Stroke Gait Rehabilitation Using Functional Electrical Stimulation
2021年2月17日 更新者：Trisha Kesar, PT, PhD、Emory University
Cortical and Spinal Correlates of Post-stroke Gait Rehabilitation
The study is a prospective interventional study to assess the changes in corticospinal excitability and spinal reflex excitability of in response to rehabilitative strategies and protocols that are commonly used during physical therapy treatment of gait disorders among post-stroke subjects.
As part of this protocol, 55 individuals with chronic stroke will be assigned to either Cohort 1 or Cohort 2, and will participate in 1-18 gait training sessions.
If interested, study participants can also complete both study cohorts sequentially (with at least 3-weeks duration between switching from one cohort to the second).
The study examines the effects among two cohorts of post stroke patients.
Cohort 1 will participate in 18 sessions of fast treadmill walking plus Functional Electrical Stimulation (FastFES) and Cohort 2 will participate in 1-3 sessions of FastFES and fast walking without FES.
調査の概要
状態
完了
条件
詳細な説明
Stroke is the number one cause of disability. Difficulty with walking affects most stroke survivors. Walking deficits (e.g. reduced ankle flexion during swing phase, decreased forward propulsion during terminal stance) can cause risks of falls, slow walking speed, increased effort of walking, and difficulties with activities of daily living. Restoration of walking ability can improve quality of life, and is perceived as a major goal of rehabilitation by stroke survivors. Examples of interventions that are used to rehabilitate walking post-stroke are functional electrical stimulation, fast treadmill walking, and bio- feedback. While recent research has focused on comparing the effectiveness of different gait rehabilitation interventions, the neural and biomechanical mechanisms underlying different gait rehabilitation strategies are unknown. FastFES is a novel gait training intervention that combines the beneficial effects of two independent interventions: Fast treadmill walking and FES. The FastFES intervention incorporates principles of physiology, biomechanics, motor control and learning, and predictions of forward-dynamic gait simulations to improve post-stroke gait.
The overall purpose of this protocol is to assess the biomechanical and neurophysiologic effects of rehabilitative strategies and protocols that are commonly used during physical therapy treatment of gait disorders post-stroke among two cohorts of people. Aim 1 of the study will assess the changes in gait biomechanics, corticospinal excitability, and walking function during 18 sessions of gait retraining, with participants in Cohort 1. Aim 2 of the study assesses the effect of parameters such as walking speed (slow, fast, variable, split-belt walking), functional electrical stimulation parameters (short-term changes induced by fast versus FastFES, stimulation intensity, number of muscles stimulated), and bio-feedback on within-session changes in gait biomechanics, walking function, and corticospinal excitability, among participants in Cohort 2.
Within Cohort 1, participants will receive identical treatment throughout the 18 training sessions (i.e. FastFES training). Within Cohort 2, participants will participate in 3 training sessions of both FastFES and fast walking training, with a 3-week break between the two types of training.
研究の種類
介入
入学 (実際)
24
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Georgia
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Atlanta、Georgia、アメリカ、30322
- Emory University
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
30年～80年 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- Chronic stroke (>6 months post stroke)
- First (single) lesion
- Able to walk with or without the use of a cane or walker
- Sufficient cardiovascular health and ankle stability to walk for 6 minutes at a self-selected speed without an orthoses
- Resting heart rate 40-100 beats per minute
- Resting blood pressure between 90/60-70/90
Exclusion Criteria:
- Evidence of moderate/ severe chronic white matter disease or cerebellar stroke on MRI
- Cerebellar signs (ataxic ("drunken") gait or decreased coordination during rapid alternating hand or foot movements
- Insulin dependent diabetes
- History of lower extremity joint replacement
- Score of >1 on question 1b and >0 on question 1c on NIH Stroke Scale
- Inability to communicate with investigators
- Neglect/hemianopia, or unexplained dizziness in last 6 months
- Neurologic conditions other than stroke
- Orthopedic problems in the lower limbs or spine (or other medical conditions) that limit walking
- Contraindications to transcranial magnetic stimulation (TMS) are: history of seizures, metal implants in the head or face, history of recurring or severe headaches/migraine, headache within the past 24 hours, presence of skull abnormalities or fractures, hemorrhagic stroke, history of dizziness, syncope, nausea, or loss of consciousness in the past 12 months
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：非ランダム化
- 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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実験的：Cohort 1 - FastFES Training
Participants with chronic stroke in Cohort 1 will receive 18 training sessions of FastFES (fast treadmill walking with electrical stimulation).
