StrokeNCT04945356
Telerehabilitation During Pandemic Containment Measures of COVID19
A study testing upper limb training in people with Stroke, run by Université de Sherbrooke at 3 sites in Canada.
Trial summary
BACKGROUND: Although rehabilitation is effective in restoring function, many elderly individuals, especially those who have survived a stroke, are no longer receiving adequate rehabilitation services during the COVID19 pandemic due to containment measures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- upper limb training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 3 sitesCanada
- Study dates
- 28 Oct 2020to 31 Dec 2021
- 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
- be over 18 years of age;
- present a single unilateral stroke for more than 6 months;
- have a minimal motor return to the upper limb assessed visually via the visuo-conference platform;
- no longer receiving any in- or outpatient rehabilitation services.
Who cannot join
- severe spasticity that prevents movement of the affected limb (score > 3 on the modified Ashworth scale);
- an orthopedic problem with the affected upper limb or lower limb;
- any neurological problem other than that arising from a stroke;
- cognitive impairment (a score ≤ 2/5 on the Mini-Cog Test);
- fall that has required physician evaluation within the past six months;
- other neurologic, neuromuscular, or orthopedic disease or comorbidities that would prevent exercise participation or increase participant risk;
- vision or hearing, communication, literacy or perceptual impairment that would interfere with app use as assessed by the study physical therapist during the screening process through a direct demonstration of the app and try out of the app
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Université du Québec à Chicoutimi
Chicoutimi, Quebec, G7H 2B1
McGill University
Montreal, Quebec
Centre de recherche sur le vieillissement
Sherbrooke, Quebec, J1H4C4
About this study
Official title: The Use of Telerehabilitation to Improve Function and Quality of Life for People in the Chronic Phase After Stroke During Pandemic Containment Measures of COVID19 : a Feasibility Pilot Study
BACKGROUND:
Although rehabilitation is effective in restoring function, many elderly individuals, especially those who have survived a stroke, are no longer receiving adequate rehabilitation services during the COVID19 pandemic due to containment measures. To overcome this problem, telerehabilitation is a promising avenue to deliver customized and personalized at-home therapy sessions while adhering to physical distancing guidelines.
Read more
OBJECTIVES:
The primary objective of this study is to evaluate the feasibility of using customized and personalized at-home therapy sessions using the Physiotec application for individuals with a stroke. A second objective is to measure the potential efficacy of the telerehabilitation intervention at improving function and quality of life based on standardized clinical measures and measures of improvement implemented in the Physiotec application.
METHODS:
We propose a non-randomized, single-group trial. Twenty-five individuals will be recruited on a voluntary basis. To be included, participants must 1) be ≥18 years old; 2) have a single unilateral stroke (≥ 6 months); 3) have minimal return of function in the affected upper limb; and 4) no longer be receiving rehabilitation treatments. Participants will receive a tablet containing the Physiotec application training program and TERA+, a telerehabilitation platform. The training program of the affected upper limb will last 6 weeks (90 minutes/week) and will be updated 3 times (weeks 1-3-5) by the therapist, using the TERA+ platform, based on the participant's functional capacity and progress, as measured by the app. Feasibility will be assessed by means of retention rate, adverse events, adherence to the telerehabilitation intervention, satisfaction with its use and with the exercise program. Efficacy will be assessed by several questionnaires on life habits, motor recovery and quality of life.
RELEVANCE:
This study will inform as to the optimal delivery of adapted rehabilitation services for stroke survivors that are currently not receiving optimal rehabilitation services because of the ongoing COVID19 pandemic. The results will serve to support in-home rehabilitation exercises aimed at promoting recovery, independent living and improving quality of life for stroke survivors.
- Conditions
- Stroke
- Being tested
- upper limb training
- Keywords
- stroke, telerehabilitation, COVID19, function, upper limb, quality of life
- Medical subject headings
- Stroke, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
upper limb trainingOther
The 6-week exercise program will consist of evidence-based exercises covering the breadth and depth of rehabilitation interventions. The therapist will choose the appropriate exercises for each participant's level of function from more than 15,000 exercises implemented within the Physiotec app and developed by rehabilitation experts. Personalized upper limb exercises will be based on the therapist initial assessment of participants, using the TERA+ telerehabilitation platform, and their goals. After each training session, participants will have to rate their perceived level of effort on a Borg scale (/10). The Borg scores will be monitored by the therapist as a precautionary measure to ensure safety and appropriateness of intensity of exercises. Participants will be instructed to train at a target score of around 7/10 (somewhat hard) on the Borg scale.
