Telerehabilitation Versus Face-to-Face LSVT BIG in Individuals With Parkinson Disease
2026년 6월 9일 업데이트: 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).
연구 개요
상태
상태
아직 모집하지 않음
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
중재적
등록 (추정된)
등록
40
단계
단계
- 해당 없음
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
2
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
활성 비교기: 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.
|
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.
|
|
활성 비교기: 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.
|
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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Biodex Balance System
기간: Baseline, Week 4, Month 6
|
Baseline, Week 4, Month 6
|
|
|
Movement Disorder Society-Unified Parkinson's Disease Rating Scale
기간: Baseline, Week 4, Month 6
|
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
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Mini-Balance Evaluation Systems Test
기간: Baseline, Week 4, Month 6
|
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.
|
Baseline, Week 4, Month 6
|
|
Timed Up and Go Test
기간: Baseline, Week 4, Month 6
|
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.
|
Baseline, Week 4, Month 6
|
|
Parkinson's Disease Questionnaire-39
기간: Baseline, Week 4, Month 6
|
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.
|
Baseline, Week 4, Month 6
|
|
Beck Depression Inventory
기간: Baseline, Week 4, Month 6
|
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.
|
Baseline, Week 4, Month 6
|
|
Parkinson's Disease Sleep Scale
기간: Baseline, Week 4, Month 6
|
Sleep quality and sleep-related disturbances will be assessed using the 15-item Parkinson's Disease Sleep Scale.
Each item is scored on a visual analog scale from 0 to 10. Lower total scores indicate poorer sleep quality.
|
Baseline, Week 4, Month 6
|
|
Parkinson Fatigue Scale
기간: Baseline, Week 4, Month 6
|
Fatigue severity and its impact on daily functioning will be assessed using the 16-item Parkinson Fatigue Scale.
Each item is scored from 1 to 5, with higher total scores indicating greater fatigue.
|
Baseline, Week 4, Month 6
|
|
Montreal Cognitive Assessment
기간: Baseline, Week 4, Month 6
|
Cognitive function will be assessed using the Montreal Cognitive Assessment, evaluating attention, executive functions, memory, language, visuospatial skills, abstract thinking, and orientation.
Total scores range from 0 to 30, with higher scores indicating better cognitive performance.
|
Baseline, Week 4, Month 6
|
|
Global Rating of Change Scale
기간: Week 4, Month 6
|
Patient-perceived change in overall condition will be assessed using the Global Rating of Change Scale.
Scores range from -2 (much worse) to +2 (much better), with higher scores indicating greater perceived improvement.
|
Week 4, Month 6
|
공동 작업자 및 조사자
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연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
연구 시작
2026년 6월 20일
기본 완료 (추정된)
기본 완료
2027년 12월 30일
연구 완료 (추정된)
연구 완료
2028년 6월 30일
연구 등록 날짜
최초 제출
최초 제출
2026년 6월 2일
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
2026년 6월 2일
처음 게시됨 (실제)
처음 게시됨
2026년 6월 5일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
2026년 6월 11일
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
2026년 6월 9일
마지막으로 확인됨
마지막으로 확인됨
2026년 6월 1일
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