Ankle Robot to Reduce Foot Drop in Stroke
Adaptive Ankle Robot Control System to Reduce Foot-drop in Chronic Stroke
調査の概要
詳細な説明
This proposal investigates a novel ankle robot (anklebot) adaptive control approach integrated with treadmill training to reduce foot drop and improve mobility function in chronic hemiparetic stroke survivors. Currently, stroke survivors with foot drop are trained to live with a cane or other assistive device, and often ankle foot orthotics (AFOs) for safety. Neither mediates task-practice or neuromotor recovery.
The investigators have developed an adaptive anklebot controller that detects gait cycle sub-events for precise timing of graded robotics assistance to enable deficit severity-adjusted ankle motor learning in the context of walking. The investigators' pilot findings show that 6 weeks treadmill training with anklebot (TMR) timed to assist swing phase dorsiflexion only is more effective than treadmill alone (TM) to improve free-walking swing dorsiflexion at foot strike, floor-walking speed, and the benefits are retained at 6 weeks post-training. Notably, swing-phase TMR training improved paretic leg push-off, and reduced center-of-pressure sway on standing balance, indicating potential benefits to other elements of gait and balance, beyond those robotically targeted toward foot drop.
This randomized study investigates the hypothesis that 6 weeks TMR is more effective to improve durably gait biomechanics, static, and dynamic balance, and mobility function in chronic stroke survivors with dorsiflexion deficits, compared to TM alone. Aims are to determine the compare effectiveness of 6 weeks TMR vs. TM alone on:
- Independent gait function indexed by gait velocity, swing-phase DF (dorsiflexion), terminal stance push-off.
- Balance function indexed by measures of postural sway (CoP), asymmetric loading in quiet standing, peak paretic A-P forces in non-paretic gait initiation, and standardized scales for balance and fall risk.
- Long-term mobility outcomes, assessed by repeated measures of all key gait and balance outcomes at 6 weeks and 3 months after formal training cessation.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Maryland
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Baltimore、Maryland、アメリカ、21201
- Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
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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:
- Ischemic or hemorrhagic stroke > 2 months prior in men or women
- Residual hemiparesis of the lower extremity that includes symptoms of foot drop
- Capable of ambulating on a treadmill with handrail support
- Already completed all conventional physical therapy
- Adequate language and cognitive function to provide informed consent and participate in testing and training
Exclusion Criteria:
Cardiac history of:
- Unstable angina
- Recent (< 3 months) myocardial infarction
- Congestive heart failure (NYHA category II or higher)
- Hemodynamic valvular dysfunction
- Hypertension that is a contraindication for a bout of treadmill training (>160/100 mmHg on two assessments)
Medical history of:
- Recent hospitalization (< 3 months) for any serious condition leading to significant bed-rest or reduction in mobility function
- Symptomatic peripheral arterial occlusive disease
- Orthopedic or chronic pain conditions restricting exercise
- Pulmonary failure requiring oxygen
- Uncompensated renal failure
- Active cancer
Neurological history and exam consistent with:
- Dementia
- Receptive or global aphasia that confounds testing and training, operationally defined as unable to follow 2-point commands
- Non-stroke neurological disorder restricting exercise (e.g. Parkinson's Syndrome, myopathy)
- Untreated major depression
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 |
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実験的：Treadmill+anklebot
This group will receive gait training on a treadmill while wearing the anklebot with the adaptive control system.
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This intervention employs the use of the adaptive anklebot control system to complement treadmill exercise training over a 6-week intervention period.
他の名前：
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アクティブコンパレータ：Treadmill only
This group will receive gait training on a treadmill, without use of the anklebot.
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This intervention employs the use of a treadmill for gait exercise training over a 6-week intervention period
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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Gait Velocity During Self-selected Overground Walking
時間枠：Change from baseline to: Post 6-week training, 6 weeks after completion, and 3 (or 6) months after completion
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Gait velocity during self-selected overground walking measured in cm/sec
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Change from baseline to: Post 6-week training, 6 weeks after completion, and 3 (or 6) months after completion
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Anterior-posterior Propulsion Forces of Paretic Side During Gait
時間枠：Change from baseline to: Post 6-weeks training, 6 weeks after completion, and 3 (or 6) months
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Newtons: anterior-posterior force generated during push-off phase of the gait cycle
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Change from baseline to: Post 6-weeks training, 6 weeks after completion, and 3 (or 6) months
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Peak Dorsiflexion Angle During Swing Phase of Gait
時間枠：Change from baseline to: Post 6-week training, 6 weeks after completion, and 3 (or 6) months after completion
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Degrees; extent of ankle dorsiflexion to enable foot clearance
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Change from baseline to: Post 6-week training, 6 weeks after completion, and 3 (or 6) months after completion
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Postural Sway Areas During Quiet Standing
時間枠：Change from baseline to: Post 6-week training, 6 weeks after completion, and 3 (or 6) months
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cm^2; extent of postural deviations to assess static postural control
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Change from baseline to: Post 6-week training, 6 weeks after completion, and 3 (or 6) months
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Ratio of Asymmetric Loading in Quiet Standing
時間枠：Change from baseline to: Post 6-week training, 6 weeks after completion, and 3 (or 6) months
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Ratio of Newtons of force per each leg (paretic/nonparetic) while standing quietly
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Change from baseline to: Post 6-week training, 6 weeks after completion, and 3 (or 6) months
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Peak Paretic Push Off Forces During Gait Initiation
時間枠：Change from baseline to: Post 6-week training, 6 weeks after completion, and 3 (or 6) months
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Newtons; magnitude of forward ground reaction forces
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Change from baseline to: Post 6-week training, 6 weeks after completion, and 3 (or 6) months
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協力者と研究者
捜査官
- 主任研究者：Steven J Kittner、Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
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 (見積もり)
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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