Effects of Wearable Vibratory Devices on Arm Function in Subacute Stroke Patients (WEVIB-HEMI)
Effects of Wearable Vibratory Devices for Upper Limb Function Among Subacute Hemiplegic Patients: A Randomized Controlled Trial
調査の概要
詳細な説明
This single-center, prospective, randomized, controlled, parallel-group trial aims to investigate the neurophysiological effects of focal muscle vibration (FMV) delivered via a wearable device. The study will enroll 28 participants (14 per arm, accounting for 20% attrition) diagnosed with unilateral hemiplegia in the subacute stage (3 to 6 months post-stroke). Inclusion requires a Fugl-Meyer Assessment for Upper Extremity (FMA-UE) score between 20 and 50 and a Modified Ashworth Scale (MAS) score indicating mild to moderate spasticity. Exclusion criteria include fixed contractures, severe sensory loss, or other neurological diseases.
Intervention Protocol: Both groups will receive a 45-minute conventional physiotherapy session focusing on range of motion, strengthening, and functional task training, three times per week for 8 weeks. The experimental group (Group A) will additionally wear a portable vibratory device (frequency: 100-120 Hz) on the belly of the affected biceps and forearm extensors for 30 minutes during the therapy session. The device will be applied by a trained physiotherapist. The control group (Group B) receives the same conventional therapy without the vibratory device. Electrical Muscle Stimulation (EMS) will be used as a baseline warm-up for both groups.
Outcomes: The primary outcomes are changes in spasticity (MAS) and motor function (FMA-UE). The secondary outcome is functional independence measured by the Barthel Index. Assessments occur at baseline (Week 0) and post-intervention (Week 8). Data will be analyzed using an intention-to-treat analysis in SPSS v20.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Dr Muhammad Ateeb, PhD Public Health
- 電話番号：+923357333383
- メール：mateeb.oric@tuf.edu.pk
研究連絡先のバックアップ
- 名前：Dr. Anbreena Rasool, Doctor of Physical Therapy
- 電話番号：+92 345 79368
- メール：anbreenarasool.DPT@tuf.edu.pk
研究場所
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Punjab Province
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Faisalābad、Punjab Province、パキスタン、3800
- 募集
- The University of Faisalabad
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参加基準
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Unilateral hemiplegia secondary to stroke
- Age between 30 and 60 years
- Subacute stage (3 to 6 months post-stroke)
- Fugl-Meyer Assessment (FMA) score between 20 and 50
- Able to follow simple verbal commands
Exclusion Criteria:
- Previous peripheral nerve injury or surgery affecting the upper limb
- Fixed contractures or bony fractures in the affected limb
- Complete sensory loss of the upper limb
- Co-existing neurological conditions (e.g., Parkinson's, MS, Dementia)
- Unstable cardiovascular conditions
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：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Wearable Vibration + Physiotherapy
Participants receive conventional physiotherapy (45 min) plus a wearable vibratory device applied to the affected upper limb for 30 minutes during the session.
Sessions occur 3 times/week for 8 weeks.
|
A portable, battery-operated device worn on the forearm.
It delivers high-frequency focal vibration (100-120 Hz) to the muscle belly (biceps/forearm extensors) to reduce spasticity and facilitate motor recruitment.
|
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アクティブコンパレータ：Conventional Physiotherapy Only
Participants receive conventional physiotherapy (45 min) without the vibratory device.
Sessions occur 3 times/week for 8 weeks.
|
A portable, battery-operated device worn on the forearm.
It delivers high-frequency focal vibration (100-120 Hz) to the muscle belly (biceps/forearm extensors) to reduce spasticity and facilitate motor recruitment.
|
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 |
|---|---|---|
|
Change in Upper Limb Spasticity
時間枠：Baseline (Week 0) and Post-intervention (Week 8)
|
Measured by the Modified Ashworth Scale (MAS).
Scale ranges from 0 (no increase in tone) to 4 (rigidity).
A lower score indicates better outcome.
|
Baseline (Week 0) and Post-intervention (Week 8)
|
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Change in Upper Limb Motor Function
時間枠：Baseline (Week 0) and Post-intervention (Week 8)
|
Measured by the Fugl-Meyer Assessment for Upper Extremity (FMA-UE).
Total score ranges from 0 to 66.
A higher score indicates better motor recovery.
|
Baseline (Week 0) and Post-intervention (Week 8)
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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 |
|---|---|---|
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Change in Functional Independence
時間枠：Baseline (Week 0) and Post-intervention (Week 8)
|
Measured by the Barthel Index (BI).
Total score ranges from 0 (totally dependent) to 100 (completely independent).
A higher score indicates better ability to perform activities of daily living.
|
Baseline (Week 0) and Post-intervention (Week 8)
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
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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