The Jintronix Interactive System for Upper Extremity Rehabilitation Training Post Stroke

Stroke Clinical Trial

Official title:

The Jintronix Interactive System for Upper Extremity Rehabilitation Training Post Stroke: A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03759145
• Other study ID #: CRIR-795-0113
• Status: Completed
• Phase: N/A
• Start date: March 2014
• Est. completion date: January 2016

Study information

• Verified date: November 2018
• Source: Université de Montréal
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• 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.
• usual care
participants continued their planned rehabilitation sessions

Locations

Country	Name	City	State
Canada	Université de Montréal	Montréal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Université de Montréal

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of sessions (feasibility)	number of sessions the participant used the system during the study period	4 week period
Primary	duration of sessions	the average duration of sessions (minutes)	4 week period (ongoing)
Primary	time spent by therapist assisting the participant	time during the sessions that the therapist spent assisting the participant (minutes)	4 week period (ongoing)
Primary	time spent on each exergame	the time spent on each exergame (minutes)	4 week period (ongoing)
Primary	adverse event (counts)	occurrence of adverse events such as falls, motion sickness, dizziness and headaches	4 week period (ongoing)
Primary	adverse event (borg exertion scale, self-reported scale 6-20, (Borg Exertion Scale scored from 6-20, no exertion to maximal exertion)	exertion after playing the exergame reported using the Borg Exertion Scale	4 week period (ongoing)
Primary	adverse event (pain self reported on visual analog scale 0-10)	pain after playing the exergame reported using visual analog scale 0-10, 0 is no pain, 10 is the worse pain imaginable.	4 week period (ongoing)
Primary	Stroke-specific measure of quality of life - Stroke Impact Scale	Stroke Impact Scale is a questionnaire of the impact that the stroke is having on function, mood, emotional status, total score 0-100, with with higher scores indicating better self-reported health.	4 week period (per-post)
Primary	upper limb function assessed using the Motor Activity Log	The Motor Activity Log is a questionnaire that the participant completes reporting how much the impaired upper limb is used for various daily tasks, each task is scored from 0-5 (ordinal scale, 0=do not use arm - 6=use as much as before), total score is mean of the scores.	4 week period (per-post)
Primary	upper limb function assessed using the Box and Block test	upper limb function is assessed using the box and block test where participants are timed while picking up and placing wooden cubes	4 week period (per-post)
Primary	upper limb motor control assessed using the Fugl-Meyer Assessment-upper extremity	Upper limb motor control is assessed using a valid and reliable outcome, measure consisting of tasks to be performed by the participant, scores between 0-66, higher scores indicating better motor control.	4 week period (per-post)