Telerehabilitation Versus Face-to-Face LSVT BIG in Individuals With Parkinson Disease
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).
研究概览
地位
研究类型
注册 (估计的)
阶段
- 不适用
参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
描述
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
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：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.
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有源比较器：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.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Biodex Balance System
大体时间：Baseline, Week 4, Month 6
|
Baseline, Week 4, Month 6
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Movement Disorder Society-Unified Parkinson's Disease Rating Scale
大体时间：Baseline, Week 4, Month 6
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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.
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Baseline, Week 4, Month 6
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Mini-Balance Evaluation Systems Test
大体时间：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.
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Baseline, Week 4, Month 6
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Timed Up and Go Test
大体时间：Baseline, Week 4, Month 6
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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.
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Baseline, Week 4, Month 6
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Parkinson's Disease Questionnaire-39
大体时间：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.
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Baseline, Week 4, Month 6
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Beck Depression Inventory
大体时间：Baseline, Week 4, Month 6
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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.
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Baseline, Week 4, Month 6
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Parkinson's Disease Sleep Scale
大体时间：Baseline, Week 4, Month 6
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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.
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Baseline, Week 4, Month 6
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Parkinson Fatigue Scale
大体时间：Baseline, Week 4, Month 6
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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.
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Baseline, Week 4, Month 6
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Montreal Cognitive Assessment
大体时间：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.
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Baseline, Week 4, Month 6
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Global Rating of Change Scale
大体时间：Week 4, Month 6
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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.
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Week 4, Month 6
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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