このページは自動翻訳されたものであり、翻訳の正確性は保証されていません。を参照してください。 英語版 ソーステキスト用。

Effects of RR and MT on Patient With Stroke

2012年7月29日 更新者：National Taiwan University Hospital

Randomized Trials of Robotic Rehabilitation, Mirror Therapy, and Dose-Matched Control Intervention for Upper-Limb Rehabilitation in Patients With Chronic Stroke: Comparative Efficacy and Clinimetric Study

The purpose of this proposal is 1) to compare the relative effects of the robotic rehabilitation (RR), mirror therapy (MT), and conventional intervention (CI), 2) to compare the effects of the combined therapy of the RR-Functional Electrical Stimulation (FES) and the RR-Placebo Intervention (PI), and 3) to identify the clinical predictors that will potentially influence the functional outcomes after interventions.

調査の概要

状態

わからない

条件

介入・治療

詳細な説明

Motor deficit of upper extremity is one of the prominent problems in patients with stroke. Looking for effective and efficient treatments to improve affected UE function is of great importance in the field of rehabilitation. Two emerging movement therapies in stroke rehabilitation are robotic rehabilitation (RR) and mirror therapy (MT). Scientific evidence for comparative effectiveness research of RR versus MT versus CI on functional outcomes (e.g., motor, muscle, sensory, and daily functions) in stroke patients is limited. In addition, studies showed FES induced some improvements in individual movements at the shoulder, elbow, wrist, and fingers or in muscle strength in patients with moderate-to-severe paresis. The combination therapy of the FES and training protocols may increase the benefits of standard rehabilitative treatments and may also facilitate motor learning. However, the combined training effects of the RR and FES on stroke patients have not been well studies in a larger sample yet. Specific objectives of this proposed research are as follows: First, The investigators will compare the efficacy of the RR, MT, and conventional rehabilitation. Secondly, the investigators will compare the efficacy of the RR-FES versus RR-PI on outcome measures. Thirdly, the investigators will identify the clinical predictors that will potentially influence the functional outcomes after interventions.

研究の種類

介入

入学 (予想される)

100

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

  • 台湾
      • Taipei City、台湾
        • 募集
        • National Taiwan University Hospital
        • コンタクト：
        • 主任研究者：
          • Keh-chung Lin, ScD

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

40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:

  • Willing to provide the written informed consent
  • More than 6 months onset of unilateral stroke
  • An initial 25-56 or 18-50 scores on the UE subtest of the FMA
  • Sufficient cognitive ability (Mini Mental State Examination ≧ 24 points)
  • Without upper limb fracture within 3 months

Exclusion Criteria:

  • Recurrent of stroke or seizure episode during the intervention
  • Occurence of serious or continuous pain on affected upper-extremity
  • History of other neurological disease or severe orthopaedic condition

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：Robotic Rehabilitation with FES
Robotic rehabilitation combined Functional Electrical Stimulation (FES)
行動：FESによるロボットリハビリテーション
この組み合わせ RR-FES 治療には、患者が RR と同時に FES を受けることを除いて、RR レジメンと同じプロトコルが含まれます。
他の名前：
  • RR-Functional Electrical Stimulation
  • RR combined Functional Electrical Stimulation
  • RR-FES
実験的：Mirror Therapy
Mirror Therapy (MT)
行動：ミラーセラピー
このプロトコルには、1回のセッションで1時間のミラーセラピーと0.5時間のファンクショナルトレーニングが含まれます。 治療強度は、1 日 1.5 時間、週 5 日、4 週間です。 MT は左右対称の両手の動きに焦点を当て、同時に、影響を受けていない上肢によって反射されるミラーの視覚的フィードバックを観察します。
他の名前：
  • MT
アクティブコンパレータ：Conventional Rehabilitation
Conventional Rehabilitation (CR) mainly focuses on occupational therapy training
行動：従来のリハビリテーション
このグループの参加者は、神経発達技術やタスク指向アプローチなどの作業療法に基づいた構造化されたプロトコルを受け取ります。 治療用量は、RR および MT グループに一致します。
他の名前：
  • CT
  • 対照治療
  • CR
実験的：Robotic Rehabilitation
Robotic Rehabilitation (RR)
行動：Robotic Rehabilitation
This protocol includes 5 to 10 min of warm-up, 1 hr of RR, and 15 to 20 min of functional activities training. The treatment intensity is 1.5 hours/day, 5days/week for 4 consecutive weeks. The RR session uses the robot-assisted arm trainer, Bi-Manu-Track (Reha-Stim Co., Berlin, Germany).
他の名前：
  • RT
  • RR
  • ロボット療法
プラセボコンパレーター：Robotic Rehabilitation with PI
Robotic rehabilitation with Placebo Intervention (RR-PI)
行動：Robotic Rehabilitation with PI
The RR-PI protocol is the same as the RR-FES protocol described above except that the surface electrodes are attached to the same target muscles on the affected UL but there is no output of electrical stimulation.
他の名前：
  • Robotic Rehabilitation-PI
  • RR with Placebo Intervention
  • RR-PI

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：Change from baseline in FMA at 4 weeks, change from baseline in FMA at 8 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).
Change from baseline in FMA at 4 weeks, change from baseline in FMA at 8 weeks, change from baseline in FMA at 16 weeks, change from baseline in FMA at 28 weeks
Modified Ashworth Scale (MAS)
時間枠：Change from baseline in MAS at 4 weeks, change from baseline in MAS at 8 weeks, change from baseline in MAS at 16 weeks, change from baseline in MAS at 28 weeks
The MAS is a 5-point ordinal scale to evaluate muscle tone of upper-extremity. Higher score indicates a more severe hypertonia.
Change from baseline in MAS at 4 weeks, change from baseline in MAS at 8 weeks, change from baseline in MAS at 16 weeks, change from baseline in MAS at 28 weeks
Functional independence measure (FIM)
時間枠：Change from baseline in FIM at 4 weeks, change from baseline in FIM at 8 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 measuring self-care, sphincter control, transfer, locomotion, communication, and social cognition ability. Each item is rated from 1 to 7 based on the required level of assistance to perform the tasks.
Change from baseline in FIM at 4 weeks, change from baseline in FIM at 8 weeks, change from baseline in FIM at 16 weeks, change from baseline in FIM at 28 weeks
Movement units (MU)
時間枠：Change from baseline in MU at 4 weeks
The parameter of movement units is collected by a 7-camera motion analysis system (VICON MX 3-D, Oxford Metrics Inc., Oxford, UK) from unilateral and bilateral reaching tasks of pressing the desk bell. One acceleration phase and one deceleration phase constitute a MU. The number of MU indicates the movement smoothness.
Change from baseline in MU at 4 weeks
Total displacement (TD)
時間枠：Change from baseline in TD at 4 weeks
The TD is collected by a 7-camera motion analysis system (VICON MX 3-D, Oxford Metrics Inc., Oxford, UK) from unilateral and bilateral reaching tasks of pressing the desk bell. TD refers to the path of a hand shifting in three-dimensional space and is a measurement of trajectory smoothness.
Change from baseline in TD at 4 weeks
Percentage of peak velocity (PPV)
時間枠：Change from baseline in PPV at 4 weeks
PPV is collected by a 7-camera motion analysis system (VICON MX 3-D, Oxford Metrics Inc., Oxford, UK) from unilateral and bilateral reaching tasks of pressing the desk bell. PPV indicates the percentage of acceleration phase among the whole movement process. It is an outcome measurement of pre-motor planning ability.
Change from baseline in PPV at 4 weeks
Reaction time (RT)
時間枠：Change from baseline in RT at 4 weeks
The reaction time is collected by a 7-camera motion analysis system (VICON MX 3-D, Oxford Metrics Inc., Oxford, UK) from unilateral and bilateral reaching tasks of pressing the desk bell. RT is the time required to prepare a motor response toward an external signal and indicates speed of motor planning.
Change from baseline in RT at 4 weeks
Action Research Arm Test (ARAT)
時間枠：Change from baseline in ARAT at 4 weeks, change from baseline in ARAT at 8 weeks, change from baseline in ARAT at 16 weeks, change from baseline in ARAT at 28 weeks
