The Jintronix Interactive System for Upper Extremity Rehabilitation Training Post Stroke

• ClinicalTrials.gov Identifier: NCT03759145
• Recruitment Status: Completed
• First Posted: November 29, 2018
• Last Update Posted: November 30, 2018
• Sponsor: Université de Montréal
• Information provided by (Responsible Party): Dahlia Kairy, Université de Montréal

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Stroke	Other: Exergame; Other: usual care	Not Applicable

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).

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 18 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: The Jintronix Interactive System for Upper Extremity Rehabilitation Training Post Stroke: A Pilot Study
• Actual Study Start Date: March 2014
• Actual Primary Completion Date: January 2016
• Actual Study Completion Date: January 2016

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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	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.
Control group; Participants continue their prescribed rehabilitation sessions	Other: usual care; participants continued their planned rehabilitation sessions

Outcome Measures

Primary Outcome Measures :

1. number of sessions (feasibility) [ Time Frame: 4 week period ]
   number of sessions the participant used the system during the study period
2. duration of sessions [ Time Frame: 4 week period (ongoing) ]
   the average duration of sessions (minutes)
3. time spent by therapist assisting the participant [ Time Frame: 4 week period (ongoing) ]
   time during the sessions that the therapist spent assisting the participant (minutes)
4. time spent on each exergame [ Time Frame: 4 week period (ongoing) ]
   the time spent on each exergame (minutes)
5. adverse event (counts) [ Time Frame: 4 week period (ongoing) ]
   occurrence of adverse events such as falls, motion sickness, dizziness and headaches
6. adverse event (borg exertion scale, self-reported scale 6-20, (Borg Exertion Scale scored from 6-20, no exertion to maximal exertion) [ Time Frame: 4 week period (ongoing) ]
   exertion after playing the exergame reported using the Borg Exertion Scale
7. adverse event (pain self reported on visual analog scale 0-10) [ Time Frame: 4 week period (ongoing) ]
   pain after playing the exergame reported using visual analog scale 0-10, 0 is no pain, 10 is the worse pain imaginable.
8. Stroke-specific measure of quality of life - Stroke Impact Scale [ Time Frame: 4 week period (per-post) ]
   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.
9. upper limb function assessed using the Motor Activity Log [ Time Frame: 4 week period (per-post) ]
   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.
10. upper limb function assessed using the Box and Block test [ Time Frame: 4 week period (per-post) ]
    upper limb function is assessed using the box and block test where participants are timed while picking up and placing wooden cubes
11. upper limb motor control assessed using the Fugl-Meyer Assessment-upper extremity [ Time Frame: 4 week period (per-post) ]
    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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

Canada, Quebec

Université de Montréal

Montréal, Quebec, Canada, H3N 1X7

Sponsors and Collaborators

Université de Montréal

More Information

• Responsible Party: Dahlia Kairy, Associate professor, Université de Montréal
• ClinicalTrials.gov Identifier: NCT03759145
• Other Study ID Numbers: CRIR-795-0113
• First Posted: November 29, 2018
• Last Update Posted: November 30, 2018
• Last Verified: November 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dahlia Kairy, Université de Montréal:

virtual reality; exergame; stroke rehabilitation

Additional relevant MeSH terms:

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases