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).
調査の概要
状態
研究の種類
入学 (推定)
段階
- 適用できない
参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：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.
|
|
アクティブコンパレータ：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Biodex Balance System
時間枠：Baseline, Week 4, Month 6
|
Baseline, Week 4, Month 6
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Movement Disorder Society-Unified Parkinson's Disease Rating Scale
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Mini-Balance Evaluation Systems Test
時間枠：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
時間枠：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
時間枠：Baseline, Week 4, Month 6
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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
時間枠：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
時間枠：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.
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Baseline, Week 4, Month 6
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Parkinson Fatigue Scale
時間枠：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.
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Baseline, Week 4, Month 6
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Montreal Cognitive Assessment
時間枠：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
時間枠：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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協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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