The ARAT assesses the ability to handle objects with 19 items divided into 4 subscales of grasp, grip, pinch, and gross movement by 4-level ordinal scale. Higher the score, better the performance.
Change from baseline in ARAT at 4 weeks, change from baseline in ARAT at 8 weeks, change from baseline in ARAT at 16 weeks, change from baseline in ARAT at 28 weeks
Medical Research Council scale (MRC)
時間枠：Change from baseline in MRC at 4 weeks, change from baseline in MRC at 8 weeks, change from baseline in MRC at 16 weeks, change from baseline in MRC at 28 weeks
The MRC scale assesses muscle power with scores ranging from 0 (no contraction) to 5 (normal power). The muscle strength of shoulder flexors/abductors, elbow flexors/extensors, wrist flexors/extensors, and finger extensors are graded.
Change from baseline in MRC at 4 weeks, change from baseline in MRC at 8 weeks, change from baseline in MRC at 16 weeks, change from baseline in MRC at 28 weeks
MYOTON-3
時間枠：Change from baseline in MYOTON-3 at 4 weeks, change from baseline in MYOTON-3 at 8 weeks, change from baseline in MYOTON-3 at 16 weeks, change from baseline in MYOTON-3 at 28 weeks
MYOTON-3 is used to assess muscle tone of the affected upper limb. There are three measurement parameters in the MYOTON-3: F - Frequency, Hz, characterizing muscle tone; D - Decrement, characterizing muscle elasticity; and S - Stiffness, N/m, characterizing muscle stiffness.
Change from baseline in MYOTON-3 at 4 weeks, change from baseline in MYOTON-3 at 8 weeks, change from baseline in MYOTON-3 at 16 weeks, change from baseline in MYOTON-3 at 28 weeks
Accelerometers
時間枠：Change from baseline in accelerometers at 4 weeks, change from baseline in accelerometers at 8 weeks, change from baseline in accelerometers at 16 weeks, change from baseline in accelerometers at 28 weeks
Accelerometers are used to provide a direct and objective measure of the amount of the impaired arm movement outside the laboratory. In this project, 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.
Change from baseline in accelerometers at 4 weeks, change from baseline in accelerometers at 8 weeks, change from baseline in accelerometers at 16 weeks, change from baseline in accelerometers at 28 weeks
Peak velocity (PV)
時間枠：Change from baseline in PV at 4 weeks
PPV is collected by a 7-camera motion analysis system (VICON MX 3-D, Oxford Metrics Inc., Oxford, UK) from unilateral and bilateral reaching tasks of pressing the desk bell. PV corresponds to the changeover from the acceleration to the deceleration phase and is related to the force produced.
Change from baseline in PV at 4 weeks
Trunk related Kinematic variables
時間枠：Change from baseline in trunk related kinematic variables at 4 weeks
The parameter of movement units is collected by a 7-camera motion analysis system (VICON MX 3-D, Oxford Metrics Inc., Oxford, UK) from unilateral and bilateral reaching tasks of pressing the desk bell. These parameters include trunk displacement, trunk flexion angular change, trunk-arm delay, shoulder flexion & trunk flexion correlation, and elbow extension & trunk flexion correlation. These variables indicate the degree of trunk compensatory movement and interjoint coordination.
Change from baseline in trunk related kinematic variables at 4 weeks

