Effect of Bilateral TENS With TOT on Upper Limb Function in Patients With Chronic Stroke
2021年4月19日 更新者：Shamay Ng、The Hong Kong Polytechnic University
A Randomized, Controlled Clinical Trial of Upper Limb Training With Bilateral Cutaneous Electrical Stimulation to Improve Upper Limb Functions in Patients With Chronic Stroke
On the basis that the combined use of Uni-TENS and TRT is an effective intervention in upper limb recovery, and the advantage of Bi-TENS eliciting extra neural pathway in the intact hemisphere to facilitate the motor recovery, There is a research gap in whether the Bi-TENS over both the paretic and non-paretic limbs could probably augment the treatment effects of TOT in upper limb motor control in people with stroke.
調査の概要
状態
完了
条件
詳細な説明
The purpose of this study is to determine whether Bi-TENS+TOT was superior to Uni-TENS+TOT, Placebo-TENS+TOT alone and no active treatment in improving the upper limb motor control and upper limb function and community integration in people with chronic stroke.
The null hypothesis will be that Bi-TENS+TOT is not significantly different from Uni-TENS+TOT,Placebo-TENS+TOT alone and no active treatment in improving the upper limb motor control and upper limb function and community integration in people with chronic stroke.
研究の種類
介入
入学 (実際)
120
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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Hong Kong、香港
- The Hong Kong Polytechnic 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
50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:
- Subjects will be recruited from local self-help groups through poster advertising.
- Subjects will be included if they are between 50 and 80 years of age
- Have been diagnosed with ischaemic brain injury or intracerebral hemorrhage by MRI or computed tomography within the previous 1 to 10 years
- have volitional control of the non-paretic arm and at least minimal antigravity movement in the shoulder of the paretic arm,
- have at least 5º in wrist extension in the antigravity position,
- score > 6 out of 10 in the Abbreviated Mental Test, and
- are able to follow instructions and give informed consent.
Exclusion Criteria:
• have any additional medical, cardiovascular or orthopedic condition
- use a cardiac pacemaker
- have receptive dysphasia
- have a significant upper limb peripheral neuropathy
- are involved in drug studies or other clinical trials, or
- have severe shoulder, elbow, wrist or finger contractures that would preclude a passive range of motions of the arm, and
- have a skin allergy that would prevent electrical stimulation.
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：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：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
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アクティブコンパレータ：Bilateral TENS (Bi-TENS) group
All subjects will undergo 20 sessions of their assigned intervention (60 minutes, thrice a week, for 8 weeks).
All subjects will receive 60 minutes task-oriented upper limb training (TOT) with bilateral electrical stimulation
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Task-Oriented Training (TOT) is a goal-directed exercise therapy, which help the people derive optimal control strategies for solving specific motor problems in real environment.
In this study, TOT included stretching exercises, mobilizing exercise, strengthening exercises, seated reaching tasks, dexterity training and bimanual practice.
The stimulator was 120z Dual-Channel TENS Unit (ITO PHYSITHERAPY&REHABILITION CO., LTD, Tokyo, Japan).
The parameter (100 Hz, 0.2 ms square pulses, intensity barely below the motor threshold) of TENS followed our previous study
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プラセボコンパレーター：Unilateral TENS (uni-TENS) group
All subjects will undergo 20 sessions of their assigned intervention (60 minutes, thrice a week, for 8 weeks).
All subjects will receive 60 minutes task-oriented upper limb training (TOT) with unilateral electrical stimulation on paretic side and sham electrical stimulation on the non-paretic side
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Task-Oriented Training (TOT) is a goal-directed exercise therapy, which help the people derive optimal control strategies for solving specific motor problems in real environment.
In this study, TOT included stretching exercises, mobilizing exercise, strengthening exercises, seated reaching tasks, dexterity training and bimanual practice.
The stimulator was 120z Dual-Channel TENS Unit (ITO PHYSITHERAPY&REHABILITION CO., LTD, Tokyo, Japan).
