StrokeHEMI'DANCENCT04120467
Dance as a Means to Improve Functions and Quality of Life After a Stroke
A study testing Dance and Standard rehabilitation in people with Stroke, run by Anne-Violette Bruynnel at 1 site in Switzerland.
Trial summary
Context Dance is an intrinsically motivating activity comprising social interaction, stimulation through music, the joy of moving despite motor limitations induced by pathology, and which has good perceived benefits among participants. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- Dance and Standard rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteSwitzerland
- Study dates
- 3 Feb 2020to 7 Mar 2022
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Post stroke
- Subacute phase
- Able to endure 60 minutes of physical activity
- Medical stability
- Able to understand the consign
Who cannot join
- Medical complications
- Hearing disorders
- Previous pathologies associated with balance disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dance After a Stroke to Restore Pleasure in Physical Activity to Improve Cognitive and Motor Functions, Quality of Life and Well-being
Context Dance is an intrinsically motivating activity comprising social interaction, stimulation through music, the joy of moving despite motor limitations induced by pathology, and which has good perceived benefits among participants. Moving with pleasure is essential to finding the motivation to engage in rehabilitation program and physical activity. In stroke context, physical activity and rehabilitation were difficult to carry out because of cognitive and motor disabilities. Moreover, when the rehabilitation is over, the diminishing motor stimulation gradually limits autonomy in daily tasks. It is therefore urgent to provide persons in a post-stroke situation with motivating physical activity opportunities. Very few studies have studied dance in a context of stroke, while this physical activity is highly adapted and effective for other chronic conditions.
Objectives: The main objective is to assess the effects of dance practice on cognitive and motor functions for persons after stroke. The secondary objective is to investigate the effects of dance on quality of life, motivation and adherence. The investigator's hypothesis is that the practice of dance induces an increase of balance and motor capacities, and improving the quality of life, adherence and motivation after a stroke.
Read more
Materials and method :
Forty-eight subjects with stroke in subacute phase will be randomized into two groups: 1) intervention (dance and standard rehabilitation) and 2) control (standard rehabilitation). Before intervention, stroke severity, cognitive abilities and motor capacities will be tested. Two baseline tests will occur to assess the stability of individuals will be planned. Participants will attend a dance class weekly during 6 weeks. The cognitive and motor functions (balance, lower-limbs strength, coordination and motor level), the quality of life (Stroke-specific quality of life scale) will be measured at 4 and 6 weeks in both groups. Participant satisfaction with regard to dance will be tested, as well as adherence and adverse effects.
Perspectives:
The joy of dancing and the possibility of including other non-disabled people should facilitate adherence and motivation and increase the recovery of cognitive and motor functions.This project should motivate physiotherapists and dance teachers to increase the offer of dance classes for persons with motor and cognitive impairments.This action will be a basis for combating people's sedentary lifestyle after a stroke.
- Conditions
- Stroke
- Being tested
- Dance, Standard rehabilitation
- Keywords
- Stroke, Rehabilitation, Dance
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DanceOther
One group will receive a 60-minute dance class weekly over a 6 weeks period. A physiotherapist - dance teacher will lead the classes, supported by at least one volunteer.
The class structure will consist of five components: warm up (10 minutes), technical exercises (10 minutes), improvisation (15 minutes), a short routine (15 minutes) and a cool down/feedback time (10 minutes). Dance exercises will be targeting flexibility, balance, endurance, upper and lower limbs functions, interaction between dancers, perception and memory. Using choreography or short routine, the class will include repeating the dance moves - which fosters memorization - and also the additional challenge of remembering a sequence of moves.
Given the great variability of each participant's functional ability, the complexity and the intensity of the dance exercises will progress according to each participant's capacity, in order to fulfill an appropriate challenge at moderate treatment intensity.
