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临床试验/NCT04460794
NCT04460794已完成不适用

Feasibility of a Novel Ballet-inspired Low-impact At-home Workout Programme to Improve Balance, Gait and Memory in Adults with Stroke: a Mixed Methods Exploratory Trial

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2020年8月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
32
试验地点
1
主要终点
Change in the participants' level of balance

研究概览

简要总结

To explore the feasibility of a novel ballet-inspired low-impact at-home workout programme for community-dwelling stroke survivors in Hong Kong.

详细描述

A mixed methods exploratory study incorporating a randomised controlled trial (RCT) and qualitative evaluation will be conducted. A total of 40 stroke participants will be recruited from two acute public hospitals. Participants will be randomly assigned to receive the interention and usual care, or usual care only. Data will be collected in multiple forms: recruitment/retention rates, adherence to the intervention, journals, field notes, verbal feedback, audio records, semi-structured interviews, and questionnaires on outcomes (balance, confidence in balance, gait, walking endurance). This study is the first of its kind in Hong Kong. Findings will address the cross-cultural applicability of dance interventions and lay the groundwork for examination in a larger-RCT about its effects on survivors' balance, gait and memory.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • aged 18 years or above
  • clinically diagnosed with a first-ever ischaemic/ haemorrhagic stroke
  • living in home settings
  • mild-moderate lower limb paresis with a modified Functional Ambulation Classification (MFAC) of III (Dependent walker) or above
  • a Montreal Cognitive Assessment (MoCA) score>20
  • able to follow three-step directions
  • able to communicate in Cantonese and read Traditional Chinese
  • their hearing and/or visual disturbances corrected by hearing aids and/or glasses
  • consent to participate in the study

排除标准

  • diagnosed with transcient ischaemic attack, subdural or epidural haemorrhage
  • experienced cerebrovascular events due to tumours or head trauma
  • have pre-existing neurological, cardiovascular or orthopaedic conditions that contradict participation in dancing such as shoulder dislocation, myocardial infarction, seizures or acutes illness
  • mental condition such as depression, schizophrenia or personality disorder
  • incomprehensible speech
  • severe hearing and/or visual disturbance

结局指标

主要结局

Change in the participants' level of balance

时间窗: Change from baseline to immediately after completion of the intervention (over 8 weeks)

The 14-item Mini-Balance Evaluation Systems Test (Mini-BESTest) will be used. It measures four domains: anticipatory postural adjustments, reactive postural control, sensory orientation, dynamic gait. Items are rated on a 3-level scale (0="Severe", 1="Moderate", 2="Normal"). Summed total score=0-28 (higher scores representing better balance ability). Cronbach alpha=0.89-0.94.

次要结局

  • Change in the participants' level of balance confidence(Change from baseline to immediately after completion of the intervention (over 8 weeks))
  • Change in the participants' level of gait(Change from baseline to immediately after completion of the intervention (over 8 weeks))
  • Change in participants' level of memory(Change from baseline to immediately after completion of the intervention (over 8 weeks))
  • Change in participants' level of walking endurance(Change from baseline to immediately after completion of the intervention (over 8 weeks))

研究者

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

Suzanne HS Lo

Assistant Professor

Chinese University of Hong Kong

研究点 (1)

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