Stroke SequelaeNCT05595941
Tele-yoga in the Rehabilitation of Patients With Chronic Post-stroke Sequelae
A study testing tele-yoga in people with Stroke Sequelae, run by Hopital La Musse at 1 site in France.
Trial summary
Stroke is a major health problem and can cause long-term disability. Among these sequelae, there are balance and mobility disorders, but also a higher rate of anxiety or depression disorders. This impairments impact activity of daily living, and social reintegration. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke Sequelae
- What is being tested?
- tele-yoga
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2022to 1 Sep 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
- have had a stroke more than 6 months ago ;
- to have moderate balance problems (objectivity by a score between 41 and 51 on the Berg balance scale);
- to be able to stand and walk at least 10 meters, with or without technical assistance;
- to be able to get down and up from the floor independently,
- to have a caregiver present during the assessments, and designated as the "contact person" in case of problems during the tele-yoga sessions,
- to be equipped with a good quality internet connection and a computer tool allowing the use of Zoom software,
- and to be affiliated to a social security system.
Who cannot join
- be under 18 years of age;
- to suffer from cognitive disorders (score lower than 4 points on the 6-items Mini-Mental State Examination) preventing the comprehension of the instructions or to give his informed consent;
- to have a history of otolaryngological pathologies causing recurrent vertiginous syndromes;
- not being fluent in French (to the point of not being able to answer the questionnaires or understand the instructions);
- have a medical contraindication to physical activity;
- current and regular participation in another physical activity program;
- persons deprived of liberty by a judicial or administrative decision, persons under psychiatric care, as well as adults under legal protection (guardianship, curatorship and safeguard of justice), pregnant women, women in labour and breastfeeding women, referred to in articles L.1121-5 to 8 of the french public health code.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Tele-yoga in the Rehabilitation of Patients With Chronic Post-stroke Sequelae : a Pilot Randomized Controlled Trial
Stroke is a major health problem and can cause long-term disability. Among these sequelae, there are balance and mobility disorders, but also a higher rate of anxiety or depression disorders. This impairments impact activity of daily living, and social reintegration. That why the investigators need to explore options for long-term sustainable interventions that which takes into account the patient as a whole. In particular, regular physical activity is recommended, but it must be adaptable to the patient's impairments. Teaching yoga may be an interesting option. Indeed, yoga is a mind-body practice which become increasingly widespread in the world. Recent studies highlight positive effect of yoga for this population. However, accessibility to yoga classes can be limited by many factors: lack of transportation, lack of available health professionals, confinement requirements... Therefore, it seems relevant to evaluate the effectiveness of yoga delivered through tele-rehabilitation.
The main objective of this study is to evaluate the effectiveness of a tele-yoga program adapted to stroke survivors to improve their functional balance.
The secondary objectives are to evaluate the effectiveness of the adapted tele-yoga program in improving functional mobility, anxiety, depression and reintegration into normal life.
Read the detailed description
The investigators will conduct a single-blind randomised controlled trial to study the effectiveness of a tele-yoga programme compared to an inactive control group in improving balance in chronic post-stroke subjects. The primary hypothesis is that yoga is effective in improving balance in chronic post-stroke patients. The secondary hypothesis is that yoga is effective in improving functional mobility, anxiety, depression, and reintegration into normal life.
The experiment will take place in metropolitan France, and the whole experimental procedure (recruitment, evaluation, experimentation) will take place at a distance, via information and communication technologies. The statistical power study indicates that 15 patients per group would be required. Subjects will be randomly assigned to one of the following groupe: the TELEYOG'AVC programme or the inactive control group. The TELEYOG'AVC programme will involve yoga sessions with postural, respiratory, and meditative work delivered by videoconference. This programme includes two 60-minute group sessions per week, for 12 weeks, plus one weekly home-based session (with video support). The control group will be instructed not to change their habits during the 12 weeks of experimentation, then after the final assessment (T1) they will be able to benefit from the TELEYOG'AVC programme if they want. Patients will be assessed before the experiment (T0) and after the 12-week experiment (T1). The assessments will be carried out blind, using a protocol built around the International Classification of Functioning and Disability (ICF). The main criterion is balance, assessed by the Berg balance scale (0-56 point scale). The secondary outcomes will be assessed by: Timed Up and Go Test (timed task in seconds), 5 time-sit-to-stand (timed task in seconds), the activities-specific Balance Confidence Scale - Simplified (questionnaire in %), State-Trait Anxiety Inventory (2 questionnaires out of 80), Beck Depression Inventory (score out of 63), Reintegration to Normal Living Index (score out of 22). Adherence to the programme will be assessed between T0 and T1 by the number of group and individual sessions completed.
- Conditions
- Stroke Sequelae
- Being tested
- tele-yoga
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tele-yogaOther
Each session will include postural exercises (asanas), standing, sitting and lying down, in order to work on balance, muscular strength and endurance, as well as flexibility. They will be adapted to the physical possibilities of the patients with the help of accessories such as chairs, straps, cushions, blocks (provided free to each participant). In addition, breathing work will accompany these postures. A relaxing passive meditation is practiced at the end of each session, in a lying posture called "Savasana". The complexity of the postures, their holding time, or the number of repetitions will increase as the program progresses, relative to the abilities of each participant.
| Study group | Role | What they receive |
|---|---|---|
| TELEYOG'AVC Group | Experimental | The subjects of the experimental group will be invited to participate in 60-minute tele-yoga sessions, twice a week, for 12 weeks. The sessions will take place via the Zoom videoconference software, in small groups (maximum 5 people) in order to adapt the practice to the possibilities of each subject. In addition, an additional weekly session, independently at home, will be recommended to participants, accompanied by a pre-recorded video support hosted on YouTube. Receives: Other: tele-yoga |
| Wainting list Group | No intervention | The subjects in the control group will be asked not to change their habits during the entire experimental phase (T0-T1). They will be able to benefit in turn from the tele-yoga program (free of charge), if they wish, once the evaluations in T1 are completed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Berg balance scale
This test quantitatively assesses balance in adults. In this 14-item scale, patients are asked to maintain positions and perform movement tasks of varying difficulty. Patients are given a score between 0 and 4 on their ability to respond to dimensions of balance. An overall score can be calculated from a total of 56. The higher the score, the better the balance.
Measured: Pre-treatment
Berg balance scale
This test quantitatively assesses balance in adults. In this 14-item scale, patients are asked to maintain positions and perform movement tasks of varying difficulty. Patients are given a score between 0 and 4 on their ability to respond to dimensions of balance. An overall score can be calculated from a total of 56. The higher the score, the better the balance.
Measured: Pre-treatment : at three months
Secondary outcomes (12)
Timed Up and Go Test
It is a test based on the realization of a functional task, where the subject must get up from a chair, walk 3 meters, turn around and return to sit down. The subject is timed during the execution and a score in seconds is established.
Measured: Pre-treatment
Timed Up and Go Test
It is a test based on the realization of a functional task, where the subject must get up from a chair, walk 3 meters, turn around and return to sit down. The subject is timed during the execution and a score in seconds is established.
Measured: Pre-treatment : at three months
Five Times Sit to Stand
It's a test based on the realization of a functional task: the subject must stand up and sit back down on a chair without armrest. He must perform this task five times in a row, and he is timed to obtain a score in seconds.
Measured: Pre-treatment
Five Times Sit to Stand
It's a test based on the realization of a functional task: the subject must stand up and sit back down on a chair without armrest. He must perform this task five times in a row, and he is timed to obtain a score in seconds.
Measured: Pre-treatment : at three months
Activities-specific Balance Confidence Scale - Simplified
This questionnaire consists of 16 questions that require the patient to rate his or her confidence that he or she will not lose balance while performing the listed activities. For each of the 16 activities, he/she must rate this confidence from 0 (not at all confident) to 3 (very confident). The total score is given as a percentage.
Measured: Pre-treatment
Activities-specific Balance Confidence Scale - Simplified
This questionnaire consists of 16 questions that require the patient to rate his or her confidence that he or she will not lose balance while performing the listed activities. For each of the 16 activities, he/she must rate this confidence from 0 (not at all confident) to 3 (very confident). The total score is given as a percentage.
Measured: Pre-treatment : at three months
State-Trait Anxiety Inventory
t includes two separate (self-administered) scales to assess state anxiety (STAY Form Y-A), and treatment anxiety (STAY Form Y-B). Each of the scales consists of 20 propositions, Scale A to assess how subjects feel in the moment, Scale B to capture how subjects generally feel. Each answer to a proposition of the questionnaire corresponds to a score from 1 to 4: 1 indicating the lowest degree of anxiety, 4 the highest degree. A total score is given out of 80.
Measured: Pre-treatment
State-Trait Anxiety Inventory
t includes two separate (self-administered) scales to assess state anxiety (STAY Form Y-A), and treatment anxiety (STAY Form Y-B). Each of the scales consists of 20 propositions, Scale A to assess how subjects feel in the moment, Scale B to capture how subjects generally feel. Each answer to a proposition of the questionnaire corresponds to a score from 1 to 4: 1 indicating the lowest degree of anxiety, 4 the highest degree. A total score is given out of 80.
