NCT04120467

Brief 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. 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.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Feb 2020

Typical duration for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 2, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 9, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

February 3, 2020

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 7, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 7, 2022

Completed
Last Updated

March 31, 2022

Status Verified

March 1, 2022

Enrollment Period

2.1 years

First QC Date

October 2, 2019

Last Update Submit

March 16, 2022

Conditions

Keywords

StrokeRehabilitationDance

Outcome Measures

Primary Outcomes (7)

  • 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.

    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".

    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).

    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.

    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).

    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.

    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.

    6 weeks

Secondary Outcomes (4)

  • Change from baseline Quality of life in both groups (dance vs. control)

    6 weeks

  • Change from baseline Motivation for Physical Activity practice in both groups (dance vs. control)

    4 weeks and 6 weeks

  • Incidence of dance practice on adverse effects: existence of pain and fatigue after each dance class

    up to 6 weeks (after each dance class)

  • Level of participant's satisfaction with dance class

    6 weeks

Study Arms (2)

Dance

EXPERIMENTAL

Dance Standard rehabilitation post-stroke

Other: DanceOther: Standard rehabilitation

Control

ACTIVE COMPARATOR

Standard rehabilitation post-stroke

Other: Standard rehabilitation

Interventions

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.

Dance

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.

ControlDance

Eligibility Criteria

Age45 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Post stroke
  • Subacute phase
  • Able to endure 60 minutes of physical activity
  • Medical stability
  • Able to understand the consign

You may not qualify if:

  • Medical complications
  • Hearing disorders
  • Previous pathologies associated with balance disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institution de Lavigny

Lavigny, Canton of Vaud, 1175, Switzerland

Location

Related Publications (5)

  • 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.

    PMID: 31372555BACKGROUND
  • 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
  • Patterson 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.

    PMID: 29862347BACKGROUND
  • Demers 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.

    PMID: 25785497BACKGROUND
  • Morice 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.

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Anne-Violette Bruyneel

    Haute Ecole de Santé de Genève (SchoolHSG)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor (assistant)

Study Record Dates

First Submitted

October 2, 2019

First Posted

October 9, 2019

Study Start

February 3, 2020

Primary Completion

March 7, 2022

Study Completion

March 7, 2022

Last Updated

March 31, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will share

De-identified individual participant data for all primary and secondary outcome measure will be made available.

Time Frame
Data will be available within 6 months of study completion
Access Criteria
At the end of the project the data will be deposited in the Yareta repository developed by the University of Geneva OR in an institutional repository. This choice will ensure that data is archived and shared in accordance with FAIR principles.

Locations