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.
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Ramat Gan, 이스라엘
- Sheba medical center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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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활성 비교기: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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self-training time
기간: 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
기간: 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
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Box and Block Test
기간: 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
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
수사관
- 연구 책임자: Debbie Rand, OT, PhD, Tel Aviv University
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .