Potential for Recovery of Voluntary Finger Extension After Stroke (PROVES)
Stroke patients with absent voluntary finger extension (VFE) 6-months after stroke are not expected to recover hand function. However, experience from the Queen Square Upper Limb neurorehabilitation service contradicts this view. In this study, we will identify the characteristics of those chronic stroke patients who regain previously absent VFE.
Hundred chronic stroke patients will be recruited with absent/negligible VFE in an external pilot and feasibility study. Transcranial magnetic stimulation will be used to determine the functional integrity of descending white matter pathways. Corticospinal tract integrity to finger extensor muscles will be based on whether motor-evoked potentials are present (MEP+) or absent (MEP-). Reticulospinal tract activity will be assessed by measuring ipsilateral MEP amplitudes and the Start-React response.
All patients will then receive 3-months of neuromuscular electrical stimulation plus home exercise, designed to strengthen wrist/finger extensors, reduce spasticity and increase corticospinal excitability. The primary outcome measure will be restoration of VFE.
It is predicted that VFE will be restored in MEP+ but not MEP- patients. MEP- patients will have higher reticulospinal tract activity associated with spasticity. Restoration of VFE will allow patients to engage in evidence-based upper limb training to improve function e.g. constraint induced movement therapy or repetitive task training.
調査の概要
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：Professor Nick Ward, MD
- 電話番号：+44 20 3448 3486
- メール：n.ward@ucl.ac.uk
研究連絡先のバックアップ
- 名前：Lisa Tedesco Triccas, PhD
- メール：l.triccas@ucl.ac.uk
研究場所
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-
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London、イギリス、WC1N 3BJ
- University College London- Department of Clinical and Movement Neurosciences
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria
- Diagnosed with a Stroke >6 months previously
- Medical Research Council (MRC) grade 0 or 1 in long finger extensors.
Exclusion Criteria
- Presence of spasticity in any wrist/finger flexors (including lumbricals) >2 on Modified Ashworth Scale
- Unable to get hand flat on table top
- Botulinum toxin to long finger or wrist flexors < 24 weeks prior to pre-treatment assessment (i.e. effects should have worn off).
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：診断
- 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：Neuromuscular electrical stimulation (NMES) and home exercise programme
Three month intervention programme of Neuromuscular electrical stimulation (NMES) and home exercise programme
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-Neuromuscular and Electrical Stimulation (NMES): All participants will undergo a NMES treatment programme designed to strengthen wrist and finger extensors. Participants and their carers will receive training in NMES set up from the research physiotherapist. Surface electrodes are placed over the motor points of extensor carpi radialis and extensor digitorum communis to produce wrist and finger extension simultaneously. Home exercise: We aim for all patients to perform the Graded Repetitive Arm Supplementary Program (GRASP) level 1 (for severely affected upper limbs) for a minimum of 60 minutes/day, 5 days/week. Patients will be provided with an exercise book containing written and pictorial instructions for each exercise, and the kits contained inexpensive equipment to complete the exercises. Exercises included strengthening of the arm and hand, range of motion, and gross and fine motor skills. |
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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Voluntary Finger Extension (VFE)
時間枠：Day 1 and Day 90
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Can participants achieve at least 10° of thumb abduction/extension, and at least 10° of extension in a minimum of 2 additional digits (movements need to be repeatable 3 times in 1 minute).
The extent of VFE will be measured using an electronic goniometer.
Extent of finger extension is calculated for each finger as a composite of extension at metacarpophalangeal, proximal and distal interphalangeal joints.
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Day 1 and Day 90
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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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Upper Extremity Fugl-Meyer Assessment
時間枠：Day 1 and Day 90
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Measurement of upper limb motor recovery after stroke
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Day 1 and Day 90
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Hand Dynamometry
時間枠：Day 1 and Day 90
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Measurement of grip strength
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Day 1 and Day 90
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Fugl-Meyer Assessment - Sensory function
時間枠：Day 1 and Day 90
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As of part of the Fugl-Meyer Assessment, this measure is used to evaluate somatosensory function of the upper limbs.
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Day 1 and Day 90
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Modified Tardieu Scale (MTS)
時間枠：Day 1 and Day 90
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MTS is a clinical tool used to assess spasticity.
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Day 1 and Day 90
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KINARM- Passive Stretch Task
時間枠：Day 1 and Day 90
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The KINARM Passive Stretch Task is a quantitative assessment performed with the KINARM robotic assessment system in which the participant's limb is passively displaced by the robot while they are instructed to remain relaxed.
The device applies controlled position- or torque-driven perturbations to one or more joints (typically elbow and/or shoulder) across predefined velocities and ranges of motion.
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Day 1 and Day 90
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Box and Block Test (BBT)
時間枠：Day 1 and Day 90
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BBT is a standard assessment to measure manual dexterity and gross motor coordination of the hands.
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Day 1 and Day 90
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Stroke Impact Scale (SIS)
時間枠：Day 1 and Day 90
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SIS is a self-reported questionnaire designed to measure the multidimensional impact of stroke on a person's life.
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Day 1 and Day 90
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Neurophysiological- Corticospinal Tract Integrity
時間枠：Day 1 and Day 90
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Corticospinal tract integrity is measured using Transcranial Magnetic Stimulation (TMS) to evaluate the functional status of motor pathways in the brain and spinal cord - identified as Motor Evoked Potential Positive (MEP+) or Negative (MEP-).
Resting and Active Motor Threshold will also be measured in addition with the Compound Muscle Action Potential.
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Day 1 and Day 90
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Neurophysiological- Reticulospinal Tract Integrity
時間枠：Day 1 and Day 90
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This will be assessed using the Start React Protocol and measurement of ipsilateral Motor Evoked Potentials (iMEPs).
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Day 1 and Day 90
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Neurophysiological- Somatosensory Evoked Potentials
時間枠：Day 1 and Day 90
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Median nerve somatosensory evoked potentials will be measured using Electroencephalography (EEG).
The measures will mainly involve recording cortical responses to peripheral nerve stimulation.
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Day 1 and Day 90
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協力者と研究者
捜査官
- 主任研究者：Nick Ward, MD、University College, London
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
本研究に関する用語
その他の研究ID番号
- 367119
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