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.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Other: self-training using video-games; Other: traditional self-training

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.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Ramat Gan, Israel
    • Sheba Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Active Comparator: 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.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Change in Action Research Arm Test	change in functional ability of the weaker upper extremity	week 0, week 4, week 9, week 13

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Change in The Functional Reach Test	Change in standing balance	week 4, week 9, week 13
Daily enjoyment from the self-training	For each daily session participants rated their perceived enjoyment (1-5 points).	week 9
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
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
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

Collaborators and Investigators

• Sponsor: Sheba Medical Center
• Collaborators: European Commission
• Investigators: Study Director: Debbie Rand, OT, PhD, Tel Aviv University

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: February 22, 2015
• First Submitted That Met QC Criteria: March 18, 2015
• First Posted (Estimate): March 19, 2015

Study Record Updates

• Last Update Posted (Estimate): February 15, 2016
• Last Update Submitted That Met QC Criteria: February 12, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: SHEBA-14-1764-HW-CTIL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO