Improving Participation in Stroke Survivors With Hemiparesis by Movement Improvisation Skill Building and Care Transition-friendly Adaptive Dance Activities: A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Change in the level of participation in daily and social activities
研究概览
简要总结
The project will investigate the effects of a novel 12-week Movement Improvisation Skill-building and Adaptive Dance Intervention (MDI) on participation, balance, mobility, balance confidence, psychological well-being, and health-related quality of life in survivors with hemiparesis.
详细描述
A 2-arm, assessor-blinded, randomised controlled trial will be conducted. Individuals who are 18-80 years old and have hemiparesis after a first-ever/recurrent ischaemic/haemorrhagic stroke will be recruited. The participants will be randomly allocated to the control group receiving usual care or the intervention group receiving MDI and usual care. Based on Bandura's principles of Self-efficacy and Outcome Expectation, MDI is an online/hybrid intervention aimed to assist survivors in developing body awareness, body sense, movement improvisational skills, and abilities in creating mental images of movements and balance during their transition of care from the acute settings to home. The outcomes will be assessed before the intervention, immediately post-intervention, and 3 and 6 months post-intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •a first-ever/recurrent ischaemic/haemorrhagic stroke confirmed by imaging tests,
- •receiving in-patient care at an acute stroke unit,
- •a National Institutes of Health Stroke Scale (NIHSS) total score of <16 (mild to moderate stroke),
- •hemiparesis after stroke with the affected limb(s) scoring 1-3 on the NIHSS motor arm and/or motor leg items, respectively (drift to no effort against gravity),
- •a modified Rankin Scale (mRS) score of 2-4 (slight to moderately severe disability), and
- •a Montreal Cognitive Assessment (MoCA) score of >2nd percentile.
排除标准
- •transient ischaemic attack,
- •subdural or epidural haemorrhage,
- •cerebrovascular event due to brain tumour or a head injury,
- •neurologic, orthopaedic, muscular, rheumatic or vestibular condition that can interfere with participation in the intervention such as seizure or spinal injury,
- •mental condition such as depression or schizophrenia, or
- •visual or auditory impairment that cannot be corrected by visual/hearing aids.
研究组 & 干预措施
Movement Improvisation Skill-building and Adaptive Dance Intervention
The MDI is a hybrid in-person/online intervention aimed at developing body awareness, body sense, movement improvisational skills, and the ability to create mental images of movements and balance among stroke survivors with hemiparesis.
干预措施: Movement Improvisation Skill-building and Adaptive Dance Intervention (Other)
Usual care
Usual care
结局指标
主要结局
Change in the level of participation in daily and social activities
时间窗: From baseline to immediately, 3 months and 6 months post-intervention
The Reintegration to Normal Living Index (Chinese version) will be used to assess participants' participation in daily and social activities.
次要结局
- Change in the level of balancing ability(From baseline to immediately, 3 months and 6 months post-intervention)
- Change in the level of mobility(From baseline to immediately, 3 months and 6 months post-intervention)
- Change in the level of balance confidence(From baseline to immediately, 3 months and 6 months post-intervention)
- Change in the level of psychological well-being(From baseline to immediately, 3 months and 6 months post-intervention)
- Change in the level of health-related quality of life(From baseline to immediately, 3 months and 6 months post-intervention)
研究者
Suzanne HS Lo
Associate Professor
Chinese University of Hong Kong