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Functional electrical stimulation (FES) is a technique that causes a muscle to contract through the use of an electrical current.
The therapist applies an electrical current to either the skin over the nerve, or over the bulk of the muscle, and this will cause a muscle contraction.
The FES is delivered to 2 muscle groups (dorsiflexor and plantarflexor) timed appropriately with the gait cycle.
FastFES gait training sessions may comprise up to six 6-minute bouts of walking with rest breaks between bouts (total 30-minutes of walking).
The last training bout (bout 6) may comprise 6-minutes of over ground walking, during which subjects will be asked to walk as fast as they can.
For safety, a physical therapist will walk with and guard the subject during over ground walking.
他の名前：
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実験的：Cohort 2 - FastFES and Fast Walking
Participants with chronic stroke in Cohort 2 who complete 3 sessions of FastFES and 3 sessions of fast walking.
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Functional electrical stimulation (FES) is a technique that causes a muscle to contract through the use of an electrical current.
The therapist applies an electrical current to either the skin over the nerve, or over the bulk of the muscle, and this will cause a muscle contraction.
The FES is delivered to 2 muscle groups (dorsiflexor and plantarflexor) timed appropriately with the gait cycle.
FastFES gait training sessions may comprise up to six 6-minute bouts of walking with rest breaks between bouts (total 30-minutes of walking).
The last training bout (bout 6) may comprise 6-minutes of over ground walking, during which subjects will be asked to walk as fast as they can.
For safety, a physical therapist will walk with and guard the subject during over ground walking.
他の名前：
Fast walking training sessions will be similar to FastFES in duration, dosage, structure but no FES will be provided.
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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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Change in Motor Evoked Potentials (MEP) Amplitude Measure in milliVolt (mV) of FastFES Versus Fast Walking After 3 Training Sessions in Cohort 2
時間枠：Baseline, week 3 (after 3 sessions of one intervention), week 6 (after 3 sessions of the other intervention)
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Change from baseline in MEP amplitude (transverse abdominal (TA) muscle) is used as a measure of corticospinal excitability that is assessed using a non-invasive technique called transcranial magnetic stimulation (TMS).
Electrical activity from muscles in response to the TMS will be collected using surface electromyography (EMG) sensors attached to muscles that play critical roles during FastFES versus Fast walking.
TMS will be delivered using two Magstim 200 stimulators connected via a BiStim module.
An average of 10 TMS-evoked MEP responses will be used to comparing mean peak-to-peak MEP amplitudes in response to suprathreshold TMS delivered to the hotspot.
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Baseline, week 3 (after 3 sessions of one intervention), week 6 (after 3 sessions of the other intervention)
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Change in H-Reflex /M-Wave (Hmax/Mmax) Ratio Among FastFES Versus Fast Walking After 3 Training Sessions in Cohort 2
時間枠：Baseline, week 3 (after 3 sessions of one intervention), week 6 (after 3 sessions of the other intervention)
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Change from baseline in (Hmax/Mmax) ratio is used as a measure of spinal reflex excitability, that is assessed using peripheral electrical stimulation delivered to the nerves innervating the ankle muscles.
An electrical stimulation electrode is placed just above the knee, and used as the anode for tibial nerve stimulation.
Electrical stimulation is delivered via surface electrodes in a static position to the popliteal fossa.
The subject's EMG activity will be recorded while the cathode is moved at the back of the knee to determine the location that provides the best EMG response (H-reflex).
EMG activity will be recorded while 50-60 electrical stimuli (short 1 ms square pulses, ranging in intensity in milliAmpere(mA) 1-80), 7-10 seconds apart, are delivered to the muscle.
Also 5-20 electrical stimulus pulses at intensities are delivered that elicit a percentage of the maximum reflex response.
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Baseline, week 3 (after 3 sessions of one intervention), week 6 (after 3 sessions of the other intervention)
|
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Change in Motor Evoked Potentials (MEP) Amplitude Measure in milliVolt (mV) of FastFES After 18 Training Sessions in Cohort 1
時間枠：Baseline and up to 6 weeks
|
Change from baseline in MEP amplitude (TA muscle in a resting state) is used as a measure of corticospinal excitability that is assessed using a non-invasive technique called transcranial magnetic stimulation (TMS).
Electrical activity from muscles in response to the TMS will be collected using surface electromyography (EMG) sensors attached to muscles that play critical roles during FastFES versus Fast walking.
TMS will be delivered using two Magstim 200 stimulators connected via a BiStim module.
An average of 10 TMS-evoked MEP responses will be used to comparing mean peak-to-peak MEP amplitudes in response to suprathreshold TMS delivered to the hotspot.
|
Baseline and up to 6 weeks
|
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Change in H-Reflex /M-Wave (Hmax/Mmax) Ratio Among FastFES Versus Fast Walking After 18 Training Sessions in Cohort 1
時間枠：Baseline and up to 6 weeks
|
Change from baseline in (Hmax/Mmax) ratio is used as a measure of spinal reflex excitability, that is assessed using peripheral electrical stimulation delivered to the nerves innervating the ankle muscles.
An electrical stimulation electrode is placed just above the knee, and used as the anode for tibial nerve stimulation.
Electrical stimulation is delivered via surface electrodes in a static position to the popliteal fossa.
The subject's EMG activity will be recorded while the cathode is moved at the back of the knee to determine the location that provides the best EMG response (H-reflex).
EMG activity will be recorded while 50-60 electrical stimuli (short 1 ms square pulses, ranging in intensity in milliAmpere(mA) 1-80), 7-10 seconds apart, are delivered to the muscle.
Also 5-20 electrical stimulus pulses at intensities are delivered that elicit a percentage of the maximum reflex response.
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Baseline and up to 6 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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Change in Peak Anterior Ground Reaction Force (AGRF) of FastFES Versus Fast Walking After 3 Training Sessions in Cohort 2
時間枠：Baseline, week 3 (after 3 sessions of one intervention), week 6 (after 3 sessions of the other intervention)
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Change from baseline in peak AGRF during treadmill walking will be collected using a treadmill instrumented with two force platforms under each belt.
Motion analysis data will be collected during 15- to 40-second long dynamic walking trials as subjects walk on a treadmill.
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Baseline, week 3 (after 3 sessions of one intervention), week 6 (after 3 sessions of the other intervention)
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Change in Peak Anterior Ground Reaction Force (AGRF) of FastFES Versus Fast Walking After 18 Training Sessions in Cohort 1
時間枠：Baseline and up to 6 weeks
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Change from baseline in peak AGRF during treadmill walking will be collected using a treadmill instrumented with two force platforms under each belt.
Motion analysis data will be collected during 15- to 40-second long dynamic walking trials as subjects walk on a treadmill.
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Baseline and up to 6 weeks
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
協力者
捜査官
- 主任研究者：Trisha Kesar, PT, PhD、Emory University
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2013年8月1日
一次修了 (実際)
2019年5月1日
研究の完了 (実際)
2019年5月1日
試験登録日
最初に提出
2012年8月15日
QC基準を満たした最初の提出物
2012年8月16日
最初の投稿 (見積もり)
2012年8月20日
学習記録の更新
投稿された最後の更新 (実際)
2021年3月10日
QC基準を満たした最後の更新が送信されました
2021年2月17日
最終確認日
2021年2月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- IRB00058363
- 5K01HD079584-02 (米国 NIH グラント/契約)
- 13SDG13320000 (その他の識別子：American Heart Association)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
はい
米国で製造され、米国から輸出された製品。
はい
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