Standard rehabilitationOther
The control group will have conventional rehabilitation as usually planned in the rehabilitation center: 45 to 60 minutes of physiotherapy per day integrating sensory stimulation, motor activation, strengthening, coordination, balance and exercise training. Patients also receive 45 to 60 minutes of occupational therapy per day.
| Study group | Role | What they receive |
|---|---|---|
| Dance | Experimental | Dance Standard rehabilitation post-stroke Receives: Other: Dance; Other: Standard rehabilitation |
| Control | Active comparator | Standard rehabilitation post-stroke Receives: Other: Standard rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline cognitive-motor functions in both groups (dance vs. control): cognitive recovery
The cognitive function will be measured with the Montreal Cognitive Assessement scale.There are 12 items for cognitive domains: memory is tested by a short-term memory recall task (5 points); visuospatial ability is tested using a clock-drawing test (3 points) and a 3-dimensional cube copy (1 point); executive function is tested using a trail-making test (1 point), a phonemic fluency task (1 point), and a 2-item verbal abstraction task (2 points); attention, concentration, and working memory is tested using a attention task (1 point), a serial subtraction task (3 points), and digits tasks (1 point each); language is tested using a 3-item confrontation naming task with animals (3 points) and repetition of 2 syntactically complex sentences (2 points); orientation in time and place was also tested (6 points).
The minimum score is 0 and the maximum score is 30. Higher scores indicate better cognition. Normal score: >26/30.
Measured: 6 weeks
Change from baseline cognitive-motor functions in both groups (dance vs. control): balance recovery
The balance will be measured with Balance Evaluation System test (miniBest test).
The test has a maximum score of 28 points from 14 items that are each scored from 0-2. "0" indicates the lowest level of function and "2" the highest level of function. The minimum score is "0" and maximum score is "28".
Measured: 4 weeks and 6 weeks
Change from baseline cognitive-motor functions in both groups (dance vs. control): standing balance recovery
The standing balance will be tested in bipedal condition in single task and dual-task (with phone text task) with inertial sensor. Parameters: displacement in anteroposterior and mediolateral directions (in mm).
Measured: 4 weeks and 6 weeks
Change from baseline cognitive-motor functions in both groups (dance vs. control): balance confidence recovery
The balance confidence will be measured with the Activities-Specific Balance Confidence scale (ABC-scale).
The ABC-scale is a self-reported questionnaire providing information on balance confidence in the performance of 16 different daily activities, such as stair climbing, walking in the house, and walking on slippery floors. The questionnaire contains 16 items scored on a range from 0% to 100% (0 indicating no confidence and 100 indicating full confidence). The total ABC scale score of ≤67 indicates an increased risk of fall.
Measured: 4 weeks and 6 weeks
Change from baseline cognitive-motor functions in both groups (dance vs. control): lower limbs muscle strength recovery
The knee extensors muscle strength will be measured with an hand-held dynamometer in Newton (N).
Measured: 4 weeks and 6 weeks
Change from baseline cognitive-motor functions in both groups (dance vs. control): coordination recovery
The coordination will be tested using the Lower Extremity Motor Coordination (LEMOCOT) test.
The subject will be sat on an adjustable chair with their feet resting flat on thin rigid foam, heels on the proximal target, and with knees and hips at 90° of flexion. Then, after a familiarization trial, they will instructed to alternately touch the proximal and distal targets, placed 30cm apart, with their big toe, for 20s, as fast as possible, without sacrificing the accuracy to increase speed. The number of touched targets will be counted and registered for analyses.
Measured: 4 weeks and 6 weeks
Change from baseline cognitive-motor functions in both groups (dance vs. control): functional ability recovery
Motor level will be assessed with a Functional Independence Measure Instrument (MIF). Motor level will be assessed with a Functional Independence Measure Instrument. The scale contains 18 items, of which 13 items are in physical domains and 5 items are related to cognition. Motor items measure self-care, sphincter control, locomotion, and transfer. Cognitive ones evaluate subject's communication and social cognition. Based on level of independence, each item is scored from 1 to 7, where 1 indicates total dependence and 7 represents complete independence. Possible scores range from 18 to 126. Higher values represent a better outcome.
