StrokeNCT03759106
Optimizing a Home-based Virtual Reality Exercise Program for Chronic Stroke Patients: A Telerehabilitation Approach
A study testing home written exercise program and telerehabilitation/exergame system in people with Stroke, run by Université de Montréal at 1 site in Canada.
Trial summary
Stroke is a leading cause of death and long-term disability worldwide and its incidence is on the rise. Importantly, loss of arm function occurs in up to 85% of stroke survivors, with a significant long-term impact on activities of daily living, leisure activities and work. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- home written exercise program and telerehabilitation/exergame system
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteCanada
- Study dates
- 27 Jun 2019to Dec 2023
- 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
- Ischemic or hemorrhagic stroke (does not have to be a first time stroke);
- Mild to moderate upper limb impairment (score 2-6 Chedoke-McMaster arm component or ability to perform VR tasks at least at the lowest setting according to clinician);
- No longer receiving rehabilitation services;
- living in an area where high speed Internet access is available.
Who cannot join
- Being medically unstable;
- Severe cognitive or communication deficits;
- Visual impairments;
- Severe balance deficits limiting sitting safely independently;
- Shoulder pain limiting movements for the game;
- Previous upper limb impairment limiting potential recovery.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Université de Montréal
Montreal, Quebec, H3N 1X7
Dorra Allegue, MSc, dorra.allegue@umontreal.ca
Alejandro Hernandez, MSc, alejandro.hernandez@mail.mcgill.ca
About this study
Stroke is a leading cause of death and long-term disability worldwide and its incidence is on the rise. Importantly, loss of arm function occurs in up to 85% of stroke survivors, with a significant long-term impact on activities of daily living, leisure activities and work. The capacity for recovery following a stroke depends on several factors, including the extent of the initial neurological damage, spontaneous recovery and rehabilitation, with possible recovery even years after the stroke. Unfortunately, accessibility of much needed rehabilitation services poststroke often remains limited, both in terms of intensity and duration, as reported in a recent report on post-stroke rehabilitation services in Quebec. Recent evidence suggests that homebased telerehabilitation (TR) is a viable approach for upper limb training post-stroke when rehabilitation services are not available. Similarly, the Canadian Best Practice Recommendations for Stroke Care update for 2013 recommends home-based patient monitoring be used when frequent monitoring is needed and face-to-face visits are not available. Hence, the investigators have developed and propose to examine the use of the VirTele system for people who have suffered a stroke who are no longer receiving rehabilitation services The VirTele system allows upper limb rehabilitation using exergames with ongoing off-line monitoring combined with online monitoring and coaching based on the self-determination theory.
Read the detailed description
More specifically, the primary objective of the RCT is to provide preliminary evidence regarding efficacy of the VirTele program for upper limb motor control recovery in chronic stroke. Secondary objectives are to: i. Determine the effect of the VirTele program on upper limb function, quality of life and motivation; ii. Determine the feasibility of using the VirTele program with users at home (e.g. adherence, safety, technical difficulties, facilitators and barriers); iii. Explore the role that shared decision-making and empowerment play in exercise program adherence and progression, and in behavior modification for upper-limb use.
This study will also provide evidence of feasibility for conducting a larger-scale RCT comparing different technologies and interventions for chronic stroke rehabilitation.
A single-blind (evaluator) two-arm randomized clinical trial (RCT) is proposed for this study with participants who have had a stroke randomly allocated to: (1) 8-week training with the VirTele system.i.e. treatment group or (2) 8-week written home exercise program provided by a clinician (GRASP), i.e. exercise control group.
- Conditions
- Stroke
- Being tested
- home written exercise program, telerehabilitation/exergame system
- Keywords
- Virtual reality, telerehabilitation, 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.
home written exercise programOther
exercises such as picking up objects, placing objects, frequently prescribed at discharge
telerehabilitation/exergame systemOther
Video games using the Kinect camera that are carried out using the impaired arm and monitored by a therapist by videoconferencing
| Study group | Role | What they receive |
|---|---|---|
| No Intervention: Usual care | Other | All study participants in the control group will receive an 8-week written home exercise program (e.g. GRASP) , i.e. the usual care discharge home program. Receives: Other: home written exercise program |
| Experimental: Telerehabilitation system | Experimental | Participants in the experimental group will receive 8 weeks home exercise program using a virtual reality (VR) and telerehabilitation system. The intensity and choice of game for the home program will be determined by the therapist based on the patient's abilities, interests, motivation and fatigue. The patient's performance for the VR home program will be monitored asynchronously and synchronously and the program adapted to ensure it remains at an appropriate level for the patient. Receives: Other: telerehabilitation/exergame system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Upper limb motor control at 8 weeks as measured using the Fugl-Meyer Assessment-UE (FMA-UE)
Upper limb motor control is assessed using a valid and reliable outcome, scores between 0-66, higher scores indicating better motor control. measure consisting of tasks to be performed by the participant
Measured: baseline and eight weeks after intervention, as well as 1 and 2 month follow up
Secondary outcomes (10)
Change from Baseline in Upper limb function at 8 weeks Impact on upper extremity use in daily activities will be using the Motor Activity Log, a self-reported measure of upper limb use
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: baseline and eight weeks after intervention, as well as 1 and 2 month follow up
Change from Baseline in Upper limb function at 8 weeks using the Wolf Motor Function Test
The Wolf Motor Function test consists of tasks that are performed by the participant with the impaired upper extremity, the tasks are rated for the quality of movement and the time taken. Items are scored on a 6 point scale, from does not attempt to movement is normal. Times tests are truncated at 120 seconds. A mean score out of a maximum of 5 is calculated.
