Chronic StrokeDASRCTNCT04069481
Dance for the Improvement of Balance and Gait After Stroke
A study testing Dance and Mindfulness meditation and Exercise in people with Chronic Stroke, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
Stroke can drastically impact the ability to walk and keep your balance. In addition people with chronic stroke feel social isolated, become less satisfied with their walking and lose confidence in their ability to move without falling. Ned new treatments are needed for walking and balance. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Stroke
- What is being tested?
- Dance and Mindfulness meditation and Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jan 2019to 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- > 6 months post stroke
- Ability to transfer sit to stand and stand to sit with minimal use of arm rests
- Ability to stand without physical support from an aid or another person for 30 seconds
- Ability to walk 10m without physical assistance from a walking device, but with standby assistance from another person if needed
- Ability to follow 2-3 step instructions with minimal prompting from another person
- Have received clearance from their physician to participate in exercise.
Who cannot join
- Severe hearing loss
- Pre-existing conditions that significantly impact gait and balance (e.g. osteoarthritis)
- Other neurological conditions that impact gait and balance (e.g. PD).
- Have participated in a dance class within the past 12 months
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Toronto Rehabilitation Institute
Toronto, Ontario, M5G 2A2
Wade Michaelchuk, MSc, 416-597-3422 ext. 7827, wade.michaelchuk@uhn.ca
About this study
Official title: Dance for the Improvement of Balance and Gait After Stroke: A Randomized Controlled Trial
Stroke can drastically impact the ability to walk and keep your balance. In addition people with chronic stroke feel social isolated, become less satisfied with their walking and lose confidence in their ability to move without falling.
Ned new treatments are needed for walking and balance. Dancing is a fun, social activity that has similar benefits to traditional exercise. Another benefit of dancing is the use of music, which improves mood, increases motivation and can even improve motor performance. Finally, moving in synchrony with other people during dancing can make people feel connected. We believe that dance classes can benefit people with stroke, but few studies have been done.
The objective of our project is to conduct a randomized controlled trial to test whether dance can improve balance and walking for people with chronic stroke. The investigators are also interested in whether dancing improves people's confidence in their ability to do activities without losing their balance (i.e. balance confidence), decreases their feelings of isolation and increases their quality of life.
Read the detailed description
This study is a randomized controlled trial to investigate the effects of an adapted dance program for people with chronic stroke. Participants with stroke living in the community will be randomly assigned to either the dance group or the control group. Participants will attend classes 2 times a week for 12 weeks. The primary outcomes are change in balance balance (measured with the Mini BESTest) and change in gait speed. Participants will be assessed before and after the 12 week program.
- Conditions
- Chronic Stroke
- Being tested
- Dance, Mindfulness meditation and Exercise
- Keywords
- Dance, Stroke, Randomized Controlled Trial, Rehabilitation, Gait, Balance
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DanceOther
Also called Intervention group
One-hour class, twice a week. Classes include dance warm up exercises, various dance movements and choreography that include coordinated whole body movements through space synchronized to music.
Mindfulness meditation and ExerciseOther
Also called Control group
One hour class, twice a week. Classes include upper and lower extremity stretching and resistance exercises and mindfulness meditation, that includes body scan technique and breathing exercises.
| Study group | Role | What they receive |
|---|---|---|
| Dance intervention | Experimental | Participants will receive a 1-hour group dance class twice a week for 12 weeks. Classes will include a seated warm up, dance exercises in standing, dance activities moving across the floor, throughout the space and conclude with a bow exercise. Music and dance styles will vary and personal preference of participants will also be taken into account. Receives: Other: Dance |
| Exercise and mindfulness meditation | Active comparator | Participants will receive a 1-hour group exercise class twice a week for 12 weeks. Classes will include resistance training exercises with resistance bands, stretching and range of motion exercises in seated and standing positions. Classes will also include mindfulness exercises. During active exercises music will be played and personal preference of participant will be taken into account. Receives: Other: Mindfulness meditation and Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in balance
Mini-Balance Evaluation Systems Test (Mini-BESTest)
The Mini-BESTest is a 14-item performance-based clinical scale that will be used to measure balance during standing and walking activities. There are 4 subscales in the miniBESTest and the scores on the subscales are summed to create the total score. The miniBESTest total score can range form 0-56 and higher scores indicate better balance. The Mini-BESTest shows good inter- (ICC 0.96) and intra-rater (ICC=0.97) and test-retest reliability (ICC=0.98) in the stroke population.
Measured: at study completion on average 14 weeks
Change in gait speed
Gait speed will be measured in m/sec with a with a pressure sensitive mat
Measured: at study completion on average 14 weeks
Secondary outcomes (4)
Change in social isolation
Friendship scale
The Friendship scale is a short (6-item) and user-friendly measure of perceived social isolation developed for older adults. It has a maximum score of 24 and lower scores indicate higher levels of social isolation. It has internal structure (RMSEA=0.02) and reliability (Chronbach α=0.83)
Measured: at study completion on average 14 weeks
Change in Quality of life scale
Stroke Specific Quality Of Life scale (SS-QOL)
The SS-QOL is a self-report scale containing 49 items in 12 domains ranging from mobility and energy to mood and language. The SS-QOL has both domain scores and an overall SS-QOL summary score. The domain scores are unweighted averages of the associated items while the summary score is an unweighted average of all twelve domain scores. The scores can range from 0 to 5 and higher scores indicate better quality of life.
The SS-QOL had good internal consistency (range Chronbach α=0.75-0.89), test-retest reliability (r=0.92) and inter-rater reliability (r=0.92).
Measured: at study completion on average 14 weeks
Change in balance confidence
Activity Balance Confidence Scale (ABC)
The ABC is a 16-item self-report scale that requires individuals indicate their confidence in performing various activities without losing their balance or becoming unsteady. The ABC total score is calculated as an average of the ratings for the 16 items. The score ranges from 0-100 and higher scores indicate greater confidence. The ABC scale has good internal consistency (α=0.94) and test-retest reliability (ICC =0.85) in individuals with chronic stroke living in the community
Measured: at study completion on average 14 weeks
Change in upper extremity active range of motion (AROM)
active range of motion of the shoulder assessed using a measuring tape and a ruler to quantify arm elevation, lateral rotation and medial rotation.
Measured: at study completion on average 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start1 Jan 2019
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Chronic StrokeStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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
- Model description
- Two groups of participants. One group receives the dance intervention. The control group will receive mindful meditation, strengthening \& stretching exercises.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Heart and Stroke Foundation of Canada
- Responsible party
- Principal investigator, Kara Patterson, University Health Network, Toronto
- Investigators
- Kara Patterson, PhD, Principal investigator, Toronto Rehabilitation/ University of TorontoDina Brooks, PhD, Principal investigator, Toronto Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04069481
- Sponsor's protocol ID
- G-17-0018263
- Acronym
- DASRCT
- Status last verified
- Aug 2019
- First submitted
- 7 Aug 2019
- Last updated
- 28 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be made available.
Publications
Tsang CS, Liao LR, Chung RC, Pang MY. Psychometric properties of the Mini-Balance Evaluation Systems Test (Mini-BESTest) in community-dwelling individuals with chronic stroke. Phys Ther. 2013 Aug;93(8):1102-15. doi: 10.2522/ptj.20120454. Epub 2013 Apr 4.
PubMed 23559522Wong JS, Jasani H, Poon V, Inness EL, McIlroy WE, Mansfield A. Inter- and intra-rater reliability of the GAITRite system among individuals with sub-acute stroke. Gait Posture. 2014;40(1):259-61. doi: 10.1016/j.gaitpost.2014.02.007. Epub 2014 Feb 26.
PubMed 24630463Patterson KK, Gage WH, Brooks D, Black SE, McIlroy WE. Changes in gait symmetry and velocity after stroke: a cross-sectional study from weeks to years after stroke. Neurorehabil Neural Repair. 2010 Nov-Dec;24(9):783-90. doi: 10.1177/1545968310372091. Epub 2010 Sep 14.
PubMed 20841442Garland SJ, Willems DA, Ivanova TD, Miller KJ. Recovery of standing balance and functional mobility after stroke. Arch Phys Med Rehabil. 2003 Dec;84(12):1753-9. doi: 10.1016/j.apmr.2003.03.002.
PubMed 14669179Hawthorne G Measuring social isolation in older adults: development and initial validation of the friendship scale. Social Indicators Research 2006; 77: 521-548
Williams LS, Weinberger M, Harris LE, Clark DO, Biller J. Development of a stroke-specific quality of life scale. Stroke. 1999 Jul;30(7):1362-9. doi: 10.1161/01.str.30.7.1362.
PubMed 10390308Powell LE, Myers AM. The Activities-specific Balance Confidence (ABC) Scale. J Gerontol A Biol Sci Med Sci. 1995 Jan;50A(1):M28-34. doi: 10.1093/gerona/50a.1.m28.
PubMed 7814786Botner EM, Miller WC, Eng JJ. Measurement properties of the Activities-specific Balance Confidence Scale among individuals with stroke. Disabil Rehabil. 2005 Feb 18;27(4):156-63. doi: 10.1080/09638280400008982.
PubMed 15824045Uswatte G, Taub E, Morris D, Vignolo M, McCulloch K. Reliability and validity of the upper-extremity Motor Activity Log-14 for measuring real-world arm use. Stroke. 2005 Nov;36(11):2493-6. doi: 10.1161/01.STR.0000185928.90848.2e. Epub 2005 Oct 13.
PubMed 16224078Borg GA. Psychophysical bases of perceived exertion. Med Sci Sports Exerc. 1982;14(5):377-81.
PubMed 7154893Patterson 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 29745307
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dance for the Improvement of Balance and Gait After Stroke: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04069481
- Acronym / sponsor ID
- DASRCT / G-17-0018263
- Conditions
- Chronic Stroke
- Keywords
- Dance, Stroke, Randomized Controlled Trial, Rehabilitation, Gait, Balance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Heart and Stroke Foundation of Canada
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 28 Aug 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.
Stroke can drastically impact the ability to walk and keep your balance. In addition people with chronic stroke feel social isolated, become less satisfied with their walking and lose confidence in their ability to move without falling.
Ned new treatments are needed for walking and balance. Dancing is a fun, social activity that has similar benefits to traditional exercise. Another benefit of dancing is the use of music, which improves mood, increases motivation and can even improve motor performance. Finally, moving in synchrony with other people during dancing can make people feel connected. We believe that dance classes can benefit people with stroke, but few studies have been done.
The objective of our project is to conduct a randomized controlled trial to test whether dance can improve balance and walking for people with chronic stroke. The investigators are also interested in whether dancing improves people's confidence in their ability to do activities without losing their balance (i.e. balance confidence), decreases their feelings of isolation and increases their quality of life.
Detailed description
This study is a randomized controlled trial to investigate the effects of an adapted dance program for people with chronic stroke. Participants with stroke living in the community will be randomly assigned to either the dance group or the control group. Participants will attend classes 2 times a week for 12 weeks. The primary outcomes are change in balance balance (measured with the Mini BESTest) and change in gait speed. Participants will be assessed before and after the 12 week program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Two groups of participants. One group receives the dance intervention. The control group will receive mindful meditation, strengthening \& stretching exercises.
| Arm | Type | Receives |
|---|---|---|
| Dance intervention | Experimental | Other: DanceParticipants will receive a 1-hour group dance class twice a week for 12 weeks. Classes will include a seated warm up, dance exercises in standing, dance activities moving across the floor, throughout the space and conclude with a bow exercise. Music and dance styles will vary and personal preference of participants will also be taken into account. |
| Exercise and mindfulness meditation | Active comparator | Other: Mindfulness meditation and ExerciseParticipants will receive a 1-hour group exercise class twice a week for 12 weeks. Classes will include resistance training exercises with resistance bands, stretching and range of motion exercises in seated and standing positions. Classes will also include mindfulness exercises. During active exercises music will be played and personal preference of participant will be taken into account. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- > 6 months post stroke
- Ability to transfer sit to stand and stand to sit with minimal use of arm rests
- Ability to stand without physical support from an aid or another person for 30 seconds
- Ability to walk 10m without physical assistance from a walking device, but with standby assistance from another person if needed
- Ability to follow 2-3 step instructions with minimal prompting from another person
Key exclusion criteria (4 listed)
- Severe hearing loss
- Pre-existing conditions that significantly impact gait and balance (e.g. osteoarthritis)
- Other neurological conditions that impact gait and balance (e.g. PD).
- Have participated in a dance class within the past 12 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 |
|---|---|---|
| DanceAlso: Intervention groupOne-hour class, twice a week. Classes include dance warm up exercises, various dance movements and choreography that include coordinated whole body movements through space synchronized to music. | Other | Dance intervention |
| Mindfulness meditation and ExerciseAlso: Control groupOne hour class, twice a week. Classes include upper and lower extremity stretching and resistance exercises and mindfulness meditation, that includes body scan technique and breathing exercises. | Other | Exercise and mindfulness meditation |
Primary outcome
Change in balance
Time frame: at study completion on average 14 weeks
Mini-Balance Evaluation Systems Test (Mini-BESTest) The Mini-BESTest is a 14-item performance-based clinical scale that will be used to measure balance during standing and walking activities. There are 4 subscales in the miniBESTest and the scores on the subscales are summed to create the total score. The miniBESTest total score can range form 0-56 and higher scores indicate better balance. The Mini-BESTest shows good inter- (ICC 0.96) and intra-rater (ICC=0.97) and test-retest reliability (ICC=0.98) in the stroke population.
