Home Based Electrical Stimulation on Post-stroke Lower Limb Tightness.
The Feasibility and Impact of A Home-Based NMES Program on Post-Stroke Lower Limb Spasticity
Spasticity is a common complication post stroke. Post-stroke spasticity along with weakness and lack of coordination result in gait abnormalities and functional limitations. Recent treatment option include neuromuscular electric stimulation (NMES), a form of therapy that applies electrical currents to produce contraction of innervated muscle by depolarizing local motor nerves. Currently, there are wide varieties of NMES devices available commercially for consumer.
The main purpose of this study is to evaluate the feasibility and acceptability of a home-based NMES program on lower limb spasticity in patient with post-stroke more than 6 months and to assess the impact of the program. This is single arm prospective intervention study. Patient will apply home-based NMES on their leg for 20 minutes, 5 days a week for 4 weeks. At the end of the study, an outcome measures will be assessed and patient will be required to answer a questionnaires on their experience.
調査の概要
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Tze Yang Chung
- 電話番号：+60192226593
- メール：chungty@ummc.edu.my
研究場所
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Kuala Lumpur、マレーシア、59100
- 募集
- University Malaya Medical Center
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コンタクト：
- Tze Yang Chung
- 電話番号：+60192226593
- メール：chungty@ummc.edu.my
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Post stroke (hemorrhagic or ischemic) with ankle plantarflexor (gastrocnemius and soleus) spasticity MAS 1+ to MAS 3,
- Post stroke more than 6 months,
- At least 18 years old,
- Able to ambulate 10 meter either independently or aided (single point stick or quadripod)
- Compliant to outpatient therapy.
- Minimal cognitive (MMSE> 24) and minimal sensory impairment,
- Stable neurological and medical condition
Exclusion Criteria:
- Introduction or changes in anti-spastic medication dose within 3 months or during study period,
- Receiving intervention for spasticity (eg BoNT or serial casting) within 3 months or during research period,
- New neurological condition/disease,
- Presence of contraindications to NMES, which is: Pregnancy, Malignancy, Presence of electronic implant eg cardiac pacemaker, cardioverter defibrillator, Uncontrolled seizure/epilepsy, Infected tissues/ tuberculosis or osteomyelitis, Impaired lower limb circulation/ DVT/ thrombophlebitis, Recent fracture or osteoporosis, Actively bleeding tissue or person with untreated hemorrhagic disorder, Damaged or skin diseases at the affected lower limb
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：他の
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- 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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実験的：Home-based Electrical Stimulation Program for lower limb spasticity
Single arm prospective intervention study to assess the feasibility and impact of a home-based program.
Patient will apply home-based NMES on their leg for 20 minutes, 5 days a week for 4 weeks.
At the end of the study, an outcome measures will be assessed and patient will be required to answer a questionnaires on their experience.
|
Home-based NMES program on spastic leg. The NMES pre-programmed dosage (locked): NMES waveform is biphasic PC, Frequency 50Hz, pulse width 400µs, ON:OFF 10s:20s and current amplitude: individual maximum tolerated to achieve ankle dorsiflexion.
他の名前：
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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 |
|---|---|---|
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Retention Rate
時間枠：4 weeks
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The proportion of patients who completed the program.
Patient completed divided with patient recruited, expressed in percentage (%).
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4 weeks
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Acceptability
時間枠：4 weeks
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Acceptability as evaluated at the end of the intervention by brief structured questionnaire developed for this study using 5 point Likert scale with 1 (strongly agree) and 5 (strongly agree).
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4 weeks
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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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Clinical measurement of spasticity
時間枠：4 weeks (pre and post assessment)
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Ankle dorsiflexor (gastroc) Modified Ashworth Scale (MAS) as measured in MAS grade 1, 1+, 2, 3, 4
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4 weeks (pre and post assessment)
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Clinical measurement of spasticity
時間枠：4 weeks (pre and post assessment)
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Modified Tardieu Scale (R1 and R2 angle of ankle dorsiflexion)
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4 weeks (pre and post assessment)
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Ankle dorsiflexion muscle strength
時間枠：4 weeks (pre and post assessment)
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Manual Muscle Testing as measured in 0-5 (with 0 no movement and 5 is the strongest)
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4 weeks (pre and post assessment)
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Functional Outcome
時間枠：4 weeks (pre and post assessment)
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10 meter walking test
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4 weeks (pre and post assessment)
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Raja Nabila BT Raja Mohamed Anuar、University Malaya Medical Center
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
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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