Measured: baseline and eight weeks after intervention, as well as 1 and 2 month follow up
number of sessions (feasibility)
number of sessions played (count)
Measured: 8 weeks (ongoing)
duration of sessions (Feasibility)
average duration of sessions played (minutes)
Measured: 8 weeks (ongoing)
Amount of time spent on the actual exe games (moving the arm)
amount of actual time spent using the impaired arm during the sessions (minutes)
Measured: 8 weeks (ongoing)
Frequency of on-line consultations with therapist
Number of times real-time sessions are held between the therapist and the participant (online)
Measured: 8 weeks (ongoing)
duration (minutes) of on-line consultations with therapist
average time spent by the therapist assisting for real-time sessions
Measured: 8 weeks (ongoing)
adverse event (counts)
occurrence of adverse events (falls, motion sickness, dizziness, headaches) will be documented using a computerized patient log after each session.
Measured: 8 weeks (ongoing)
falls (count)
occurrence of falls documented by the participant
Measured: 8 weeks (ongoing)
adverse event - exertion (Borg Exertion Scale scored from 6-20, no exertion to maximal exertion)
self perceived exertion rated by the participant after the session (i.e. playing the exergame) on a scale 6-20, (no exertion to maximal exertion)
Measured: 8 weeks (ongoing)
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 start27 Jun 2019
- Primary completionMay 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université de Montréal
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Dahlia Kairy, Université de Montréal
- Investigators
- Dahlia Kairy, PhD, Principal investigator, Université de Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03759106
- Sponsor's protocol ID
- CRIR-1319-0218
- Status last verified
- Nov 2022
- First submitted
- 27 Nov 2018
- Last updated
- 14 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Allegue DR, Kairy D, Higgins J, Archambault P, Michaud F, Miller W, Sweet SN, Tousignant M. Optimization of Upper Extremity Rehabilitation by Combining Telerehabilitation With an Exergame in People With Chronic Stroke: Protocol for a Mixed Methods Study. JMIR Res Protoc. 2020 May 21;9(5):e14629. doi: 10.2196/14629.
PubMed 32097119
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing a Home-based Virtual Reality Exercise Program for Chronic Stroke Patients: A Telerehabilitation Approach
- ClinicalTrials.gov ID
- NCT03759106
- Acronym / sponsor ID
- CRIR-1319-0218
- Conditions
- Stroke
- Keywords
- Virtual reality, telerehabilitation, Stroke rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Université de MontréalUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 27 Jun 2019 (actual)
- Primary completion
- May 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- 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 long-term disability worldwide and its incidence is on the rise. Importantly, loss of arm function occurs in up to 85% of stroke survivors, with a significant long-term impact on activities of daily living, leisure activities and work. The capacity for recovery following a stroke depends on several factors, including the extent of the initial neurological damage, spontaneous recovery and rehabilitation, with possible recovery even years after the stroke. Unfortunately, accessibility of much needed rehabilitation services poststroke often remains limited, both in terms of intensity and duration, as reported in a recent report on post-stroke rehabilitation services in Quebec. Recent evidence suggests that homebased telerehabilitation (TR) is a viable approach for upper limb training post-stroke when rehabilitation services are not available. Similarly, the Canadian Best Practice Recommendations for Stroke Care update for 2013 recommends home-based patient monitoring be used when frequent monitoring is needed and face-to-face visits are not available. Hence, the investigators have developed and propose to examine the use of the VirTele system for people who have suffered a stroke who are no longer receiving rehabilitation services The VirTele system allows upper limb rehabilitation using exergames with ongoing off-line monitoring combined with online monitoring and coaching based on the self-determination theory.
Detailed description
More specifically, the primary objective of the RCT is to provide preliminary evidence regarding efficacy of the VirTele program for upper limb motor control recovery in chronic stroke. Secondary objectives are to: i. Determine the effect of the VirTele program on upper limb function, quality of life and motivation; ii. Determine the feasibility of using the VirTele program with users at home (e.g. adherence, safety, technical difficulties, facilitators and barriers); iii. Explore the role that shared decision-making and empowerment play in exercise program adherence and progression, and in behavior modification for upper-limb use.