二次結果の測定

結果測定
メジャーの説明
時間枠
Motor Activity Log (MAL)
時間枠：Change from baseline in MAL at 4 weeks, change from baseline in MAL at 8 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.
Change from baseline in MAL at 4 weeks, change from baseline in MAL at 8 weeks, change from baseline in MAL at 16 weeks, change from baseline in MAL at 28 weeks
ABILHAND Questionnaire
時間枠：Change from baseline in ABILHAND at 4 weeks, change from baseline in ABILHAND at 8 weeks, change from baseline in ABILHAND at 16 weeks, change from baseline in ABILHAND at 28 weeks
The ABILHAND is an inventory of 56 manual activities measuring the patient's perceived difficulty in daily activities.
Change from baseline in ABILHAND at 4 weeks, change from baseline in ABILHAND at 8 weeks, change from baseline in ABILHAND at 16 weeks, change from baseline in ABILHAND at 28 weeks
Stroke Impact Scale Version 3.0 (SIS 3.0)
時間枠：Change from baseline in SIS at 4 weeks, change from baseline in SIS at 8 weeks, change from baseline in SIS at 16 weeks, change from baseline in SIS at 28 weeks
The SIS 3.0 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.
Change from baseline in SIS at 4 weeks, change from baseline in SIS at 8 weeks, change from baseline in SIS at 16 weeks, change from baseline in SIS at 28 weeks
Nottingham Extended Activities of Daily Living Scale (NEADL)
時間枠：Change from baseline in NEADL at 4 weeks, change from baseline in NEADL at 8 weeks, change from baseline in NEADL at 16 weeks, change from baseline in NEADL at 28 weeks
The NEADL consists of 22 activity items, scoring on the basis of the required level of assistance. The range of total score is 0-66, and higher score representing better function.
Change from baseline in NEADL at 4 weeks, change from baseline in NEADL at 8 weeks, change from baseline in NEADL at 16 weeks, change from baseline in NEADL at 28 weeks
revised Nottingham Sensory Assessment (rNSA)
時間枠：Change from baseline in rNSA at 4 weeks, change from baseline in rNSA at 8 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, proprioception, and stereognosis subtests.
Change from baseline in rNSA at 4 weeks, change from baseline in rNSA at 8 weeks, change from baseline in rNSA at 16 weeks, change from baseline in rNSA at 28 weeks
Fugl-Meyer Assessment-Sensory (FMA-S)
時間枠：Change from baseline in FMA-S at 4 weeks, change from baseline in FMA-S at 8 weeks, change from baseline in FMA-S at 16 weeks, change from baseline in FMA-S at 28 weeks
The FMA-S contains 12 three-point items, four for light touch and eight for position sense. The total score ranges from 0 to 24. The sensation for light touch will be estimated subjectively. The patient will be asked whether he or she feels that light touches on both arms and the palmar surface of the hands give the same qualitative and quantitative impressions. The position sense of the joints will involve tests for interphalangeal joint of the thumb, the wrist, the elbow, and the shoulder joint
Change from baseline in FMA-S at 4 weeks, change from baseline in FMA-S at 8 weeks, change from baseline in FMA-S at 16 weeks, change from baseline in FMA-S at 28 weeks
8-OHdG: A Biomarker of Oxidative Stress
時間枠：Change from baseline in 8-OHdG at 4 weeks, change from baseline in 8-OHdG at 8 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 are collected in the centrifugal tubes before and after rehabilitation interventions. The samples is 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), is used to determine the urinary 8-OHdG levels.
Change from baseline in 8-OHdG at 4 weeks, change from baseline in 8-OHdG at 8 weeks, change from baseline in 8-OHdG at 16 weeks, change from baseline in 8-OHdG at 28 weeks
Multidimensional Fatigue Symptom Inventory (MFSI)
時間枠：Change from baseline in MFSI at 4 weeks, change from baseline in MFSI at 8 weeks, change from baseline in MFSI at 16 weeks, change from baseline in MFSI at 28 weeks
The general subscale of the MFSI is used to measure general fatigue of the patients. It includes 6 items with a total score ranging from 0 (not at all) to 24 (extremely).
Change from baseline in MFSI at 4 weeks, change from baseline in MFSI at 8 weeks, change from baseline in MFSI at 16 weeks, change from baseline in MFSI 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。

スポンサー

National Taiwan University Hospital

捜査官

  • 主任研究者：Keh-chung Lin, ScD、School of Occupational Therapy, College of Medicine, National Taiwan 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。

一般刊行物

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

2011年8月1日

一次修了 (予想される)

2014年7月1日

研究の完了 (予想される)

2014年7月1日

試験登録日

最初に提出

2012年7月19日

QC基準を満たした最初の提出物

2012年7月29日

最初の投稿 (見積もり)

2012年8月1日

学習記録の更新

投稿された最後の更新 (見積もり)

2012年8月1日

QC基準を満たした最後の更新が送信されました

2012年7月29日

最終確認日

2012年7月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • 201012131RB

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。

購読する