NCT02393170

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Nov 2014

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 22, 2015

Completed
25 days until next milestone

First Posted

Study publicly available on registry

March 19, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

February 15, 2016

Status Verified

February 1, 2016

Enrollment Period

8 months

First QC Date

February 22, 2015

Last Update Submit

February 12, 2016

Conditions

Stroke

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (6)

  • Change in Box and Block Test

    week 0, week 4, week 9, week 13

  • Change in The Functional Reach Test

    week 4, week 9, week 13

  • Daily enjoyment from the self-training

    week 9

  • Change in the Motor Activity Log (MAL)

    week 0, week 4, week 9, week 13

  • Daily exertion from the self-training

    week 9

  • +1 more secondary outcomes

Study Arms (2)

self-training using video-games

EXPERIMENTAL

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

traditional self-training

ACTIVE COMPARATOR

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

Interventions

self-training using video-gamesOTHER

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.

self-training using video-games
traditional self-trainingOTHER

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.

traditional self-training

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • Other neurological conditions
  • Epilepsy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheba Medical Center

Ramat Gan, Israel

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Debbie Rand, OT, PhD

    Tel Aviv University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2015

First Posted

March 19, 2015

Study Start

November 1, 2014

Primary Completion

July 1, 2015

Study Completion

August 1, 2015

Last Updated

February 15, 2016

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)