The Jintronix Interactive System for Upper Extremity Rehabilitation Training Post Stroke
Primary Purpose
Stroke
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Exergame
usual care
Sponsored by

About this trial
This is an interventional treatment trial for Stroke focused on measuring virtual reality, exergame, stroke rehabilitation
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.
Sites / Locations
- Université de Montréal
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Intervention arm, usual rehabilitation + Jintronix exergame
Control group
Arm 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
Participants continue their prescribed rehabilitation sessions
Outcomes
Primary Outcome Measures
number of sessions (feasibility)
number of sessions the participant used the system during the study period
duration of sessions
the average duration of sessions (minutes)
time spent by therapist assisting the participant
time during the sessions that the therapist spent assisting the participant (minutes)
time spent on each exergame
the time spent on each exergame (minutes)
adverse event (counts)
occurrence of adverse events such as falls, motion sickness, dizziness and headaches
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
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.
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.
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.
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
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03759145
First Posted
November 27, 2018
Last Updated
November 28, 2018
Sponsor
Université de Montréal
1. Study Identification
Unique Protocol Identification Number
NCT03759145
Brief Title
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
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
March 2014 (Actual)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Université de Montréal
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
virtual reality, exergame, stroke rehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention arm, usual rehabilitation + Jintronix exergame
Arm Type
Experimental
Arm 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
Arm Title
Control group
Arm Type
Other
Arm Description
Participants continue their prescribed rehabilitation sessions
Intervention Type
Other
Intervention Name(s)
Exergame
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
usual care
Intervention Description
participants continued their planned rehabilitation sessions
Primary Outcome Measure Information:
Title
number of sessions (feasibility)
Description
number of sessions the participant used the system during the study period
Time Frame
4 week period
Title
duration of sessions
Description
the average duration of sessions (minutes)
Time Frame
4 week period (ongoing)
Title
time spent by therapist assisting the participant
Description
time during the sessions that the therapist spent assisting the participant (minutes)
Time Frame
4 week period (ongoing)
Title
time spent on each exergame
Description
the time spent on each exergame (minutes)
Time Frame
4 week period (ongoing)
Title
adverse event (counts)
Description
occurrence of adverse events such as falls, motion sickness, dizziness and headaches
Time Frame
4 week period (ongoing)
Title
adverse event (borg exertion scale, self-reported scale 6-20, (Borg Exertion Scale scored from 6-20, no exertion to maximal exertion)
Description
exertion after playing the exergame reported using the Borg Exertion Scale
Time Frame
4 week period (ongoing)
Title
adverse event (pain self reported on visual analog scale 0-10)
Description
pain after playing the exergame reported using visual analog scale 0-10, 0 is no pain, 10 is the worse pain imaginable.
Time Frame
4 week period (ongoing)
Title
Stroke-specific measure of quality of life - Stroke Impact Scale
Description
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.
Time Frame
4 week period (per-post)
Title
upper limb function assessed using the Motor Activity Log
Description
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.
Time Frame
4 week period (per-post)
Title
upper limb function assessed using the Box and Block test
Description
upper limb function is assessed using the box and block test where participants are timed while picking up and placing wooden cubes
Time Frame
4 week period (per-post)
Title
upper limb motor control assessed using the Fugl-Meyer Assessment-upper extremity
Description
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.
Time Frame
4 week period (per-post)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Université de Montréal
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H3N 1X7
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Jintronix Interactive System for Upper Extremity Rehabilitation Training Post Stroke
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