Home-based -Virtual Reality Intervention for Stroke Rehabilitation

NCT ID: NCT02393170

Last Updated: 2016-02-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2015-08-31

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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

self-training using video-games

Intervention Type: OTHER

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

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.

Group Type: ACTIVE_COMPARATOR

traditional self-training

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

European Commission

OTHER

Sponsor Role: collaborator

Sheba Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Debbie Rand, OT, PhD

Role: STUDY_DIRECTOR

Tel Aviv University

Locations

Sheba Medical Center

Ramat Gan, , Israel

Countries

Israel

Other Identifiers

SHEBA-14-1764-HW-CTIL

Identifier Type: -

Identifier Source: org_study_id