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

Официальное название

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

Обзор

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).

Вмешательства

• Другое 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.
• Другое 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.

Первичные конечные точки

• Biodex Balance System [Срок оценки: Baseline, Week 4, Month 6]
• Movement Disorder Society-Unified Parkinson's Disease Rating Scale [Срок оценки: Baseline, Week 4, Month 6]

Вторичные конечные точки (8)

• Mini-Balance Evaluation Systems Test [Срок оценки: Baseline, Week 4, Month 6]
• Timed Up and Go Test [Срок оценки: Baseline, Week 4, Month 6]
• Parkinson's Disease Questionnaire-39 [Срок оценки: Baseline, Week 4, Month 6]
• Beck Depression Inventory [Срок оценки: Baseline, Week 4, Month 6]
• Parkinson's Disease Sleep Scale [Срок оценки: Baseline, Week 4, Month 6]
• Parkinson Fatigue Scale [Срок оценки: Baseline, Week 4, Month 6]
• Montreal Cognitive Assessment [Срок оценки: Baseline, Week 4, Month 6]
• Global Rating of Change Scale [Срок оценки: Week 4, Month 6]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07630792 · E-83460662-050.04-1593414

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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