NCT04069481

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
136

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 7, 2019

Completed
21 days until next milestone

First Posted

Study publicly available on registry

August 28, 2019

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

August 28, 2019

Status Verified

August 1, 2019

Enrollment Period

3 years

First QC Date

August 7, 2019

Last Update Submit

August 23, 2019

Conditions

Keywords

DanceStrokeRandomized Controlled TrialRehabilitationGaitBalance

Outcome Measures

Primary Outcomes (2)

  • 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.

    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

    at study completion on average 14 weeks

Secondary Outcomes (4)

  • Change in social isolation

    at study completion on average 14 weeks

  • Change in Quality of life scale

    at study completion on average 14 weeks

  • Change in balance confidence

    at study completion on average 14 weeks

  • Change in upper extremity active range of motion (AROM)

    at study completion on average 14 weeks

Study Arms (2)

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.

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.

Other: Mindfulness meditation and Exercise

Interventions

DanceOTHER

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.

Also known as: Intervention group
Dance intervention

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.

Also known as: Control group
Exercise and mindfulness meditation

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • \> 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Toronto Rehabilitation Institute

Toronto, Ontario, M5G 2A2, Canada

RECRUITING

Related Publications (11)

  • 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.

    PMID: 23559522BACKGROUND
  • Wong 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.

    PMID: 24630463BACKGROUND
  • Patterson 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.

    PMID: 20841442BACKGROUND
  • Garland 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.

    PMID: 14669179BACKGROUND
  • Hawthorne G Measuring social isolation in older adults: development and initial validation of the friendship scale. Social Indicators Research 2006; 77: 521-548

    BACKGROUND
  • 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.

    PMID: 10390308BACKGROUND
  • Powell 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.

    PMID: 7814786BACKGROUND
  • Botner 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.

    PMID: 15824045BACKGROUND
  • Uswatte 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.

    PMID: 16224078BACKGROUND
  • Borg GA. Psychophysical bases of perceived exertion. Med Sci Sports Exerc. 1982;14(5):377-81.

    PMID: 7154893BACKGROUND
  • Patterson 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.

    PMID: 29745307BACKGROUND

MeSH Terms

Conditions

Stroke

Interventions

MindfulnessExerciseControl Groups

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaEpidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Kara Patterson, PhD

    Toronto Rehabilitation/ University of Toronto

    PRINCIPAL INVESTIGATOR
  • Dina Brooks, PhD

    Toronto Rehabilitation

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wade Michaelchuk, MSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Two groups of participants. One group receives the dance intervention. The control group will receive mindful meditation, strengthening \& stretching exercises.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Scientist

Study Record Dates

First Submitted

August 7, 2019

First Posted

August 28, 2019

Study Start

January 1, 2019

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

August 28, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be made available.

Locations