Assisted Movement Neuro-rehabilitation: VA Multi-site Clinical Trial
2014年1月3日 更新者：US Department of Veterans Affairs
The purpose of this study is to compare the effectiveness of a lower-dose and higher-dose therapy program for persons recovering from a recent stroke using mechanically-assisted upper limb movement with a device called MIME.
A control group receives additional occupational therapy without the use of MIME.
調査の概要
詳細な説明
This study continues our investigation of the optimal timing, intensity, and duration of robot-assisted training to improve motor performance in patients with hemiplegia following stroke.
These hypotheses will be tested: 1) subjects receiving robot-assisted upper limb therapy with MIME in the initial phase of recovery from stroke experience greater functional gains than a control group receiving additional conventional therapy of equal intensity and duration, 2) robot-assisted therapy results in a dose-dependent response, and 3) robot-assisted therapy promotes greater control of movement, greater recovery of strength, and greater reduction of co-contraction than the control intervention.
Research Plan - A multi-site clinical trial is in progress at the Houston VA Medical Center (VAMC), the VA Greater Los Angeles Health Care System (GLAHCS), the VA Palo Alto Rehabilitation Research and Development Center (RR&DC), and the Central Texas Veterans Health Care System (CTVHCS).
CTVHCS serves as the coordinating site.
The RR&DC provides training and technical assistance for the other sites.
Methods - Subjects with hemiparesis due to a stroke are randomly assigned to 3 groups.
Group 1 receives 1 hour/day of robot-assisted upper limb therapy in addition to usual physical and occupational therapy.
Group 2 receives a total of 2 hours/day of robot-assisted therapy.
Group 3 receives 1 hour/day of additional upper limb therapy that includes exposure to, but no manipulation by the robot.
Outcome measures include assessment of strength, motor control, functional status, and patient satisfaction at intake, discharge, 6 and 12 months.
研究の種類
介入
入学 (実際)
71
段階
- フェーズ 3
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
-
-
California
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Palo Alto、California、アメリカ、94304-1290
- VA Palo Alto Health Care System
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West Los Angeles、California、アメリカ、90073
- VA Greater Los Angeles Healthcare System, West LA
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Texas
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Houston、Texas、アメリカ、77030
- Michael E. DeBakey VA Medical Center (152)
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Temple、Texas、アメリカ、76504
- Central Texas Veterans Health Care System
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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
21年歳以上 (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:
- Over 21 years of age, weakness due to a recent stroke or other brain injury, and receiving rehabilitation. Subjects are inpatients at one of the participating VA hospitals.
Exclusion Criteria:
Unable to follow instructions; medically unstable.
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 |
|---|---|
|
実験的：Robot-Low
low-dose mechanically-assisted upper limb therapy
|
1 hour/day of robot-assisted upper limb exercise therapy in addition to usual physical and occupational therapy
|
|
実験的：Robot-High
high-dose mechanically-assisted upper limb therapy
|
2 hours/day of robot-assisted therapy in addition to usual physical and occupational therapy
|
|
アクティブコンパレータ：Control
additional traditional therapy
|
1 hour/day of additional upper limb therapy that includes exposure to, but no manipulation by the robot
|
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 Score Change Immediately Following Study Intervention.
時間枠：After study intervention (on completion of the maximum planned number of sessions for their group or discharge from inpatient rehabilitation, whichever came first) compared to baseline at study enrollment between 7 and 21 days post-stroke.
|
Change in Fugl-Meyer Assessment (FMA) score.
The FMA evaluates motor function, sensation, balance, and joint function in hemiplegic patients and provides a cumulative numerical score.
It is widely used to evaluate changes in function over time in clinical care and therapeutic trials following stroke.
Five domains can be assessed, including motor function (upper and lower limbs); sensory function; balance; joint range of motion; and joint pain.
Items within each domain are scored on a 3-point ordinal scale: 0 = cannot perform; 1 = performs partially; and 2 = performs fully.
Subscales can be administered without the using the full test.
For the upper limb motor function subscale used in this clinical trial, 33 items were evaluated, each rated on a 3-point scale (0-2), then summed for a maximum possible score of 66.
A greater increase in the score represents a greater improvement in upper limb motor function.
|
After study intervention (on completion of the maximum planned number of sessions for their group or discharge from inpatient rehabilitation, whichever came first) compared to baseline at study enrollment between 7 and 21 days post-stroke.
|
|
Fugl-Meyer Score Change at 6 Months
時間枠：FMA at 6 months from study enrollment compared to baseline FMA performed prior to study intervention, which began between 7 and 21 days post-stroke.
|
Change in Fugl-Meyer score at 6-months from study enrollment compared to baseline.
Maximum score = 66.
|
FMA at 6 months from study enrollment compared to baseline FMA performed prior to study intervention, which began between 7 and 21 days post-stroke.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in FIM Score Immediately Following Study Intervention.
時間枠：After study intervention (on completion of the maximum planned number of sessions for each group or discharge from inpatient rehabilitation, whichever came first) compared to baseline at study enrollment between 7 and 21 days post-stroke.
|
Change in the upper limb portion of the Functional Independence Measure (FIM) was assessed to determine treatment impact on independence in activities of daily living (ADL).
The FIM indicates the level of disability based on how much assistance is required for an individual to carry out ADL.
It can be used to assess13 motor and 5 cognitive tasks, each rated on a 7 point ordinal scale (0 = total assistance or complete dependence; 7 = complete independence in the task).
Tasks include For this study, a subset of 9 tasks involving the upper limbs was used (maximum score = 63).
A greater change represents a greater improvement in independence carrying out tasks requiring functional use of the upper limbs.
|
After study intervention (on completion of the maximum planned number of sessions for each group or discharge from inpatient rehabilitation, whichever came first) compared to baseline at study enrollment between 7 and 21 days post-stroke.
|
|
Change in FIM Score at 6-months
時間枠：Change in FIM score at 6-months from study enrollment compared to baseline FIM prior to study intervention, which began between 7 and 21 days post-stroke.
|
Change in FIM score at 6-months from study enrollment compared to baseline. Maximum score = 63 . |
Change in FIM score at 6-months from study enrollment compared to baseline FIM prior to study intervention, which began between 7 and 21 days post-stroke.
|
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：Charles Burgar, MD、Central Texas Veterans Health Care System
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
2002年1月1日
一次修了 (実際)
2008年7月1日
研究の完了 (実際)
2008年7月1日
試験登録日
最初に提出
2005年9月14日
QC基準を満たした最初の提出物
2005年9月14日
最初の投稿 (見積もり)
2005年9月22日
学習記録の更新
投稿された最後の更新 (見積もり)
2014年2月17日
QC基準を満たした最後の更新が送信されました
2014年1月3日
最終確認日
2014年1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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