The parameter (100 Hz, 0.2 ms square pulses, intensity barely below the motor threshold) of TENS followed our previous study
A identical-looking TENS devices that electrical circuit has been disconnected.
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プラセボコンパレーター：Placebo group
All subjects will undergo 20 sessions of their assigned intervention (60 minutes, thrice a week, for 8 weeks).
All subjects will receive 60 minutes task-oriented upper limb training (TOT) with bilateral sham electrical stimulation
|
Task-Oriented Training (TOT) is a goal-directed exercise therapy, which help the people derive optimal control strategies for solving specific motor problems in real environment.
In this study, TOT included stretching exercises, mobilizing exercise, strengthening exercises, seated reaching tasks, dexterity training and bimanual practice.
A identical-looking TENS devices that electrical circuit has been disconnected.
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介入なし：Control group
No Active intervention
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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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Fugl Meyer Assessment on Upper Extremity (FMA-UE)
時間枠：Pre-intervention, Mid-intervention (4 weeks), Post-intervention (8 weeks), Follow-up 1 month (12 weeks), Follow-up 3 months (20 weeks)
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FMA-UE was used for evaluating the upper limb motor control from proximal to distal part of the limb, and voluntary movement from synergistic to isolated in people with stroke.
The FMA-UE has shoulder-arm, wrist, hand and coordination and speed subsections.
The score of shoulder-arm, wrist, hand and coordination and speed sub-scale are combined to compute the total score.
The maximum total score is 66, with 33 items and ordinal scoring from 0 to 2. A higher score of FMA-UE indicated a higher level of upper limb motor control.
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Pre-intervention, Mid-intervention (4 weeks), Post-intervention (8 weeks), Follow-up 1 month (12 weeks), Follow-up 3 months (20 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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Jacket Test (JT)
時間枠：Pre-intervention, Mid-intervention (4 weeks), Post-intervention (8 weeks), Follow-up 1 month (12 weeks), Follow-up 3 months (20 weeks)
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Jacket Test is one of the items in the Physical Performance Test.
The subject is required to don a jacket or a cardigan sweater such that it is straight on his or her shoulders, and then remove it completely.
The time for completing the task is recorded.(Rueben
DB et al, 1990) This Jacket Test (JT) can be used to evaluate the functional mobility of the upper limbs as the test involves abduction of the shoulder joint, flexion and extension of the elbow joint and gripping with the hands.
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Pre-intervention, Mid-intervention (4 weeks), Post-intervention (8 weeks), Follow-up 1 month (12 weeks), Follow-up 3 months (20 weeks)
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Maximal Voluntary Contraction (MVC)-Peak Torque
時間枠：Pre-intervention, Mid-intervention (4 weeks), Post-intervention (8 weeks), Follow-up 1 month (12 weeks), Follow-up 3 months (20 weeks)
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The force data would be recorded by the self-made load cell.
And the mean value peak torque of the joint would be calculated by the force and the length from the wrist joint to the head of 3rd metacarpal.
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Pre-intervention, Mid-intervention (4 weeks), Post-intervention (8 weeks), Follow-up 1 month (12 weeks), Follow-up 3 months (20 weeks)
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Action Research Arm Test (ARAT)
時間枠：Pre-intervention, Mid-intervention (4 weeks), Post-intervention (8 weeks), Follow-up 1 month (12 weeks), Follow-up 3 months (20 weeks)
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ARAT will be used to assess the 4 aspects of upper limb function(grasp, grip, pinch and gross arm movement).
This scale is consistent of 19 items.
The quality of performance on each item is rated from 0-3, so the score of ARAT is ranged from 0-57.
The score of rasp, grip, pinch and gross arm movement sub-scale are combined to compute the total score.
The scores for the 15 tasks will be summed and then averaged to yield the mean functional ability score.
A higher ARAT score indicated a higher upper limb motor function.