Measured: 6 weeks
Secondary outcomes (4)
Change from baseline Quality of life in both groups (dance vs. control)
The quality of life of persons with chronic strokes will be measured using the Stroke-specific quality of life scale (SS-QoL).
The SS-QOL contains 12 subscales with a total of 49 items. Scoring of the SS-QOL concerns the past week and is rated on a 5-point Likert scale. Response options are scored as 5 ("no help needed/no trouble at all/strongly disagree"), 4 ("a little help/a little trouble/moderately disagree"), 3 ("some help/some trouble/neither agree nor disagree"), 2 ("a lot of help/a lot of trouble/moderately agree"), and 1 ("total help/could not do it at all/strongly agree"). The SS-QOL provides domain scores and a summary score, with higher scores indicating better function. The total score is calculated by averaging the domain scores. The minimum score is 12 and the maximum score is 245.
Measured: 6 weeks
Change from baseline Motivation for Physical Activity practice in both groups (dance vs. control)
A motivation scale towards health-oriented physical activity. The motivation scale towards health-oriented physical activity (MS-PA) contains a total of 18 items. Scoring is rated on 7-point scale (1 = " strongly disagree " and 7 = " strongly agree "). The minimum score = 18 and maximum score = 126. Higher values represent a worse motivation.
Measured: 4 weeks and 6 weeks
Incidence of dance practice on adverse effects: existence of pain and fatigue after each dance class
The pain and fatigue will be measured with numeric rating scale (NRS). The 11-point numeric scale ranges from '0' representing one extreme (e.g. "no pain" or "no fatigue) to '10' representing the other extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable" or "worst fatigue imaginable"). Scores range from 0-10 points, with higher scores indicating greater pain or fatigue intensity.
Measured: up to 6 weeks (after each dance class)
Level of participant's satisfaction with dance class
Participant satisfaction assessed with an exit survey adapted from a previous study report that investigated dance for a person with chronic stroke. The survey asked participants to rate nine statements about the dance program using a 5-point scale (where 1 = "strongly disagree" and 5 = "strongly agree"). Higher values represent a better satisfaction.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2019
- Study start3 Feb 2020
- Primary completion7 Mar 2022
- Study completion7 Mar 2022
Why it stopped: Difficulty of recruitment following COVID-19. Decision to stop the study of the rehabilitation center.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anne-Violette Bruynnel
- Sponsor type
- University, hospital or other
- Collaborators
- Institution de Lavigny
- Responsible party
- Sponsor-investigator, Anne-Violette Bruynnel, School of Health Sciences Geneva
- Investigators
- Anne-Violette Bruyneel, Principal investigator, Haute Ecole de Santé de Genève (SchoolHSG)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04120467
- Sponsor's protocol ID
- SchoolHSG
- Acronym
- HEMI'DANCE
- Status last verified
- Mar 2022
- First submitted
- 2 Oct 2019
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data for all primary and secondary outcome measure will be made available.
Publications
Bruyneel AV. Effects of dance activities on patients with chronic pathologies: scoping review. Heliyon. 2019 Jul 20;5(7):e02104. doi: 10.1016/j.heliyon.2019.e02104. eCollection 2019 Jul.
PubMed 31372555Patterson KK, Wong JS, Nguyen TU, Brooks D. A dance program to improve gait and balance in individuals with chronic stroke: a feasibility study. Top Stroke Rehabil. 2018 Sep;25(6):410-416. doi: 10.1080/10749357.2018.1469714. Epub 2018 May 10.
PubMed 29745307Patterson KK, Wong JS, Prout EC, Brooks D. Dance for the rehabilitation of balance and gait in adults with neurological conditions other than Parkinson's disease: A systematic review. Heliyon. 2018 Mar 29;4(3):e00584. doi: 10.1016/j.heliyon.2018.e00584. eCollection 2018 Mar.
