Dance for the Improvement of Balance and Gait After Stroke (DASRCT)

August 23, 2019 updated by: Kara Patterson, University Health Network, Toronto

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

136

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2A2
        • Recruiting
        • Toronto Rehabilitation Institute
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. > 6 months post stroke
  2. Ability to transfer sit to stand and stand to sit with minimal use of arm rests
  3. Ability to stand without physical support from an aid or another person for 30 seconds
  4. Ability to walk 10m without physical assistance from a walking device, but with standby assistance from another person if needed
  5. Ability to follow 2-3 step instructions with minimal prompting from another person
  6. Have received clearance from their physician to participate in exercise.

Exclusion Criteria:

  1. Severe hearing loss
  2. Pre-existing conditions that significantly impact gait and balance (e.g. osteoarthritis)
  3. Other neurological conditions that impact gait and balance (e.g. PD).
  4. Have participated in a dance class within the past 12 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dance intervention
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.
Other: Dance
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.
Other Names:
  • Intervention group
Active Comparator: Exercise and mindfulness meditation
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.
Other: Mindfulness meditation and Exercise
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.
Other Names:
  • Control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
at study completion on average 14 weeks
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
at study completion on average 14 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in social isolation
Time Frame: at study completion on average 14 weeks

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)
at study completion on average 14 weeks
Change in Quality of life scale
Time Frame: at study completion on average 14 weeks

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).
at study completion on average 14 weeks
Change in balance confidence
Time Frame: at study completion on average 14 weeks

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
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
active range of motion of the shoulder assessed using a measuring tape and a ruler to quantify arm elevation, lateral rotation and medial rotation.
at study completion on average 14 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Collaborators

Heart and Stroke Foundation of Canada

Investigators

  • Principal Investigator: Kara Patterson, PhD, Toronto Rehabilitation/ University of Toronto
  • Principal Investigator: Dina Brooks, PhD, Toronto Rehabilitation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2019

Primary Completion (Anticipated)

December 31, 2021

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

August 7, 2019

First Submitted That Met QC Criteria

August 23, 2019

First Posted (Actual)

August 28, 2019

Study Record Updates

Last Update Posted (Actual)

August 28, 2019

Last Update Submitted That Met QC Criteria

August 23, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • G-17-0018263

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Individual participant data will not be made available.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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