In Home VR Therapy
Multi-user Virtual Training for Upper Extremity in the Home
Virtual reality is a video game in which a person and their real-time movements are represented on a screen in a virtual environment. This study will compare the use of multi-user virtual reality (VR) to single-user VR to determine if either provides superior engagement in upper extremity therapy and greater motivation to perform repetitive training.
Stroke survivors will participate in a longitudinal study in which they will have the opportunity to perform rehabilitative training with multi-user VR and single-user VR modes in their homes. They will use each mode for 2 weeks, completing 4 session per week, each session is 1 hour long. Upper extremity motor control, level of engagement, and active range of motion will be assessed at time points during the intervention period.
Subject evaluations will take place before the intervention, at the midpoint of intervention (between switching from multi-user to single-user modes, or vice versa), and at the end of the intervention.
The investigators hope to address two aims:
Aim 1: To determine if the use in-home multi-user virtual reality treatment results in greater engagement in therapy compared with in-home single user virtual reality treatment.
Aim 2: To determine if in-home virtual reality treatment results in greater practice
The investigators hypothesize that stroke survivors will be more engaged in therapy when training with the multi-user VR system and this will translate into greater practice.
調査の概要
状態
条件
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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Illinois
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Chicago、Illinois、アメリカ、60601
- Rehabilitation Institute of Chicago
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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:
- Are between the ages of 21 and 80
- Experienced a single stroke at least 6 months prior to enrollment
- Have moderate arm impairment as indicated by a score between 4 and 6 on the Chedoke-McMaster Stroke Assessment, arm subscale
- Live within 20 miles of the Rehabilitation Institute of Chicago (as study personnel will need to travel to their home)
Exclusion Criteria:
- Other neurological, neuromuscular, or orthopedic disease
- Pain in the upper extremity with movements required in the treatment
- Contracture that limits use of the VR system
- Vision problems which would preclude the ability to use the VR system
- Cognitive or language deficits that would prevent them from understanding the tasks
- Concurrent enrollment in another intervention study involving the affected arm or hand
- Botox injection in the arm within the previous 6 months
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：デバイスの実現可能性
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Single-User Mode first, Multi-User Mode second
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Virtual Reality games with the user as the only person required for participation
他の名前：
Virtual reality games in which more than one user is required for participation.
Users interact in the virtual environment.
他の名前：
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実験的：Multi-User Mode first, Single-User Mode second
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Virtual Reality games with the user as the only person required for participation
他の名前：
Virtual reality games in which more than one user is required for participation.
Users interact in the virtual environment.
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 |
|---|---|---|
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Hand displacement during each session
時間枠：Distance hand moves on average per session during each 2-week treatment phase (each subject will complete 2, 2-week phases of treatment. One 2-week phase being the Single-user mode and the other 2-week phase being the Multi-user mode)
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total distance hand moves during all therapy sessions divided by the number of sessions in which a subject participates.
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Distance hand moves on average per session during each 2-week treatment phase (each subject will complete 2, 2-week phases of treatment. One 2-week phase being the Single-user mode and the other 2-week phase being the Multi-user mode)
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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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Therapy mode amount of use
時間枠：2 week treatment phase
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Total amount of time subject spends in their assigned therapy mode during the 2-week treatment phase.
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2 week treatment phase
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Change in Active Range of Motion
時間枠：First measure taken at baseline, then also at the end of the first 2-week treatment phase and finally at the end of the second 2-week treatment phase.
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Change from baseline in angle of upper extremity movement (shoulder and elbow)
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First measure taken at baseline, then also at the end of the first 2-week treatment phase and finally at the end of the second 2-week treatment phase.
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Comparison of Intrinsic Motivation Inventory Score between therapy modes
時間枠：First measure taken at the end of the first 2-week treatment phase; Second measure taken at the end of the second 2-week treatment phase.
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Difference in Intrinsic Motivation Inventory score between single-user and multi-user modes
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First measure taken at the end of the first 2-week treatment phase; Second measure taken at the end of the second 2-week treatment phase.
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協力者と研究者
スポンサー
捜査官
- 主任研究者：James Patton, PhD、Shirley Ryan Abilitylab
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
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 (実際)
学習記録の更新
投稿された最後の更新 (実際)
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。