Change in gait speed
Time frame: at study completion on average 14 weeks
Gait speed will be measured in m/sec with a with a pressure sensitive mat
4 secondary outcomes
Change in social isolation
Time frame: at study completion on average 14 weeks
Change in Quality of life scale
Time frame: at study completion on average 14 weeks
Change in balance confidence
Time frame: at study completion on average 14 weeks
Change in upper extremity active range of motion (AROM)
Time frame: at study completion on average 14 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
- Background: PubMed 23559522Tsang CS, Liao LR, Chung RC, Pang MY. Psychometric properties of the Mini-Balance Evaluation Systems Test (Mini-BESTest) in community-dwelling individuals with chronic stroke. Phys Ther. 2013 Aug;93(8):1102-15. doi: 10.2522/ptj.20120454. Epub 2013 Apr 4.
- Background: PubMed 24630463Wong JS, Jasani H, Poon V, Inness EL, McIlroy WE, Mansfield A. Inter- and intra-rater reliability of the GAITRite system among individuals with sub-acute stroke. Gait Posture. 2014;40(1):259-61. doi: 10.1016/j.gaitpost.2014.02.007. Epub 2014 Feb 26.
- Background: PubMed 20841442Patterson KK, Gage WH, Brooks D, Black SE, McIlroy WE. Changes in gait symmetry and velocity after stroke: a cross-sectional study from weeks to years after stroke. Neurorehabil Neural Repair. 2010 Nov-Dec;24(9):783-90. doi: 10.1177/1545968310372091. Epub 2010 Sep 14.
- Background: PubMed 14669179Garland SJ, Willems DA, Ivanova TD, Miller KJ. Recovery of standing balance and functional mobility after stroke. Arch Phys Med Rehabil. 2003 Dec;84(12):1753-9. doi: 10.1016/j.apmr.2003.03.002.
- BackgroundHawthorne G Measuring social isolation in older adults: development and initial validation of the friendship scale. Social Indicators Research 2006; 77: 521-548
- Background: PubMed 10390308Williams LS, Weinberger M, Harris LE, Clark DO, Biller J. Development of a stroke-specific quality of life scale. Stroke. 1999 Jul;30(7):1362-9. doi: 10.1161/01.str.30.7.1362.
- Background: PubMed 7814786Powell LE, Myers AM. The Activities-specific Balance Confidence (ABC) Scale. J Gerontol A Biol Sci Med Sci. 1995 Jan;50A(1):M28-34. doi: 10.1093/gerona/50a.1.m28.
- Background: PubMed 15824045Botner EM, Miller WC, Eng JJ. Measurement properties of the Activities-specific Balance Confidence Scale among individuals with stroke. Disabil Rehabil. 2005 Feb 18;27(4):156-63. doi: 10.1080/09638280400008982.
- Background: PubMed 16224078Uswatte G, Taub E, Morris D, Vignolo M, McCulloch K. Reliability and validity of the upper-extremity Motor Activity Log-14 for measuring real-world arm use. Stroke. 2005 Nov;36(11):2493-6. doi: 10.1161/01.STR.0000185928.90848.2e. Epub 2005 Oct 13.
- Background: PubMed 7154893Borg GA. Psychophysical bases of perceived exertion. Med Sci Sports Exerc. 1982;14(5):377-81.
- 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.
- Individual participant dataSharing planned: No. Individual participant data will not 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.
Kara Patterson, PhD principal investigator
Toronto Rehabilitation/ University of Toronto
Dina Brooks, PhD principal investigator
Toronto Rehabilitation
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 Mindfulness meditation and Exercise in people with Chronic Stroke, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 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: status not confirmed, as of the sponsor's last update on 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wade Michaelchuk, MSc (416-597-3422 ext. 7827, wade.michaelchuk@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in balance (time frame: at study completion on average 14 weeks). 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 NCT04069481, which also lists 11 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 28 Aug 2019.