

June 2, 2026 updated by: Bezmialem Vakif University

The Effects of Telerehabilitation and Face-to-Face LSVT BIG Method on Motor and Non-Motor Symptoms in Individuals With Parkinson Disease

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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Face-to-Face LSVT BIG
Participants will receive the standard LSVT BIG® protocol delivered in a clinical setting. The protocol consists of 16 sessions over four weeks (4 days/week, 1 hour/session), including maximal daily exercises, functional component tasks, "big" gait training, and individually tailored hierarchy tasks. Home exercise assignments will be provided in accordance with the standard LSVT BIG® protocol.
Other: Face-to-Face LSVT BIG
The 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.
Active Comparator: Telerehabilitation LSVT BIG
Participants will receive the standard LSVT BIG® protocol delivered via synchronous video conferencing under physiotherapist supervision. The protocol consists of 16 sessions over four weeks (4 days/week, 1 hour/session), including maximal daily exercises, functional component tasks, "big" gait training, and individually tailored hierarchy tasks. Home exercise assignments will be provided in accordance with the standard LSVT BIG® protocol.
Other: Telerehabilitation LSVT BIG
The 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Biodex Balance System
Time Frame: Baseline, Week 4, Month 6
Baseline, Week 4, Month 6
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
Time Frame: Baseline, Week 4, Month 6
Baseline, Week 4, Month 6

Secondary Outcome Measures

Outcome Measure
Time Frame
Mini-Balance Evaluation Systems Test (Mini-BESTest)
Time Frame: Baseline, Week 4, Month 6
Baseline, Week 4, Month 6
Timed Up and Go Test (TUG)
Time Frame: Baseline, Week 4, Month 6
Baseline, Week 4, Month 6
Parkinson's Disease Questionnaire-39 (PDQ-39)
Time Frame: Baseline, Week 4, Month 6
Baseline, Week 4, Month 6
Beck Depression Inventory (BDI)
Time Frame: Baseline, Week 4, Month 6
Baseline, Week 4, Month 6
Parkinson's Disease Sleep Scale (PDSS)
Time Frame: Baseline, Week 4, Month 6
Baseline, Week 4, Month 6
Parkinson Fatigue Scale (PFS)
Time Frame: Baseline, Week 4, Month 6
Baseline, Week 4, Month 6
Montreal Cognitive Assessment (MoCA)
Time Frame: Baseline, Week 4, Month 6
Baseline, Week 4, Month 6
Global Rating of Change Scale (GRoC)
Time Frame: Week 4, Month 6
Week 4, Month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bezmialem Vakif University

Collaborators

Istanbul University - Cerrahpasa

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 20, 2026

Primary Completion (Estimated)

December 30, 2027

Study Completion (Estimated)

June 30, 2028

Study Registration Dates

First Submitted

June 2, 2026

First Submitted That Met QC Criteria

June 2, 2026

First Posted (Actual)

June 5, 2026

Study Record Updates

Last Update Posted (Actual)

June 5, 2026

Last Update Submitted That Met QC Criteria

June 2, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E-83460662-050.04-1593414

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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