| Study group | Role | What they receive |
|---|---|---|
| upper limb virtual training | Experimental | 6-week virtual training of the affected upper limb using the Physiotec application Receives: Other: upper limb training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention rate to the telerehabilitation intervention
the number of participants enrolled at the end of the study divided by the number of participants recruited at the beginning of the study
Measured: in the week after the last session of telerehabilitation training
Adherence to the telerehabilitation training program
the number of telerehabilitation training sessions that participants took part in during the 6-week training program
Measured: in the week after the last session of telerehabilitation training
Adverse events related to the intensity of training assessed with the Borg scale embedded within the Physiotec application
Adverse events related to the intensity of training will be tracked after each training session via the BORG scale (intensity of training should not be done at a score higher than 7/10)
Measured: after each training session throughout the duration of the telerehabilitation training program
Adverse events related to pain levels assessed with the visual analog scale embedded within the Physiotec application
Adverse events related to pain will be tracked after each training session with a 0-10 visual analog scale for pain (training will be adjusted if pain score is greater than 7/10).
Measured: after each training session throughout the duration of the telerehabilitation training program
Participants' satisfaction with telerehabilitation assessed with the Telerehabilitation Satisfaction questionnaire
Telerehabilitation Satisfaction questionnaire: this questionnaire contains 15 questions where the participants rate their satisfaction about the use of telerehabilitation on a Likert scale (from strongly agree to strongly disagree or undecided).
Measured: in the week after the last session of telerehabilitation training
Participants' satisfaction with the application assessed with the User Satisfaction questionnaire
User Satisfaction questionnaire: this questionnaire contains 6 questions about the participants satisfaction about the application (from 1 = not at all to 5 = extremely)
Measured: in the week after the last session of telerehabilitation training
Participants' satisfaction with the exercise program assessed with the Health Care Satisfaction questionnaire
Health Care Satisfaction questionnaire: this questionnaire comprises 26 questions about the participants feeling (from 1= not at all to 4= extremely) and the importance they give to different situations (from 1= not important to 4 = extremely important) related to the training program
Measured: in the week after the last session of telerehabilitation training
Secondary outcomes (8)
Change in quality of life assessed with the 12-item Short Form Survey
SF-12: this 12-question health survey assesses both physical and mental components of the respondent's current health status compared to their health status one month ago. It covers 8 domains such as limitations in physical activities because of health problems and bodily pain. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning.
Measured: baseline and in the week after the last session of telerehabilitation training
Change in life habits assessed with the LIFE-H 3.0 questionnaire
LIFE-H 3.0: this test includes 240 items and assesses the level of participation in daily activities and social roles. It also considers the degree of difficulty in carrying out tasks as well as the type of assistance required by the person. Each question is scored on a 0-9 scale where a score of 0 implies a total disruption of participation.
Measured: baseline and in the week after the last session of telerehabilitation training
Change in the quantity and quality of affected upper limb use assessed with the Motor Activity Log
Motor Activity Log-14: this questionnaire assesses, on a 6-point ordinal scale, the use and quality of use of the affected upper limb in 14 everyday activities. A high score means that the participant perceives a greater use of his arm and a better quality of movement.
Measured: baseline and in the week after the last session of telerehabilitation training
Change in reintegration to social activities assessed with the Reintegration to Normal Living Index
Reintegration to Normal Living Index: this questionnaire covers the following domains: indoor, community, distance mobility, self-care, daily activity, recreational and social activities, family role(s), personal relationships, presentation of self to others and general coping skills. Using 11 questions, it quantitatively assesses, on a 0-10 cm visual analogue scale, the degree to which individuals achieve reintegration into normal living. Each score is summed to provide a total score out of 110 points (adjusted back to 100) where a higher score indicates a better perception of reintegration
Measured: baseline and in the week after the last session of telerehabilitation training
Change in motor recovery of affected upper limb assessed with the Stroke Rehabilitation Assessment of Movement
Stroke Rehabilitation Assessment of Movement: it is a performance-based measure that evaluates, on a 3-point ordinal scale, motor recovery at the affected upper limb. The total score for the upper limb section is 20 points with a higher score indicating a better motor recovery.
