跳至主要内容
临床试验/NCT04120467
NCT04120467终止不适用

Dance After a Stroke to Restore Pleasure in Physical Activity to Improve Cognitive and Motor Functions, Quality of Life and Well-being

Anne-Violette Bruynnel2 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2020年2月3日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
16
试验地点
2
主要终点
Change from baseline cognitive-motor functions in both groups (dance vs. control): functional ability recovery

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
45 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

Change from baseline cognitive-motor functions in both groups (dance vs. control): functional ability recovery

时间窗: 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.

Change from baseline cognitive-motor functions in both groups (dance vs. control): balance recovery

时间窗: 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): lower limbs muscle strength recovery

时间窗: 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): balance confidence recovery

时间窗: 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): cognitive recovery

时间窗: 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): standing balance recovery

时间窗: 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): coordination recovery

时间窗: 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.

次要结局

  • 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)
  • Change from baseline Quality of life in both groups (dance vs. control)(6 weeks)

研究者

发起方
Anne-Violette Bruynnel
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Anne-Violette Bruynnel

Professor (assistant)

School of Health Sciences Geneva

研究点 (2)

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