Home-based -Virtual Reality Intervention for Stroke Rehabilitation (Home-VR)
Virtual Reality Intervention for Stroke Rehabilitation - Home Based (Stage 2)
On-going rehabilitation is needed to maintain and improve the weaker upper extremity following stroke. Community rehabilitation programs for stroke individuals in the chronic stage are often difficult to be implement. Consequently, many individuals remain without structured interventional programs. Self-training programs, where individuals can independently continue to exercise at home, might answer this challenge. However, since exercising alone is boring and not motivating, individuals often stop the prescribed exercises and remain inactive. The use of video-games for self-training might answer this challenge.
Therefore, the investigators aimed to assess the feasibility of using video-games for self-training after stroke. Specifically the investigators aim to compare the (1) training time, (2) satisfaction and (3) effectiveness of a self-training program using video-games compared to a traditional self-training program.
調査の概要
詳細な説明
This is a single-blind randomized controlled trial with four assessments; two before and two following the 5-week self training intervention.
Individuals are requested to perform the self training (video-games or traditional exercises) 60 minutes a day for 5 weeks.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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-
-
Ramat Gan、イスラエル
- Sheba medical center
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- 6 to 36 months after stroke onset
- lived in the community with family or a caregiver
- mild to moderate weakness the affected upper extremity
- without significant cognitive deficit
- able to walk at least 10-meters (with or without assistance).
Exclusion Criteria:
- Other neurological conditions
- Epilepsy
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：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：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：self-training using video-games
Participants will receive a video-game console and will be asked to play video-games for one hour a day X 6 days a week for 5 weeks.
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Individuals will receive a video-game console and will be taught how to play the games. They will be requested to play 60 minutes a day for 5 weeks. |
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アクティブコンパレータ：traditional self-training
Participants will receive a manual and kit of a traditional self-training program and will be asked to perform the program one hour a day X 6 days a week for 5 weeks.
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Individuals will receive a manual and equipment and will be taught how to perform the exercises.
They will be requested to perform the exercises 60 minutes a day for 5 weeks.
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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 |
|---|---|---|
|
self-training time
時間枠：week 9
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Self-training time for the 5-week program as documented on a daily log sheet by the participants in both self-training programs.
The mean weekly training hours per week will also be calculated.
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week 9
|
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Change in Action Research Arm Test
時間枠：week 0, week 4, week 9, week 13
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change in functional ability of the weaker upper extremity
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week 0, week 4, week 9, week 13
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Box and Block Test
時間枠：week 0, week 4, week 9, week 13
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Change in dexterity of the weaker upper extremity as assessed by the Box and Block Test
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week 0, week 4, week 9, week 13
|
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Change in The Functional Reach Test
時間枠：week 4, week 9, week 13
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Change in standing balance
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week 4, week 9, week 13
|
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Daily enjoyment from the self-training
時間枠：week 9
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For each daily session participants rated their perceived enjoyment (1-5 points).
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week 9
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Change in the Motor Activity Log (MAL)
時間枠：week 0, week 4, week 9, week 13
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Change in daily use of the weaker upper extremity by using the MAL.
This self-report questionnaire generates two seperate scores ranging from 0 to 5, regarding the amount and quality of the weaker upper extremity
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week 0, week 4, week 9, week 13
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Daily exertion from the self-training
時間枠：week 9
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For each daily session participants rated their perceived exertion (6-20 on the Borg scale).
A mean score will be calculated per week.
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week 9
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Satisfaction from the self-training program
時間枠：week 9
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Satisfaction from the 5-week program and their perceived benefit from the program for improving their weaker upper extremity and balance on a 5-point Likert scale from "not at all" to "very much".
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week 9
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協力者と研究者
スポンサー
捜査官
- スタディディレクター：Debbie Rand, OT, PhD、Tel Aviv University
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
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 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
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
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。