StrokeNCT03759145
The Jintronix Interactive System for Upper Extremity Rehabilitation Training Post Stroke
A study testing Exergame in people with Stroke, run by Université de Montréal at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Exergame
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2014to Jan 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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).
- Conditions
- Stroke
- Being tested
- Exergame, usual care
- Keywords
- virtual reality, exergame, stroke rehabilitation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExergameOther
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 careOther
participants continued their planned rehabilitation sessions
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm, usual rehabilitation + Jintronix exergame | Experimental | 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 Receives: Other: Exergame |
| Control group | Other | Participants continue their prescribed rehabilitation sessions Receives: Other: usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of sessions (feasibility)
number of sessions the participant used the system during the study period
Measured: 4 week period
duration of sessions
the average duration of sessions (minutes)
Measured: 4 week period (ongoing)
time spent by therapist assisting the participant
time during the sessions that the therapist spent assisting the participant (minutes)
Measured: 4 week period (ongoing)
time spent on each exergame
the time spent on each exergame (minutes)
Measured: 4 week period (ongoing)
adverse event (counts)
occurrence of adverse events such as falls, motion sickness, dizziness and headaches
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 4 week period (per-post)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2018
- Study startMar 2014
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Montréal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dahlia Kairy, Université de Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03759145
- Sponsor's protocol ID
- CRIR-795-0113
- Status last verified
- Nov 2018
- First submitted
- 27 Nov 2018
- Last updated
- 30 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Jintronix Interactive System for Upper Extremity Rehabilitation Training Post Stroke: A Pilot Study
- ClinicalTrials.gov ID
- NCT03759145
- Acronym / sponsor ID
- CRIR-795-0113
- Conditions
- Stroke
- Keywords
- virtual reality, exergame, stroke rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Université de MontréalUniversity, hospital or other
- Study start
- Mar 2014 (actual)
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 29 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention arm, usual rehabilitation + Jintronix exergame | Experimental | Other: ExergameOn 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 |
| Control group | Other | Other: usual careParticipants continue their prescribed rehabilitation sessions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExergameParticipants 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 | Intervention arm, usual rehabilitation + Jintronix exergame |
| usual careparticipants continued their planned rehabilitation sessions | Other | Control group |
Primary outcome
number of sessions (feasibility)
Time frame: 4 week period
number of sessions the participant used the system during the study period
duration of sessions
Time frame: 4 week period (ongoing)
the average duration of sessions (minutes)
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)
time spent on each exergame
Time frame: 4 week period (ongoing)
the time spent on each exergame (minutes)
adverse event (counts)
Time frame: 4 week period (ongoing)
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)
Time frame: 4 week period (ongoing)
exertion after playing the exergame reported using the Borg Exertion Scale
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.
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.
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.
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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exergame in people with Stroke, run by Université de Montréal at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of sessions (feasibility) (time frame: 4 week period). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2018.