StrokeNCT01848080
A Randomized, Non-inferiority Clinical Trial of CVA Telerehabilitation Treatments - TelePhysioTaiChi
A study testing Tai Chi based exercise program in people with Stroke, run by Université de Sherbrooke at 3 sites in Canada.
Trial summary
Telerehabilitation is a promising alternative approach that can help improve access to rehabilitation services once patients are discharged home after stroke. The investigators therefore postulate a non-inferiority hypothesis of the telerehabilitation approach compared to home visits to improve balance problem related… Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Tai Chi based exercise program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 3 sitesCanada
- Study dates
- Jun 2013to 16 Sep 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- have had a stroke with a Rankin score of 2 or 3;
- was not referred to an Intensive Functional Rehabilitation Unit (IFRU) and returned home following discharge from hospital;
- understands instructions to allow participation in evaluations and interventions;
- has a balance problem as evidenced by a score between 46 and 54 on the Berg Balance Scale96;
- has a caregiver that would be available during the telerehabilitation sessions to ensure safety during exercises;
- live in an area serviced by high speed Internet.
Who cannot join
- severe body hemineglect;
- significant hemianopsia visual problems accompanied by hemineglect;
- uncontrolled medical problems;
- moderate to severe aphasia
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Hôpital Charles-LeMoyne
Longueuil
Centre de recherche interdisciplinaire en réadaptation du Montréal métropolitain
Montreal
Research Centre on Aging
Sherbrooke
About this study
Official title: A Tai Chi Based Exercise Program Provided Via Telerehabilitation Compared to During Home Visits in Persons Post-Stroke Who Have Returned Home Without Intensive Rehabilitation: A Randomized, Non-inferiority Clinical Trial
Telerehabilitation is a promising alternative approach that can help improve access to rehabilitation services once patients are discharged home after stroke. The investigators therefore postulate a non-inferiority hypothesis of the telerehabilitation approach compared to home visits to improve balance problem related to stroke. The platform used will be based on a technological infrastructure that was developed and tested in previous telerehabilitation studies. The study is a randomized control trial (RCT).The study population of interest will target individuals who have had a stroke who stayed in a hospital or chronic stroke population. Participants will be recruited during the hospitalization period at each of the three sites or in the community. The investigators expect to recruit 240 participants, 120 per group. The first evaluation will be conducted at recruitment to establish the baseline measures. The two other evaluations will be conducted 2 months (T2) and four months (T3) following recruitment.
- Conditions
- Stroke
- Being tested
- Tai Chi based exercise program
- Keywords
- Telemedicine, Telerehabilitation, Acute Stroke, Tai Chi, Tai Ji, Rehabilitation, Home care services, Single blind method, Randomized controlled trial
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tai Chi based exercise programBehavioural
A Tai Chi based exercise program that uses movement repetition favoring directional adjustments in space, supervised by a physiotherapist, has been shown to be effective in improving balance in individuals with physical impairments, including those presenting with sequelae following a stroke.
| Study group | Role | What they receive |
|---|---|---|
| Tai chi program via Telerehabilitation | Experimental | An individualized exercise program, based on Tai Chi, was developed by our team for previous studies aiming to improve balance in elderly, diabetic individuals and in frail, elderly individuals with balance problems. The exercise program consists of movements based on a combination of alignments and body-specific orientations, weight transfers and changes in direction inspired by Tai Chi. This group will receive this program via telerehabilitation. Receives: Behavioral: Tai Chi based exercise program |
| Tai chi program via home visits | Active comparator | An individualized exercise program, based on Tai Chi, was developed by our team for previous studies aiming to improve balance in elderly, diabetic individuals and in frail, elderly individuals with balance problems. The exercise program consists of movements based on a combination of alignments and body-specific orientations, weight transfers and changes in direction inspired by Tai Chi. This group will receive this program via home visits. Receives: Behavioral: Tai Chi based exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in mobility at 2 and 4 months
Community balance and mobility Scale.
Measured: before the intervention, month 2 and month 4
Change from baseline in Balance at 2 and 4 months
Community balance and mobility Scale.
Measured: before the intervention, month 2 and month 4
Secondary outcomes (9)
Change from baseline walking speed at 2 and 4 months
Speed: Timed up and go (TUG),
Measured: before the intervention, month 2, month 4
Change from baseline Psychological Attitudes related to balance at 2 and 4 months
Self efficacy: General Perceived Self efficacy
Measured: before the intervention, month 2, month 4
Change from baseline Quality of life at 2 and 4 month
Quality of life: Reintegration ti normal Living Index (RNLI)
Measured: before the intervention, month 2, month 4
Change from Baseline Satisfaction with the care received at 2 and 4 months
Satisfaction with the care received = Health care satisfaction questionnaire
Measured: before the intervention, month 2, month 4
Change from Baseline Cost of services from the perspective of the health system at 2 and 4 months
Cost of services from the perspective of the health system = "Cost-analysis of telemedicine" from the Minnesota University
Measured: before the intervention, month 2, month 4
Change from baseline walking endurance at 2 and 4 months
distance in meters walked two minutes
Measured: before the intervention, month 2 and month 4
Change from baseline aptitude for Balance at 2 and 4 months
Four-Squares Test
Measured: before the intervention, month 2 and month 4
Change from baseline Strength of lower limbs at 2 and 4 months
Sit to Stand Test
Measured: before the intervention, month 2 and month 4
Change from baseline Psychological Attitudes related to mobility at 2 and 4 months
fear of falling: Activities-specific Balance confidence scale
Measured: before the intervention, month 2, month 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2013 (estimated)
- Study startJun 2013
- Primary completion14 Jul 2021
- Study completion16 Sep 2021
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.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Collaborators
- Université de Montréal, University of Toronto
- Responsible party
- Principal investigator, Michel Tousignant, Université de Sherbrooke
- Investigators
- Michel Tousignant, PhD, Principal investigator, Research Centre on Aging
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01848080
- Sponsor's protocol ID
- 10-217-S1
- Status last verified
- Sep 2021
- First submitted
- 26 Apr 2013
- Last updated
- 28 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Tousignant M, Corriveau H, Kairy D, Berg K, Dubois MF, Gosselin S, Swartz RH, Boulanger JM, Danells C. Tai Chi-based exercise program provided via telerehabilitation compared to home visits in a post-stroke population who have returned home without intensive rehabilitation: study protocol for a randomized, non-inferiority clinical trial. Trials. 2014 Jan 30;15:42. doi: 10.1186/1745-6215-15-42.
PubMed 24479760
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Tai Chi Based Exercise Program Provided Via Telerehabilitation Compared to During Home Visits in Persons Post-Stroke Who Have Returned Home Without Intensive Rehabilitation: A Randomized, Non-inferiority Clinical Trial
- ClinicalTrials.gov ID
- NCT01848080
- Acronym / sponsor ID
- 10-217-S1
- Conditions
- Stroke
- Keywords
- Telemedicine, Telerehabilitation, Acute Stroke, Tai Chi, Tai Ji, Rehabilitation, Home care services, Single blind method
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Collaborators
- Université de Montréal, University of Toronto
- Study start
- Jun 2013 (actual)
- Primary completion
- 14 Jul 2021 (actual)
- Study completion
- 16 Sep 2021 (actual)
- First posted
- 7 May 2013 (estimated)
- 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.
Telerehabilitation is a promising alternative approach that can help improve access to rehabilitation services once patients are discharged home after stroke. The investigators therefore postulate a non-inferiority hypothesis of the telerehabilitation approach compared to home visits to improve balance problem related to stroke. The platform used will be based on a technological infrastructure that was developed and tested in previous telerehabilitation studies. The study is a randomized control trial (RCT).The study population of interest will target individuals who have had a stroke who stayed in a hospital or chronic stroke population. Participants will be recruited during the hospitalization period at each of the three sites or in the community. The investigators expect to recruit 240 participants, 120 per group. The first evaluation will be conducted at recruitment to establish the baseline measures. The two other evaluations will be conducted 2 months (T2) and four months (T3) following recruitment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tai chi program via Telerehabilitation | Experimental | Behavioral: Tai Chi based exercise programAn individualized exercise program, based on Tai Chi, was developed by our team for previous studies aiming to improve balance in elderly, diabetic individuals and in frail, elderly individuals with balance problems. The exercise program consists of movements based on a combination of alignments and body-specific orientations, weight transfers and changes in direction inspired by Tai Chi. This group will receive this program via telerehabilitation. |
| Tai chi program via home visits | Active comparator | Behavioral: Tai Chi based exercise programAn individualized exercise program, based on Tai Chi, was developed by our team for previous studies aiming to improve balance in elderly, diabetic individuals and in frail, elderly individuals with balance problems. The exercise program consists of movements based on a combination of alignments and body-specific orientations, weight transfers and changes in direction inspired by Tai Chi. This group will receive this program via home visits. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- have had a stroke with a Rankin score of 2 or 3;
- was not referred to an Intensive Functional Rehabilitation Unit (IFRU) and returned home following discharge from hospital;
- understands instructions to allow participation in evaluations and interventions;
- has a balance problem as evidenced by a score between 46 and 54 on the Berg Balance Scale96;
- has a caregiver that would be available during the telerehabilitation sessions to ensure safety during exercises;
Key exclusion criteria (4 listed)
- severe body hemineglect;
- significant hemianopsia visual problems accompanied by hemineglect;
- uncontrolled medical problems;
- moderate to severe aphasia
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 |
|---|---|---|
| Tai Chi based exercise programA Tai Chi based exercise program that uses movement repetition favoring directional adjustments in space, supervised by a physiotherapist, has been shown to be effective in improving balance in individuals with physical impairments, including those presenting with sequelae following a stroke. | Behavioural | Tai chi program via Telerehabilitation, Tai chi program via home visits |
Primary outcome
Change from baseline in mobility at 2 and 4 months
Time frame: before the intervention, month 2 and month 4
Community balance and mobility Scale.
Change from baseline in Balance at 2 and 4 months
Time frame: before the intervention, month 2 and month 4
Community balance and mobility Scale.
9 secondary outcomes
Change from baseline walking speed at 2 and 4 months
Time frame: before the intervention, month 2, month 4
Change from baseline Psychological Attitudes related to balance at 2 and 4 months
Time frame: before the intervention, month 2, month 4
Change from baseline Quality of life at 2 and 4 month
Time frame: before the intervention, month 2, month 4
Change from Baseline Satisfaction with the care received at 2 and 4 months
Time frame: before the intervention, month 2, month 4
Change from Baseline Cost of services from the perspective of the health system at 2 and 4 months
Time frame: before the intervention, month 2, month 4
Change from baseline walking endurance at 2 and 4 months
Time frame: before the intervention, month 2 and month 4
Change from baseline aptitude for Balance at 2 and 4 months
Time frame: before the intervention, month 2 and month 4
Change from baseline Strength of lower limbs at 2 and 4 months
Time frame: before the intervention, month 2 and month 4
Change from baseline Psychological Attitudes related to mobility at 2 and 4 months
Time frame: before the intervention, month 2, month 4
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 28 Sep 2021.
- Background: PubMed 24479760Tousignant M, Corriveau H, Kairy D, Berg K, Dubois MF, Gosselin S, Swartz RH, Boulanger JM, Danells C. Tai Chi-based exercise program provided via telerehabilitation compared to home visits in a post-stroke population who have returned home without intensive rehabilitation: study protocol for a randomized, non-inferiority clinical trial. Trials. 2014 Jan 30;15:42. doi: 10.1186/1745-6215-15-42.
- Complete and published research protocolLink provided by the sponsor.
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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.
Michel Tousignant, PhD principal investigator
Research Centre on Aging
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tai Chi based exercise program 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 6 inclusion and 4 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 28 Sep 2021. 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?
Change from baseline in mobility at 2 and 4 months (time frame: before the intervention, month 2 and month 4). The study lists 2 primary outcomes in all. 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 NCT01848080, 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 28 Sep 2021.