Measured: baseline and in the week after the last session of telerehabilitation training
Change in range of motion at the affected upper limb assessed visually
Range of motion of the upper extremity will be visually estimated by a research assistant, using the TERA+ platform, for the shoulder (flexion), elbow (flexion \& extension), forearm pronation/supination, wrist (extension \& flexion) and finger (flexion \& extension).
Measured: baseline and in the week after the last session of telerehabilitation training
Participants' perceived improvement of the affected upper limb following training assessed with the Global Rating of Change Score questionnaire
Global Rating of Change Score: this questionnaire will assess the participant's perceived improvement in the function of his trained upper limb on a 7-point ordinal scale from 3 (very much improved) to -3 (very much worse)
Measured: in the week after the last session of telerehabilitation training
Fear of COVID assessed with the Fear of COVID-19 scale
Fear of COVID-19 scale: this 7-item questionnaire will assess the perception of the participants about the COVID19 pandemic using a five-item Likert- type scale (from "strongly disagree" to "strongly agree"). The minimum score possible for each question is 1, and the maximum is 5. A total score is calculated by adding up each item score. The higher the score, the greater the fear of coronavirus-19 is.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2021
- Study start28 Oct 2020
- Primary completion31 Oct 2021
- Study completion31 Dec 2021
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.
- More trials run by Université de SherbrookeThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Collaborators
- McGill University, Université du Québec à Chicoutimi, Université de Montréal
- Responsible party
- Principal investigator, Marie-Hélène Milot, Université de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04945356
- Sponsor's protocol ID
- MP-31-2021-3817
- Status last verified
- Apr 2022
- First submitted
- 24 Jun 2021
- Last updated
- 27 Apr 2022
- 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 27 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Telerehabilitation to Improve Function and Quality of Life for People in the Chronic Phase After Stroke During Pandemic Containment Measures of COVID19 : a Feasibility Pilot Study
- ClinicalTrials.gov ID
- NCT04945356
- Acronym / sponsor ID
- MP-31-2021-3817
- Conditions
- Stroke
- Keywords
- stroke, telerehabilitation, COVID19, function, upper limb, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Collaborators
- McGill University, Université du Québec à Chicoutimi, Université de Montréal
- Study start
- 28 Oct 2020 (actual)
- Primary completion
- 31 Oct 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 30 Jun 2021 (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.
BACKGROUND:
Although rehabilitation is effective in restoring function, many elderly individuals, especially those who have survived a stroke, are no longer receiving adequate rehabilitation services during the COVID19 pandemic due to containment measures. To overcome this problem, telerehabilitation is a promising avenue to deliver customized and personalized at-home therapy sessions while adhering to physical distancing guidelines.
OBJECTIVES:
The primary objective of this study is to evaluate the feasibility of using customized and personalized at-home therapy sessions using the Physiotec application for individuals with a stroke. A second objective is to measure the potential efficacy of the telerehabilitation intervention at improving function and quality of life based on standardized clinical measures and measures of improvement implemented in the Physiotec application.
METHODS:
We propose a non-randomized, single-group trial. Twenty-five individuals will be recruited on a voluntary basis. To be included, participants must 1) be ≥18 years old; 2) have a single unilateral stroke (≥ 6 months); 3) have minimal return of function in the affected upper limb; and 4) no longer be receiving rehabilitation treatments. Participants will receive a tablet containing the Physiotec application training program and TERA+, a telerehabilitation platform. The training program of the affected upper limb will last 6 weeks (90 minutes/week) and will be updated 3 times (weeks 1-3-5) by the therapist, using the TERA+ platform, based on the participant's functional capacity and progress, as measured by the app. Feasibility will be assessed by means of retention rate, adverse events, adherence to the telerehabilitation intervention, satisfaction with its use and with the exercise program. Efficacy will be assessed by several questionnaires on life habits, motor recovery and quality of life.
RELEVANCE:
This study will inform as to the optimal delivery of adapted rehabilitation services for stroke survivors that are currently not receiving optimal rehabilitation services because of the ongoing COVID19 pandemic. The results will serve to support in-home rehabilitation exercises aimed at promoting recovery, independent living and improving quality of life for stroke survivors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| upper limb virtual training | Experimental | Other: upper limb training6-week virtual training of the affected upper limb using the Physiotec application |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- be over 18 years of age;
- present a single unilateral stroke for more than 6 months;
- have a minimal motor return to the upper limb assessed visually via the visuo-conference platform;
- no longer receiving any in- or outpatient rehabilitation services.
