The Jintronix Interactive System for Upper Extremity Rehabilitation Training Post Stroke

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

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.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Other: Exergame; Other: usual care

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 Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada, H3N 1X7
      • Université de Montréal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.
Other: Control group; Participants continue their prescribed rehabilitation sessions	Other: usual care; participants continued their planned rehabilitation sessions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of sessions (feasibility)	number of sessions the participant used the system during the study period	4 week period
duration of sessions	the average duration of sessions (minutes)	4 week period (ongoing)
time spent by therapist assisting the participant	time during the sessions that the therapist spent assisting the participant (minutes)	4 week period (ongoing)
time spent on each exergame	the time spent on each exergame (minutes)	4 week period (ongoing)
adverse event (counts)	occurrence of adverse events such as falls, motion sickness, dizziness and headaches	4 week period (ongoing)
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)
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)
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)
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)
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)
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)

Collaborators and Investigators

• Sponsor: Université de Montréal

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2014
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): January 1, 2016

Study Registration Dates

• First Submitted: November 27, 2018
• First Submitted That Met QC Criteria: November 27, 2018
• First Posted (Actual): November 29, 2018

Study Record Updates

• Last Update Posted (Actual): November 30, 2018
• Last Update Submitted That Met QC Criteria: November 28, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: virtual reality; stroke rehabilitation; exergame
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: CRIR-795-0113

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No