Measured: Pre-treatment : at three months
Beck Depression Inventory
This self-administered questionnaire includes 21 items identifying symptoms and attitudes associated with depression. Each item is rated on a severity scale ranging from 0 to 3, with a total score ranging from 0 to 63.
Measured: Pre-treatment
Beck Depression Inventory
This self-administered questionnaire includes 21 items identifying symptoms and attitudes associated with depression. Each item is rated on a severity scale ranging from 0 to 3, with a total score ranging from 0 to 63.
Measured: Pre-treatment : at three months
Reintegration to Normal Living Index
This questionnaire is composed of 11 declarative statements accompanied by a 3-point rating. The scores of each individual item are added together to obtain a total score ranging from 0 to 22 points, with higher scores indicating worse reintegration.
Measured: Pre-treatment
Reintegration to Normal Living Index
This questionnaire is composed of 11 declarative statements accompanied by a 3-point rating. The scores of each individual item are added together to obtain a total score ranging from 0 to 22 points, with higher scores indicating worse reintegration.
Measured: Pre-treatment : at three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2022
- Study start1 Oct 2022
- Primary completion1 Apr 2023
- Study completion1 Sep 2023
Why it stopped: The planned recruitment and treatment period was limited by the financial resources allocated to the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke SequelaeStudies 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
- Model description
- This is a single-blind pilot randomised controlled trial.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital La Musse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Charlotte Menez, PhD, Principal investigator, Hôpital La Musse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05595941
- Sponsor's protocol ID
- 2022-A00929-34
- Status last verified
- Nov 2023
- First submitted
- 28 Sep 2022
- Last updated
- 21 Nov 2023
- 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 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Tele-yoga in the Rehabilitation of Patients With Chronic Post-stroke Sequelae : a Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05595941
- Acronym / sponsor ID
- 2022-A00929-34
- Conditions
- Stroke Sequelae
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The planned recruitment and treatment period was limited by the financial resources allocated to the study.
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Hopital La MusseUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 Apr 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 27 Oct 2022 (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 major health problem and can cause long-term disability. Among these sequelae, there are balance and mobility disorders, but also a higher rate of anxiety or depression disorders. This impairments impact activity of daily living, and social reintegration. That why the investigators need to explore options for long-term sustainable interventions that which takes into account the patient as a whole. In particular, regular physical activity is recommended, but it must be adaptable to the patient's impairments. Teaching yoga may be an interesting option. Indeed, yoga is a mind-body practice which become increasingly widespread in the world. Recent studies highlight positive effect of yoga for this population. However, accessibility to yoga classes can be limited by many factors: lack of transportation, lack of available health professionals, confinement requirements... Therefore, it seems relevant to evaluate the effectiveness of yoga delivered through tele-rehabilitation.
The main objective of this study is to evaluate the effectiveness of a tele-yoga program adapted to stroke survivors to improve their functional balance.
The secondary objectives are to evaluate the effectiveness of the adapted tele-yoga program in improving functional mobility, anxiety, depression and reintegration into normal life.
Detailed description
The investigators will conduct a single-blind randomised controlled trial to study the effectiveness of a tele-yoga programme compared to an inactive control group in improving balance in chronic post-stroke subjects. The primary hypothesis is that yoga is effective in improving balance in chronic post-stroke patients. The secondary hypothesis is that yoga is effective in improving functional mobility, anxiety, depression, and reintegration into normal life.
The experiment will take place in metropolitan France, and the whole experimental procedure (recruitment, evaluation, experimentation) will take place at a distance, via information and communication technologies. The statistical power study indicates that 15 patients per group would be required. Subjects will be randomly assigned to one of the following groupe: the TELEYOG'AVC programme or the inactive control group. The TELEYOG'AVC programme will involve yoga sessions with postural, respiratory, and meditative work delivered by videoconference. This programme includes two 60-minute group sessions per week, for 12 weeks, plus one weekly home-based session (with video support). The control group will be instructed not to change their habits during the 12 weeks of experimentation, then after the final assessment (T1) they will be able to benefit from the TELEYOG'AVC programme if they want. Patients will be assessed before the experiment (T0) and after the 12-week experiment (T1). The assessments will be carried out blind, using a protocol built around the International Classification of Functioning and Disability (ICF). The main criterion is balance, assessed by the Berg balance scale (0-56 point scale). The secondary outcomes will be assessed by: Timed Up and Go Test (timed task in seconds), 5 time-sit-to-stand (timed task in seconds), the activities-specific Balance Confidence Scale - Simplified (questionnaire in %), State-Trait Anxiety Inventory (2 questionnaires out of 80), Beck Depression Inventory (score out of 63), Reintegration to Normal Living Index (score out of 22). Adherence to the programme will be assessed between T0 and T1 by the number of group and individual sessions completed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is a single-blind pilot randomised controlled trial.
| Arm | Type | Receives |
|---|---|---|
| TELEYOG'AVC Group | Experimental | Other: tele-yogaThe subjects of the experimental group will be invited to participate in 60-minute tele-yoga sessions, twice a week, for 12 weeks. The sessions will take place via the Zoom videoconference software, in small groups (maximum 5 people) in order to adapt the practice to the possibilities of each subject. In addition, an additional weekly session, independently at home, will be recommended to participants, accompanied by a pre-recorded video support hosted on YouTube. |
| Wainting list Group | No intervention | –The subjects in the control group will be asked not to change their habits during the entire experimental phase (T0-T1). They will be able to benefit in turn from the tele-yoga program (free of charge), if they wish, once the evaluations in T1 are completed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- have had a stroke more than 6 months ago ;
- to have moderate balance problems (objectivity by a score between 41 and 51 on the Berg balance scale);
- to be able to stand and walk at least 10 meters, with or without technical assistance;
- to be able to get down and up from the floor independently,
- to have a caregiver present during the assessments, and designated as the "contact person" in case of problems during the tele-yoga sessions,
Key exclusion criteria (7 listed)
- be under 18 years of age;
- to suffer from cognitive disorders (score lower than 4 points on the 6-items Mini-Mental State Examination) preventing the comprehension of the instructions or to give his informed consent;
- to have a history of otolaryngological pathologies causing recurrent vertiginous syndromes;
- not being fluent in French (to the point of not being able to answer the questionnaires or understand the instructions);
- have a medical contraindication to physical activity;
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 |
|---|---|---|
| tele-yogaEach session will include postural exercises (asanas), standing, sitting and lying down, in order to work on balance, muscular strength and endurance, as well as flexibility. They will be adapted to the physical possibilities of the patients with the help of accessories such as chairs, straps, cushions, blocks (provided free to each participant). In addition, breathing work will accompany these postures. A relaxing passive meditation is practiced at the end of each session, in a lying posture called "Savasana". The complexity of the postures, their holding time, or the number of repetitions will increase as the program progresses, relative to the abilities of each participant. | Other | TELEYOG'AVC Group |
Primary outcome
Berg balance scale
Time frame: Pre-treatment
This test quantitatively assesses balance in adults. In this 14-item scale, patients are asked to maintain positions and perform movement tasks of varying difficulty. Patients are given a score between 0 and 4 on their ability to respond to dimensions of balance. An overall score can be calculated from a total of 56. The higher the score, the better the balance.
Berg balance scale
Time frame: Pre-treatment : at three months
This test quantitatively assesses balance in adults. In this 14-item scale, patients are asked to maintain positions and perform movement tasks of varying difficulty. Patients are given a score between 0 and 4 on their ability to respond to dimensions of balance. An overall score can be calculated from a total of 56. The higher the score, the better the balance.
12 secondary outcomes
Timed Up and Go Test
Time frame: Pre-treatment
Timed Up and Go Test
Time frame: Pre-treatment : at three months
Five Times Sit to Stand
Time frame: Pre-treatment
Five Times Sit to Stand
Time frame: Pre-treatment : at three months
Activities-specific Balance Confidence Scale - Simplified
Time frame: Pre-treatment
Activities-specific Balance Confidence Scale - Simplified
Time frame: Pre-treatment : at three months
State-Trait Anxiety Inventory
Time frame: Pre-treatment
State-Trait Anxiety Inventory
Time frame: Pre-treatment : at three months
Beck Depression Inventory
Time frame: Pre-treatment
Beck Depression Inventory
Time frame: Pre-treatment : at three months
Reintegration to Normal Living Index
Time frame: Pre-treatment
Reintegration to Normal Living Index
Time frame: Pre-treatment : at three months
Results and safety
The study was stopped early (reason given: The planned recruitment and treatment period was limited by the financial resources allocated to the study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2023.
- 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.
Charlotte Menez, PhD principal investigator
Hôpital La Musse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tele-yoga in people with Stroke Sequelae, run by Hopital La Musse at 1 site in France.
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 7 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: stopped early, as of the sponsor's last update on 21 Nov 2023. 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 France. 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 was stopped early (reason given: The planned recruitment and treatment period was limited by the financial resources allocated to the study.). Results are not available in the source record.
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?
Berg balance scale (time frame: Pre-treatment). 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?
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 21 Nov 2023.