The Effects of Mirror Therapy on Upper Extremity in Stroke Patients
2015年11月3日 更新者：Taipei Medical University Hospital
The purpose of this study is to compare treatment efficacy of mirror therapy (MT), mirror therapy combining mesh glove (MG+MT) stimulation, and controlled treatment (CT) in people with stroke.
調査の概要
詳細な説明
55% to 75% of people after stroke have a paretic arm that causes motor impairment.
Among novel rehabilitation interventions, MT was found to be beneficial and comparatively low-cost.
MT reduced motor impairment possibly in part of recruiting the premotor cortex or balancing the neural activation within the primary motor cortex toward the affected hemisphere.
However, the benefits in certain aspects of outcomes are under debate.
Another treatment, MG, can be used to normalize muscle tone, suppress muscle spasticity, enhance residual volitional activity of hand and arm, or even increasing walking speed.
In addition, providing MG stimulation might result in plastic changes in the primary motor cortex, and induced a long-lasting modulated effect on motor cortical excitability.
The possible mechanism of brain plasticity underlying MG is collective with the mechanism behind the MT.
Adding MG to MT might augment the cortical reorganization.
In sum, combining MT with MG may supplement the disadvantage or uncertain effects of MT and broaden the benefited outcomes.
研究の種類
介入
入学 (実際)
60
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
-
-
-
New Taipei City、台湾、23561
- Shuang-Ho Hospital, Taipei Medical University
-
-
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
20年～75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:
- The onset duration more than 3 months
- Demonstration of Brunnstrom stage equal to or above stage III of the affected upper extremity
- No serious cognitive deficits (a score of more than 24 on the Mini Mental State Exam)
- No serious visual and visual-perception impairments
- No concurrent participation in other drug or rehabilitation research
- No serious attention deficits
- No excessive spasticity in any of the joints of the affected UL exclusion criteria
Exclusion Criteria:
- Exhibit physician determined major medical problems or poor physical conditions that would interfere with participation
- Excessive pain in any joint that might limit participation
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：階乗代入
- 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 |
|---|---|
|
実験的：Mirror therapy
mirror box training with or without sham mesh glove stimulation
|
This protocol includes 1 hour mirror therapy and 0.5 hour functional training in a session.
The treatment intensity is 1.5 hours/day, 5 days/week, for 4 weeks.
MT focuses on symmetrical bimanual movements and simultaneously observing the visual feedback of the unaffected upper extremity reflected by the mirror.
他の名前：
|
|
実験的：Mirror therapy + Mesh glove stimulation
Mirror therapy combined with mesh glove stimulation
|
This protocol includes 1 hour mirror therapy and 0.5 hour functional training in a session.
The treatment intensity is 1.5 hours/day, 5 days/week, for 4 weeks.
MT focuses on symmetrical bimanual movements and simultaneously observing the visual feedback of the unaffected upper extremity reflected by the mirror.
他の名前：
The MG is a two-channel electrical stimulator providing synchronous or reciprocal sensory stimulation with variant amplitudes.
他の名前：
|
|
アクティブコンパレータ：Controlled intervention
conventional interventions
|
Participants in this group receive a structured protocol based on occupational therapy such as neuro-developmental techniques and task-oriented approach
他の名前：
|
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 |
|---|---|---|
|
Fugl-Meyer Assessment (FMA)
時間枠：Baseline, change from baseline in FMA at 4 weeks, change from baseline in FMA at 16 weeks, change from baseline in FMA at 28 weeks
|
The upper-extremity subscale of the FMA contains 33 items to assess motor impairment.
Each item is scored on a 3-point ordinal scale (0-cannot perform, 1-performs partially, 2-performs fully and correctly).
The sub-score of a proximal shoulder/elbow (0-42) and a distal hand/wrist (0-24) will be also calculated to investigate the treatment effects on separate upper extremity elements.
|
Baseline, change from baseline in FMA at 4 weeks, change from baseline in FMA at 16 weeks, change from baseline in FMA at 28 weeks
|
|
Wolf Motor Function Test (WMFT)
時間枠：Baseline, change from baseline in WMFT at 4 weeks, change from baseline in WMFT at 16 weeks, change from baseline in WMFT at 28 weeks
|
|
Baseline, change from baseline in WMFT at 4 weeks, change from baseline in WMFT at 16 weeks, change from baseline in WMFT at 28 weeks
|
|
Accelerometers
時間枠：Baseline, change from baseline in accelerometers at 4 weeks, change from baseline in accelerometers at 16 weeks, change from baseline in accelerometers at 28 weeks
|
The accelerometers are used to provide a direct and objective measure of the amount of the impaired arm movement outside the laboratory.
Acceleration is sampled at 10 Hz and summed over a user- specified epoch.
The recording epoch in this study is 2 seconds; recording capacity is approximately 72 hours.
