Home-based -Virtual Reality Intervention for Stroke Rehabilitation

Stroke Clinical Trial

— Home-VR  

Official title:

Virtual Reality Intervention for Stroke Rehabilitation - Home Based (Stage 2)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02393170
• Other study ID #: SHEBA-14-1764-HW-CTIL
• Status: Completed
• Phase: N/A
• First received: February 22, 2015
• Last updated: February 12, 2016
• Start date: November 2014
• Est. completion date: August 2015

Study information

• Verified date: February 2016
• Source: Sheba Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: August 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• self-training using video-games
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.
• traditional self-training
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.

Locations

Country	Name	City	State
Israel	Sheba Medical Center	Ramat Gan

Sponsors (2)

Lead Sponsor	Collaborator
Sheba Medical Center	European Commission

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	week 9	No
Primary	Change in Action Research Arm Test	change in functional ability of the weaker upper extremity	week 0, week 4, week 9, week 13	No
Secondary	Change in Box and Block Test	Change in dexterity of the weaker upper extremity as assessed by the Box and Block Test	week 0, week 4, week 9, week 13	No
Secondary	Change in The Functional Reach Test	Change in standing balance	week 4, week 9, week 13	No
Secondary	Daily enjoyment from the self-training	For each daily session participants rated their perceived enjoyment (1-5 points).	week 9	No
Secondary	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	week 0, week 4, week 9, week 13	No
Secondary	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.	week 9	No
Secondary	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".	week 9	No