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

NCT07630792 | Not Yet Recruiting

• 1 other identifier: E-83460662-050.04-1593414
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

PARKINSON DISEASE (Disorder); Parkinson Disease (PD), Postural Balance; Parkinson Disease

Keywords

Parkinson Disease; LSVT BIG; Telerehabilitation; Motor Symptoms; Non-Motor Symptoms; Balance; Neuroplasticity; Randomized Controlled Trial; Physical Therapy

Outcome Measures

Primary Outcomes (2)

• Biodex Balance System

  Baseline, Week 4, Month 6

• 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.

  Baseline, Week 4, Month 6

Secondary Outcomes (8)

• Mini-Balance Evaluation Systems Test

  Baseline, Week 4, Month 6

• Timed Up and Go Test

  Baseline, Week 4, Month 6

• Parkinson's Disease Questionnaire-39

  Baseline, Week 4, Month 6

• Beck Depression Inventory

  Baseline, Week 4, Month 6

• Parkinson's Disease Sleep Scale

  Baseline, Week 4, Month 6

Study Arms (2)

Face-to-Face LSVT BIG

ACTIVE COMPARATOR

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

Telerehabilitation LSVT BIG

ACTIVE COMPARATOR

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

Interventions

Face-to-Face LSVT BIG OTHER

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.

Face-to-Face LSVT BIG

Telerehabilitation LSVT BIG OTHER

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.

Telerehabilitation LSVT BIG

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: collaborator
• Bezmialem Vakif University: lead

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2026
• First Posted: June 5, 2026
• Study Start (Estimated): June 20, 2026
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: June 11, 2026

Record last verified: 2026-06