Home-based -Virtual Reality Intervention for Stroke Rehabilitation (Home-VR)
Primary Purpose
Stroke
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
self-training using video-games
traditional self-training
Sponsored by
About this trial
This is an interventional treatment trial for Stroke
Eligibility Criteria
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
Sites / Locations
- Sheba Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
self-training using video-games
traditional self-training
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
self-training time
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.
Change in Action Research Arm Test
change in functional ability of the weaker upper extremity
Secondary Outcome Measures
Change in Box and Block Test
Change in dexterity of the weaker upper extremity as assessed by the Box and Block Test
Change in The Functional Reach Test
Change in standing balance
Daily enjoyment from the self-training
For each daily session participants rated their perceived enjoyment (1-5 points).
Change in the Motor Activity Log (MAL)
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
Daily exertion from the self-training
For each daily session participants rated their perceived exertion (6-20 on the Borg scale). A mean score will be calculated per week.
Satisfaction from the self-training program
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".
Full Information
NCT ID
NCT02393170
First Posted
February 22, 2015
Last Updated
February 12, 2016
Sponsor
Sheba Medical Center
Collaborators
European Commission
1. Study Identification
Unique Protocol Identification Number
NCT02393170
Brief Title
Home-based -Virtual Reality Intervention for Stroke Rehabilitation
Acronym
Home-VR
Official Title
Virtual Reality Intervention for Stroke Rehabilitation - Home Based (Stage 2)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sheba Medical Center
Collaborators
European Commission
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
self-training using video-games
Arm Type
Experimental
Arm Description
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.
Arm Title
traditional self-training
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
self-training using video-games
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
traditional self-training
Intervention Description
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.
Primary Outcome Measure Information:
Title
self-training time
Description
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.
Time Frame
week 9
Title
Change in Action Research Arm Test
Description
change in functional ability of the weaker upper extremity
Time Frame
week 0, week 4, week 9, week 13
Secondary Outcome Measure Information:
Title
Change in Box and Block Test
Description
Change in dexterity of the weaker upper extremity as assessed by the Box and Block Test
Time Frame
week 0, week 4, week 9, week 13
Title
Change in The Functional Reach Test
Description
Change in standing balance
Time Frame
week 4, week 9, week 13
Title
Daily enjoyment from the self-training
Description
For each daily session participants rated their perceived enjoyment (1-5 points).
Time Frame
week 9
Title
Change in the Motor Activity Log (MAL)
Description
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
Time Frame
week 0, week 4, week 9, week 13
Title
Daily exertion from the self-training
Description
For each daily session participants rated their perceived exertion (6-20 on the Borg scale). A mean score will be calculated per week.
Time Frame
week 9
Title
Satisfaction from the self-training program
Description
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".
Time Frame
week 9
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Debbie Rand, OT, PhD
Organizational Affiliation
Tel Aviv University
Official's Role
Study Director
Facility Information:
Facility Name
Sheba Medical Center
City
Ramat Gan
Country
Israel
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Home-based -Virtual Reality Intervention for Stroke Rehabilitation
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