This study will also provide evidence of feasibility for conducting a larger-scale RCT comparing different technologies and interventions for chronic stroke rehabilitation.
A single-blind (evaluator) two-arm randomized clinical trial (RCT) is proposed for this study with participants who have had a stroke randomly allocated to: (1) 8-week training with the VirTele system.i.e. treatment group or (2) 8-week written home exercise program provided by a clinician (GRASP), i.e. exercise 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 |
|---|---|---|
| No Intervention: Usual care | Other | Other: home written exercise programAll study participants in the control group will receive an 8-week written home exercise program (e.g. GRASP) , i.e. the usual care discharge home program. |
| Experimental: Telerehabilitation system | Experimental | Other: telerehabilitation/exergame systemParticipants in the experimental group will receive 8 weeks home exercise program using a virtual reality (VR) and telerehabilitation system. The intensity and choice of game for the home program will be determined by the therapist based on the patient's abilities, interests, motivation and fatigue. The patient's performance for the VR home program will be monitored asynchronously and synchronously and the program adapted to ensure it remains at an appropriate level for the patient. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Ischemic or hemorrhagic stroke (does not have to be a first time stroke);
- Mild to moderate upper limb impairment (score 2-6 Chedoke-McMaster arm component or ability to perform VR tasks at least at the lowest setting according to clinician);
- No longer receiving rehabilitation services;
- living in an area where high speed Internet access is available.
Key exclusion criteria (6 listed)
- Being medically unstable;
- Severe cognitive or communication deficits;
- Visual impairments;
- Severe balance deficits limiting sitting safely independently;
- Shoulder pain limiting movements for the game;
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 |
|---|---|---|
| home written exercise programexercises such as picking up objects, placing objects, frequently prescribed at discharge | Other | No Intervention: Usual care |
| telerehabilitation/exergame systemVideo games using the Kinect camera that are carried out using the impaired arm and monitored by a therapist by videoconferencing | Other | Experimental: Telerehabilitation system |
Primary outcome
Change from Baseline in Upper limb motor control at 8 weeks as measured using the Fugl-Meyer Assessment-UE (FMA-UE)
Time frame: baseline and eight weeks after intervention, as well as 1 and 2 month follow up
Upper limb motor control is assessed using a valid and reliable outcome, scores between 0-66, higher scores indicating better motor control. measure consisting of tasks to be performed by the participant
10 secondary outcomes
Change from Baseline in Upper limb function at 8 weeks Impact on upper extremity use in daily activities will be using the Motor Activity Log, a self-reported measure of upper limb use
Time frame: baseline and eight weeks after intervention, as well as 1 and 2 month follow up
Change from Baseline in Upper limb function at 8 weeks using the Wolf Motor Function Test
Time frame: baseline and eight weeks after intervention, as well as 1 and 2 month follow up
number of sessions (feasibility)
Time frame: 8 weeks (ongoing)
duration of sessions (Feasibility)
Time frame: 8 weeks (ongoing)
Amount of time spent on the actual exe games (moving the arm)
Time frame: 8 weeks (ongoing)
Frequency of on-line consultations with therapist
Time frame: 8 weeks (ongoing)
duration (minutes) of on-line consultations with therapist
Time frame: 8 weeks (ongoing)
adverse event (counts)
Time frame: 8 weeks (ongoing)
falls (count)
Time frame: 8 weeks (ongoing)
adverse event - exertion (Borg Exertion Scale scored from 6-20, no exertion to maximal exertion)
Time frame: 8 weeks (ongoing)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2022.
- Derived from this study: PubMed 32097119Allegue DR, Kairy D, Higgins J, Archambault P, Michaud F, Miller W, Sweet SN, Tousignant M. Optimization of Upper Extremity Rehabilitation by Combining Telerehabilitation With an Exergame in People With Chronic Stroke: Protocol for a Mixed Methods Study. JMIR Res Protoc. 2020 May 21;9(5):e14629. doi: 10.2196/14629.
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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.
Dahlia Kairy, PhD principal investigator
Université de Montréal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing home written exercise program and telerehabilitation/exergame system 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 6 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: status not confirmed, as of the sponsor's last update on 14 Nov 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alejandro Hernandez, MSc (514-340-2085, alejandro.hernandez@mail.mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Upper limb motor control at 8 weeks as measured using the Fugl-Meyer Assessment-UE (FMA-UE) (time frame: baseline and eight weeks after intervention, as well as 1 and 2 month follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03759106, which also lists 1 linked publication.
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 14 Nov 2022.