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Pre-intervention, Mid-intervention (4 weeks), Post-intervention (8 weeks), Follow-up 1 month (12 weeks), Follow-up 3 months (20 weeks)
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The Range of Motion (ROM) of Upper Limb Joints
時間枠：Pre-intervention, Mid-intervention (4 weeks), Post-intervention (8 weeks), Follow-up 1 month (12 weeks), Follow-up 3 months (20 weeks)
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With 0° shoulder flexion and 90° elbow flexion, the forearm and wrist will be placed in a neutral position in the relaxed phase. When the task begins, the subjects will be asked to perform the full range of motion for wrist flexion/extension. With 90° shoulder flexion and 0° elbow flexion, the forearm will be placed in a neutral position in the relaxed phase. When the task begins, the subjects will be asked to perform the full range of motion for elbow flexion/extension. All the subjects will be requested to perform their joint ROM to the best of their abilities. |
Pre-intervention, Mid-intervention (4 weeks), Post-intervention (8 weeks), Follow-up 1 month (12 weeks), Follow-up 3 months (20 weeks)
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Motor Activity Log (MAL)
時間枠：Pre-intervention, Mid-intervention (4 weeks), Post-intervention (8 weeks), Follow-up 1 month (12 weeks), Follow-up 3 months (20 weeks)
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The MAL questionnaire will be used to assess how frequently and how well a person uses the paretic upper limb in 30 activities of daily life in a semi-structured interview.
Based on a six-point ordinal scale, subjects will be required to rate (1) the amount of use (AOU), and (2) the quality of movement (QOM) when performing these 30 tasks in real life situations.
Each task was rated from 0 to 5. The score of the 30 activities of daily life were combined to compute the total score of MAL-AOU and MAL-QOM, respectively.
Hence, the total score of AOU and QOM component were rated from 0 to 150.
The higher MAL-AOU score indicated a higher frequency use of the paretic upper limb, and the higher MAL-QOM score indicated a higher movement quality of the paretic upper limb.
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Pre-intervention, Mid-intervention (4 weeks), Post-intervention (8 weeks), Follow-up 1 month (12 weeks), Follow-up 3 months (20 weeks)
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Chinese Version of Community Integration Measure (CIM)
時間枠：Pre-intervention, Mid-intervention (4 weeks), Post-intervention (8 weeks), Follow-up 1 month (12 weeks), Follow-up 3 months (20 weeks)
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The Chinese version of CIM was used to assess the level of community integration of the subjects.
The CIM-C has been shown to have good internal consistency and good test-retest reliability for people with stroke .
CIM has 10 items, each item rate from 1-5, giving a minimum score of 10 to a maximum of 50.
A higher score indicated a higher level of community integration.
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Pre-intervention, Mid-intervention (4 weeks), Post-intervention (8 weeks), Follow-up 1 month (12 weeks), Follow-up 3 months (20 weeks)
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Maximal Voluntary Contraction (MVC)-Cocontraction Ratio
時間枠：Pre-intervention, Mid-intervention (4 weeks), Post-intervention (8 weeks), Follow-up 1 month (12 weeks), Follow-up 3 months (20 weeks)
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EMG signal of Radial Carpi Extensor and Ulnar Carpi Flexor for both affected and unaffected side would be recorded by the surface EMG electrodes when asked the subjects to perform the MVC of wrist extension and flexion for 5s in each trial.
Each movement would perform 3 times.
The data of the 3 trials will be averaged.
The co-contraction ratio would be calculated by the iEMG area of antagonist to total (agonist+antagonist), which would be captured for 0.5s from the window began at 0.25s before and ended at 0.25s after the peak value of MVC.
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Pre-intervention, Mid-intervention (4 weeks), Post-intervention (8 weeks), Follow-up 1 month (12 weeks), Follow-up 3 months (20 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。
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)
2016年11月24日
一次修了 (実際)
2020年10月24日
研究の完了 (実際)
2020年10月24日
試験登録日
最初に提出
2017年4月10日
QC基準を満たした最初の提出物
2017年4月12日
最初の投稿 (実際)
2017年4月13日
学習記録の更新
投稿された最後の更新 (実際)
2021年5月13日
QC基準を満たした最後の更新が送信されました
2021年4月19日
最終確認日
2021年4月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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