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临床试验/NCT04069481
NCT04069481Unknown不适用

Dance for the Improvement of Balance and Gait After Stroke: A Randomized Controlled Trial

University Health Network, Toronto1 个研究点 分布在 1 个国家目标入组 136 人开始时间: 2019年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
136
试验地点
1
主要终点
Change in gait speed

研究概览

简要总结

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.

详细描述

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.

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

性别
All
接受健康志愿者
否

入选标准

  • •> 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.

排除标准

  • •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

研究组 & 干预措施

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.

干预措施: Dance (Other)

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.

干预措施: Mindfulness meditation and Exercise (Other)

结局指标

主要结局

Change in gait speed

时间窗: at study completion on average 14 weeks

Gait speed will be measured in m/sec with a with a pressure sensitive mat

Change in balance

时间窗: 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.

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kara Patterson

Scientist

University Health Network, Toronto

研究点 (1)

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