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The Jintronix Interactive System for Upper Extremity Rehabilitation Training Post Stroke

NCT ID: NCT03759145

Last Updated: 2018-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2016-01-31

Brief Summary

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Stroke is a leading cause of death and disability worldwide.Hemiplegia, weakness of one side of the body, is a common consequence of stroke that can lead to significant functional impairments. Loss of arm function occurs in up to 85% of stroke survivors. The impact of arm-related limitations on activities of daily living, leisure activities or work is significant as the arm plays a central role in a person's life from the ability to perform basic activities of daily life to carrying out family and social roles. Guidelines indicate that rehabilitation can improve upper extremity (UE) motor control and functional status post stroke. Virtual reality (VR) and computer games are recent technologies that, as they become more accessible and affordable,are increasingly being used in rehabilitation to allow patients to engage in repetitive practice of specific tasks. A number of published reviews and meta-analyses have examined the use of VR and video games for post-stroke rehabilitation, focusing on or including UE rehabilitation. The authors agree that there is limited but promising findings that VR and video-games, when combined with traditional rehabilitation, have a positive impact on recovery post-stroke.

Detailed Description

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The goal of the study is to assess the feasibility, safety, and acceptability of the Jintronix system, as well as provide preliminary evidence regarding the clinical efficacy for post-stroke rehabilitation.This is a pilot parallel randomised single-blinded controlled trial, with patients who have had a stroke randomly allocated to one of two groups: (1) usual rehabilitation services and additional training with Jintronix system (treatment group) or (2) usual rehabilitation services only (control group).

Conditions

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Stroke

Keywords

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virtual reality exergame stroke rehabilitation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Intervention arm, usual rehabilitation + Jintronix exergame

On top of the usual out-patient rehabilitation sessions planned for the participant, participants attend sessions to use the Jintronix system for up 30 minutes up to 3 times per week

Group Type EXPERIMENTAL

Exergame

Intervention Type OTHER

Participants use exergame with the therapist in the rehabilitation center. Several games are available, the therapist adjusts the choice of game and level of difficulty according to the participant's abilities and interests.

Control group

Participants continue their prescribed rehabilitation sessions

Group Type OTHER

usual care

Intervention Type OTHER

participants continued their planned rehabilitation sessions

Interventions

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Exergame

Participants use exergame with the therapist in the rehabilitation center. Several games are available, the therapist adjusts the choice of game and level of difficulty according to the participant's abilities and interests.

Intervention Type OTHER

usual care

participants continued their planned rehabilitation sessions

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* having had an ischemic or hemorrhagic stroke for the first time;
* having residual mild to moderate UE impairment (score 3-6 on the Chedoke-McMaster arm component, as long as exergames can be played);
* being in subacute stage (within 6 months post-stroke);
* receiving usual out-patient rehabilitation services at one of the two selected rehabilitation sites, located in the greater Montreal area in Canada.

Exclusion Criteria

* being medically unstable;
* having severe cognitive or communication deficits;
* having visual impairments limiting use of the exergame;
* having any medical contraindication for shoulder movements;
* having severe balance deficits limiting sitting safely independently;
* having previous upper limb impairment limiting potential recovery;
* having any other impairment that limited use of the exergame.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Université de Montréal

OTHER

Sponsor Role lead

Responsible Party

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Dahlia Kairy

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Université de Montréal

Montreal, Quebec, Canada

Site Status

Countries

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Canada

Other Identifiers

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CRIR-795-0113

Identifier Type: -

Identifier Source: org_study_id