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Completed

NCT Number: NCT02393170

Home-based -Virtual Reality Intervention for Stroke Rehabilitation

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sheba Medical Center

Ramat Gan, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

self-training using video-games

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

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.

Primary outcomes

  1. self-training time

    Time frame: week 9

    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.

  2. Change in Action Research Arm Test

    Time frame: week 0, week 4, week 9, week 13

    change in functional ability of the weaker upper extremity

Secondary outcomes

  1. Change in Box and Block Test

    Time frame: week 0, week 4, week 9, week 13

    Change in dexterity of the weaker upper extremity as assessed by the Box and Block Test

  2. Change in The Functional Reach Test

    Time frame: week 4, week 9, week 13

    Change in standing balance

  3. Daily enjoyment from the self-training

    Time frame: week 9

    For each daily session participants rated their perceived enjoyment (1-5 points).

  4. Change in the Motor Activity Log (MAL)

    Time frame: week 0, week 4, week 9, week 13

    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

  5. Daily exertion from the self-training

    Time frame: week 9

    For each daily session participants rated their perceived exertion (6-20 on the Borg scale). A mean score will be calculated per week.

  6. Satisfaction from the self-training program

    Time frame: week 9

    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".

Sponsors and collaborators

Lead sponsor

Sheba Medical Center

Other Gov

Collaborators

  • European Commission

Registry information

Official study title

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

Acronym: Home-VR

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Mar 19, 2015
Registry last updated
Feb 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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