PubMed 29862347Demers M, McKinley P. Feasibility of delivering a dance intervention for subacute stroke in a rehabilitation hospital setting. Int J Environ Res Public Health. 2015 Mar 16;12(3):3120-32. doi: 10.3390/ijerph120303120.
PubMed 25785497Morice E, Moncharmont J, Jenny C, Bruyneel AV. Dancing to improve balance control, cognitive-motor functions and quality of life after stroke: a study protocol for a randomised controlled trial. BMJ Open. 2020 Sep 30;10(9):e037039. doi: 10.1136/bmjopen-2020-037039.
PubMed 32998921
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dance After a Stroke to Restore Pleasure in Physical Activity to Improve Cognitive and Motor Functions, Quality of Life and Well-being
- ClinicalTrials.gov ID
- NCT04120467
- Acronym / sponsor ID
- HEMI'DANCE / SchoolHSG
- Conditions
- Stroke
- Keywords
- Stroke, Rehabilitation, Dance
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty of recruitment following COVID-19. Decision to stop the study of the rehabilitation center.
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Anne-Violette BruynnelUniversity, hospital or other
- Collaborators
- Institution de Lavigny
- Study start
- 3 Feb 2020 (actual)
- Primary completion
- 7 Mar 2022 (actual)
- Study completion
- 7 Mar 2022 (actual)
- First posted
- 9 Oct 2019 (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.
Context Dance is an intrinsically motivating activity comprising social interaction, stimulation through music, the joy of moving despite motor limitations induced by pathology, and which has good perceived benefits among participants. Moving with pleasure is essential to finding the motivation to engage in rehabilitation program and physical activity. In stroke context, physical activity and rehabilitation were difficult to carry out because of cognitive and motor disabilities. Moreover, when the rehabilitation is over, the diminishing motor stimulation gradually limits autonomy in daily tasks. It is therefore urgent to provide persons in a post-stroke situation with motivating physical activity opportunities. Very few studies have studied dance in a context of stroke, while this physical activity is highly adapted and effective for other chronic conditions.
Objectives: The main objective is to assess the effects of dance practice on cognitive and motor functions for persons after stroke. The secondary objective is to investigate the effects of dance on quality of life, motivation and adherence. The investigator's hypothesis is that the practice of dance induces an increase of balance and motor capacities, and improving the quality of life, adherence and motivation after a stroke.
Materials and method :
Forty-eight subjects with stroke in subacute phase will be randomized into two groups: 1) intervention (dance and standard rehabilitation) and 2) control (standard rehabilitation). Before intervention, stroke severity, cognitive abilities and motor capacities will be tested. Two baseline tests will occur to assess the stability of individuals will be planned. Participants will attend a dance class weekly during 6 weeks. The cognitive and motor functions (balance, lower-limbs strength, coordination and motor level), the quality of life (Stroke-specific quality of life scale) will be measured at 4 and 6 weeks in both groups. Participant satisfaction with regard to dance will be tested, as well as adherence and adverse effects.