A "threshold-filter" will be applied to the raw recordings to obtain an accurate measure of the duration of arm movement.
|
Baseline, change from baseline in accelerometers at 4 weeks, change from baseline in accelerometers at 16 weeks, change from baseline in accelerometers at 28 weeks
|
|
revised Nottingham Sensory Assessment (rNSA)
時間枠：Baseline, change from baseline in rNSA at 4 weeks, change from baseline in rNSA at 16 weeks, change from baseline in rNSA at 28 weeks
|
The rNSA examines the sensory function of the affected arm and includes tactile sensation (0=Absent, 1=Impaired, 2=Normal), proprioception (0=Absent, 1=Appreciation of movement sense, 2=Direction of movement sense, 3=Joint position sense), and stereognosis (0=Absent, 1=Impaired, 2=Normal) subtests.
|
Baseline, change from baseline in rNSA at 4 weeks, change from baseline in rNSA at 16 weeks, change from baseline in rNSA at 28 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Kinematic analyses
時間枠：Baseline, change from baseline in kinematic parameters at 4 weeks
|
A 7-camera motion-analysis system (VICON MX, Oxford Metrics Inc., Oxford, UK) was used.
The variables of reaction time (second), movement time (second), total displacement (mm), peak velocity (mm/second), percentage of peak velocity, joint recruitments (degree), and maximum shoulder and elbow cross-correlation were collected.
|
Baseline, change from baseline in kinematic parameters at 4 weeks
|
|
Motor Activity Log (MAL)
時間枠：Baseline, change from baseline in MAL at 4 weeks, change from baseline in MAL at 16 weeks, change from baseline in MAL at 28 weeks
|
The MAL is a semi-structured interview of patients to assess the amount of use (AOU) and quality of movement (QOM) of the affected upper extremity in 30 important daily activities using a 6-point ordinal scale.
Higher scores indicate superior amount and quality of use in affected upper extremity.
|
Baseline, change from baseline in MAL at 4 weeks, change from baseline in MAL at 16 weeks, change from baseline in MAL at 28 weeks
|
|
Semmes-Weinstein monofilaments
時間枠：Baseline, change from baseline in Semmes-Weistein monofilaments at 4 weeks, change from baseline in Semmes-Weistein monofilaments at 16 weeks, change from baseline in Semmes-Weistein monofilaments at 28 weeks
|
The Semmes-Weinstein monofilaments is used for measuring diminishing and returning cutaneous sensation.A nylon 'string' is specifically calibrated in stiffness to represent a baseline level of sensation that can be considered 'the line' between having neuropathy and having normal sensation.
|
Baseline, change from baseline in Semmes-Weistein monofilaments at 4 weeks, change from baseline in Semmes-Weistein monofilaments at 16 weeks, change from baseline in Semmes-Weistein monofilaments at 28 weeks
|
|
Functional Independence Measure (FIM)
時間枠：Baseline, change from baseline in FIM at 4 weeks, change from baseline in FIM at 16 weeks, change from baseline in FIM at 28 weeks
|
The FIM consists of 18 items grouped into 6 subscales.
Each item is rated from 1 to 7 (max.
score 126) based on the required level of assistance to perform the tasks.
|
Baseline, change from baseline in FIM at 4 weeks, change from baseline in FIM at 16 weeks, change from baseline in FIM at 28 weeks
|
|
Stroke Impact Scale version 3.0 (SIS 3.0)
時間枠：Baseline, change from baseline in SIS at 4 weeks, change from baseline in SIS at 16 weeks, change from baseline in SIS at 28 weeks
|
The SIS is a stroke-specific instrument of health related quality of life and contains 59 items measuring 8 domains.
Items are rated on a 5- point Likert scale with lower scores indicate greater difficulty in task completion during the past week.
Aggregate scores, ranges from 0 to 100, are generated for each domain.
|
Baseline, change from baseline in SIS at 4 weeks, change from baseline in SIS at 16 weeks, change from baseline in SIS at 28 weeks
|
|
8-OHdG
時間枠：Baseline, change from baseline in 8-OHDG at 4 weeks, change from baseline in 8-OHDG at 16 weeks, change from baseline in 8-OHDG at 28 weeks
|
Urinary 8-OHdG is a stable and integral biomarker of oxidative DNA damage.About 10 mL to 15 mL urine samples of the patients will be collected in the centrifugal tubes before and after rehabilitation interventions.
The samples will be transported with dry ice under 4°C and preserved in a -80°C refrigerator before analysis.
A highly sensitive and selective method, using isotope- dilution liquid chromatography with tandem mass spectrometry (LC/MS/MS), will be used to determine the urinary 8-OHdG levels.
|
Baseline, change from baseline in 8-OHDG at 4 weeks, change from baseline in 8-OHDG at 16 weeks, change from baseline in 8-OHDG at 28 weeks
|
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。
捜査官
- 主任研究者：Keh-chung Lin, ScD、School of Occupational Therapy, College of Medicine, National Taiwan University
- 主任研究者：Tsan-hon Liou, PhD、Shuang-Ho Hospital, Taipei Medical University
- 主任研究者：Ching-yi Wu, ScD、Department of Occupational Therapy, College of Medicine, Chang Gung University
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
2010年9月1日
一次修了 (実際)
2014年5月1日
研究の完了 (実際)
2014年5月1日
試験登録日
最初に提出
2012年7月27日
QC基準を満たした最初の提出物
2012年8月2日
最初の投稿 (見積もり)
2012年8月3日
学習記録の更新
投稿された最後の更新 (見積もり)
2015年11月5日
QC基準を満たした最後の更新が送信されました
2015年11月3日
最終確認日
2012年11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。