Key exclusion criteria (7 listed)
- severe spasticity that prevents movement of the affected limb (score > 3 on the modified Ashworth scale);
- an orthopedic problem with the affected upper limb or lower limb;
- any neurological problem other than that arising from a stroke;
- cognitive impairment (a score ≤ 2/5 on the Mini-Cog Test);
- fall that has required physician evaluation within the past six months;
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 |
|---|---|---|
| upper limb trainingThe 6-week exercise program will consist of evidence-based exercises covering the breadth and depth of rehabilitation interventions. The therapist will choose the appropriate exercises for each participant's level of function from more than 15,000 exercises implemented within the Physiotec app and developed by rehabilitation experts. Personalized upper limb exercises will be based on the therapist initial assessment of participants, using the TERA+ telerehabilitation platform, and their goals. After each training session, participants will have to rate their perceived level of effort on a Borg scale (/10). The Borg scores will be monitored by the therapist as a precautionary measure to ensure safety and appropriateness of intensity of exercises. Participants will be instructed to train at a target score of around 7/10 (somewhat hard) on the Borg scale. | Other | upper limb virtual training |
Primary outcome
Retention rate to the telerehabilitation intervention
Time frame: in the week after the last session of telerehabilitation training
the number of participants enrolled at the end of the study divided by the number of participants recruited at the beginning of the study
Adherence to the telerehabilitation training program
Time frame: in the week after the last session of telerehabilitation training
the number of telerehabilitation training sessions that participants took part in during the 6-week training program
Adverse events related to the intensity of training assessed with the Borg scale embedded within the Physiotec application
Time frame: after each training session throughout the duration of the telerehabilitation training program
Adverse events related to the intensity of training will be tracked after each training session via the BORG scale (intensity of training should not be done at a score higher than 7/10)
Adverse events related to pain levels assessed with the visual analog scale embedded within the Physiotec application
Time frame: after each training session throughout the duration of the telerehabilitation training program
Adverse events related to pain will be tracked after each training session with a 0-10 visual analog scale for pain (training will be adjusted if pain score is greater than 7/10).
Participants' satisfaction with telerehabilitation assessed with the Telerehabilitation Satisfaction questionnaire
Time frame: in the week after the last session of telerehabilitation training
Telerehabilitation Satisfaction questionnaire: this questionnaire contains 15 questions where the participants rate their satisfaction about the use of telerehabilitation on a Likert scale (from strongly agree to strongly disagree or undecided).
Participants' satisfaction with the application assessed with the User Satisfaction questionnaire
Time frame: in the week after the last session of telerehabilitation training
User Satisfaction questionnaire: this questionnaire contains 6 questions about the participants satisfaction about the application (from 1 = not at all to 5 = extremely)
Participants' satisfaction with the exercise program assessed with the Health Care Satisfaction questionnaire
Time frame: in the week after the last session of telerehabilitation training
Health Care Satisfaction questionnaire: this questionnaire comprises 26 questions about the participants feeling (from 1= not at all to 4= extremely) and the importance they give to different situations (from 1= not important to 4 = extremely important) related to the training program
8 secondary outcomes
Change in quality of life assessed with the 12-item Short Form Survey
Time frame: baseline and in the week after the last session of telerehabilitation training
Change in life habits assessed with the LIFE-H 3.0 questionnaire
Time frame: baseline and in the week after the last session of telerehabilitation training
Change in the quantity and quality of affected upper limb use assessed with the Motor Activity Log
Time frame: baseline and in the week after the last session of telerehabilitation training
Change in reintegration to social activities assessed with the Reintegration to Normal Living Index
Time frame: baseline and in the week after the last session of telerehabilitation training
Change in motor recovery of affected upper limb assessed with the Stroke Rehabilitation Assessment of Movement
Time frame: baseline and in the week after the last session of telerehabilitation training
Change in range of motion at the affected upper limb assessed visually
Time frame: baseline and in the week after the last session of telerehabilitation training
Participants' perceived improvement of the affected upper limb following training assessed with the Global Rating of Change Score questionnaire
Time frame: in the week after the last session of telerehabilitation training
Fear of COVID assessed with the Fear of COVID-19 scale
Time frame: baseline
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 27 Apr 2022.
- 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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing upper limb training in people with Stroke, run by Université de Sherbrooke at 3 sites 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 27 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Retention rate to the telerehabilitation intervention (time frame: in the week after the last session of telerehabilitation training). The study lists 7 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 27 Apr 2022.