Perspectives:
The joy of dancing and the possibility of including other non-disabled people should facilitate adherence and motivation and increase the recovery of cognitive and motor functions.This project should motivate physiotherapists and dance teachers to increase the offer of dance classes for persons with motor and cognitive impairments.This action will be a basis for combating people's sedentary lifestyle after a stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dance | Experimental | Other: Dance, Other: Standard rehabilitationDance Standard rehabilitation post-stroke |
| Control | Active comparator | Other: Standard rehabilitationStandard rehabilitation post-stroke |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Post stroke
- Subacute phase
- Able to endure 60 minutes of physical activity
- Medical stability
- Able to understand the consign
Key exclusion criteria (3 listed)
- Medical complications
- Hearing disorders
- Previous pathologies associated with balance disorders
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 |
|---|---|---|
| DanceOne group will receive a 60-minute dance class weekly over a 6 weeks period. A physiotherapist - dance teacher will lead the classes, supported by at least one volunteer. The class structure will consist of five components: warm up (10 minutes), technical exercises (10 minutes), improvisation (15 minutes), a short routine (15 minutes) and a cool down/feedback time (10 minutes). Dance exercises will be targeting flexibility, balance, endurance, upper and lower limbs functions, interaction between dancers, perception and memory. Using choreography or short routine, the class will include repeating the dance moves - which fosters memorization - and also the additional challenge of remembering a sequence of moves. Given the great variability of each participant's functional ability, the complexity and the intensity of the dance exercises will progress according to each participant's capacity, in order to fulfill an appropriate challenge at moderate treatment intensity. | Other | Dance |
| Standard rehabilitationThe control group will have conventional rehabilitation as usually planned in the rehabilitation center: 45 to 60 minutes of physiotherapy per day integrating sensory stimulation, motor activation, strengthening, coordination, balance and exercise training. Patients also receive 45 to 60 minutes of occupational therapy per day. | Other | Control, Dance |
Primary outcome
Change from Baseline cognitive-motor functions in both groups (dance vs. control): cognitive recovery
Time frame: 6 weeks
The cognitive function will be measured with the Montreal Cognitive Assessement scale.There are 12 items for cognitive domains: memory is tested by a short-term memory recall task (5 points); visuospatial ability is tested using a clock-drawing test (3 points) and a 3-dimensional cube copy (1 point); executive function is tested using a trail-making test (1 point), a phonemic fluency task (1 point), and a 2-item verbal abstraction task (2 points); attention, concentration, and working memory is tested using a attention task (1 point), a serial subtraction task (3 points), and digits tasks (1 point each); language is tested using a 3-item confrontation naming task with animals (3 points) and repetition of 2 syntactically complex sentences (2 points); orientation in time and place was also tested (6 points). The minimum score is 0 and the maximum score is 30. Higher scores indicate better cognition. Normal score: >26/30.
Change from baseline cognitive-motor functions in both groups (dance vs. control): balance recovery
Time frame: 4 weeks and 6 weeks
The balance will be measured with Balance Evaluation System test (miniBest test). The test has a maximum score of 28 points from 14 items that are each scored from 0-2. "0" indicates the lowest level of function and "2" the highest level of function. The minimum score is "0" and maximum score is "28".
Change from baseline cognitive-motor functions in both groups (dance vs. control): standing balance recovery
Time frame: 4 weeks and 6 weeks
The standing balance will be tested in bipedal condition in single task and dual-task (with phone text task) with inertial sensor. Parameters: displacement in anteroposterior and mediolateral directions (in mm).
Change from baseline cognitive-motor functions in both groups (dance vs. control): balance confidence recovery
Time frame: 4 weeks and 6 weeks
The balance confidence will be measured with the Activities-Specific Balance Confidence scale (ABC-scale). The ABC-scale is a self-reported questionnaire providing information on balance confidence in the performance of 16 different daily activities, such as stair climbing, walking in the house, and walking on slippery floors. The questionnaire contains 16 items scored on a range from 0% to 100% (0 indicating no confidence and 100 indicating full confidence). The total ABC scale score of ≤67 indicates an increased risk of fall.
Change from baseline cognitive-motor functions in both groups (dance vs. control): lower limbs muscle strength recovery
Time frame: 4 weeks and 6 weeks
The knee extensors muscle strength will be measured with an hand-held dynamometer in Newton (N).
Change from baseline cognitive-motor functions in both groups (dance vs. control): coordination recovery
Time frame: 4 weeks and 6 weeks
The coordination will be tested using the Lower Extremity Motor Coordination (LEMOCOT) test. The subject will be sat on an adjustable chair with their feet resting flat on thin rigid foam, heels on the proximal target, and with knees and hips at 90° of flexion. Then, after a familiarization trial, they will instructed to alternately touch the proximal and distal targets, placed 30cm apart, with their big toe, for 20s, as fast as possible, without sacrificing the accuracy to increase speed. The number of touched targets will be counted and registered for analyses.
Change from baseline cognitive-motor functions in both groups (dance vs. control): functional ability recovery
Time frame: 6 weeks
Motor level will be assessed with a Functional Independence Measure Instrument (MIF). Motor level will be assessed with a Functional Independence Measure Instrument. The scale contains 18 items, of which 13 items are in physical domains and 5 items are related to cognition. Motor items measure self-care, sphincter control, locomotion, and transfer. Cognitive ones evaluate subject's communication and social cognition. Based on level of independence, each item is scored from 1 to 7, where 1 indicates total dependence and 7 represents complete independence. Possible scores range from 18 to 126. Higher values represent a better outcome.
4 secondary outcomes
Change from baseline Quality of life in both groups (dance vs. control)
Time frame: 6 weeks
Change from baseline Motivation for Physical Activity practice in both groups (dance vs. control)
Time frame: 4 weeks and 6 weeks
Incidence of dance practice on adverse effects: existence of pain and fatigue after each dance class
Time frame: up to 6 weeks (after each dance class)
Level of participant's satisfaction with dance class
Time frame: 6 weeks
Results and safety
The study was stopped early (reason given: Difficulty of recruitment following COVID-19. Decision to stop the study of the rehabilitation center.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Background: PubMed 31372555Bruyneel AV. Effects of dance activities on patients with chronic pathologies: scoping review. Heliyon. 2019 Jul 20;5(7):e02104. doi: 10.1016/j.heliyon.2019.e02104. eCollection 2019 Jul.
- Background: PubMed 29745307Patterson KK, Wong JS, Nguyen TU, Brooks D. A dance program to improve gait and balance in individuals with chronic stroke: a feasibility study. Top Stroke Rehabil. 2018 Sep;25(6):410-416. doi: 10.1080/10749357.2018.1469714. Epub 2018 May 10.
- Background: PubMed 29862347Patterson KK, Wong JS, Prout EC, Brooks D. Dance for the rehabilitation of balance and gait in adults with neurological conditions other than Parkinson's disease: A systematic review. Heliyon. 2018 Mar 29;4(3):e00584. doi: 10.1016/j.heliyon.2018.e00584. eCollection 2018 Mar.
- Background: PubMed 25785497Demers M, McKinley P. Feasibility of delivering a dance intervention for subacute stroke in a rehabilitation hospital setting. Int J Environ Res Public Health. 2015 Mar 16;12(3):3120-32. doi: 10.3390/ijerph120303120.
- Derived from this study: PubMed 32998921Morice E, Moncharmont J, Jenny C, Bruyneel AV. Dancing to improve balance control, cognitive-motor functions and quality of life after stroke: a study protocol for a randomised controlled trial. BMJ Open. 2020 Sep 30;10(9):e037039. doi: 10.1136/bmjopen-2020-037039.
- Individual participant dataSharing planned: Yes. De-identified individual participant data for all primary and secondary outcome measure will be made available.
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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.
Anne-Violette Bruyneel principal investigator
Haute Ecole de Santé de Genève (SchoolHSG)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dance and Standard rehabilitation in people with Stroke, run by Anne-Violette Bruynnel at 1 site in Switzerland.
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 5 inclusion and 3 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 31 Mar 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 Switzerland. 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: Difficulty of recruitment following COVID-19. Decision to stop the study of the rehabilitation center.). 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?
Change from Baseline cognitive-motor functions in both groups (dance vs. control): cognitive recovery (time frame: 6 weeks). 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?
On the ClinicalTrials.gov record for NCT04120467, which also lists 5 linked publications.
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 31 Mar 2022.