Clinical trial NCT03759145: The Jintronix Interactive System for Upper Extremity Rehabilitation Training Post Stroke
Official title: The Jintronix Interactive System for Upper Extremity Rehabilitation Training Post Stroke: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: virtual reality
exergame
stroke rehabilitation
Lead sponsor: Université de Montréal
Sponsor class: OTHER
First posted: 2018-11-29
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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).

Eligibility criteria: 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.

Primary outcomes:
measure: number of sessions (feasibility)
timeFrame: 4 week period
measure: duration of sessions
timeFrame: 4 week period (ongoing)
measure: time spent by therapist assisting the participant
timeFrame: 4 week period (ongoing)
measure: time spent on each exergame
timeFrame: 4 week period (ongoing)
measure: adverse event (counts)
timeFrame: 4 week period (ongoing)
measure: adverse event (borg exertion scale, self-reported scale 6-20, (Borg Exertion Scale scored from 6-20, no exertion to maximal exertion)
timeFrame: 4 week period (ongoing)
measure: adverse event (pain self reported on visual analog scale 0-10)
timeFrame: 4 week period (ongoing)
measure: Stroke-specific measure of quality of life - Stroke Impact Scale
timeFrame: 4 week period (per-post)
measure: upper limb function assessed using the Motor Activity Log
timeFrame: 4 week period (per-post)
measure: upper limb function assessed using the Box and Block test
timeFrame: 4 week period (per-post)
measure: upper limb motor control assessed using the Fugl-Meyer Assessment-upper extremity
timeFrame: 4 week period (per-post)
Secondary outcomes:
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Université de Montréal
state: Quebec
Study officials:
References: