The Jintronix Interactive System for Upper Extremity Rehabilitation Training Post Stroke

Université de Montréal

Status: Completed

Conditions: Stroke

Treatments: Other: usual care; Other: Exergame

Study type: Interventional

Funder types: Other

Identifiers

NCT03759145

CRIR-795-0113

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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18 participants in 2 patient groups

Intervention arm, usual rehabilitation + Jintronix exergame

Experimental group

Description:

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

Treatment:

Other: Exergame

Control group

Other group

Description:

Participants continue their prescribed rehabilitation sessions

Treatment:

Other: usual care