A Novel Ballet-inspired Low-impact At-home Workout Programme for Adults With Stroke

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

Detailed Description
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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.

Official Title
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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

Conditions
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Stroke, Gait, Unsteady, Balance; Distorted, Memory Impairment

Intervention / Treatment
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* Behavioral: Ballet-inspired workouts
* Other: Usual care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ballet-inspired workout programme (Group A)<br>Participants will continue their usual activities and exercises, and in addition, receive an 8-week home-based programme delivered by trained volunteers via hybrid on-site and virtual contacts, and supported by volunteer healthcare professionals. A self-directed resource package will be developed. | Behavioral: Ballet-inspired workouts<br>* 8 weeks, delivered by volunteers with a self-directed resource package<br>|
| Other: Usual care (Group B)<br>Control participants will continue their usual activities and exercises during the study period. In addition, they will be provided with an information sheet about recommendations with pictorial demonstrations on basic stretching and leg exercises for stroke survivors. | Other: Usual care<br>* Usual care and general recommendations on basic stretching and leg exercises for stroke survivors<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the participants' level of balance | 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. | Change from baseline to immediately after completion of the intervention (over 8 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the participants' level of balance confidence | The 16-item Activities-specific Balance Confidence Scale (Chinese version) will be adopted. Participants will rate their confidence in balance associated with performing 16 daily functional activities from 0% (absolutely no confidence) to 100% (fully confident). Summed total score=0-100% (higher scores denotes higher confidence). Cronbach alpha=0.97. | Change from baseline to immediately after completion of the intervention (over 8 weeks) | 
| Change in the participants' level of gait | The 31-item Gait Assessment and Intervention tool (G.A.I.T.) will be used to measure gait: upper extremity and trunk movement control; trunk and lower extremity (stance phase); trunk and lower extremity (swing phase). Each item is scored from 0 (normal) to 3, with gradients of variation from normal (Total score: 0 (normal gait) to 62 (greatest extent of gait deviations)). It has good intra-rater and interrater reliability. | Change from baseline to immediately after completion of the intervention (over 8 weeks) | 
| Change in participants' level of walking endurance | The 6-Minute Walk Test (MWT) will be performed in accordance with American Thoracic Society guidelines. The distance walked, the time stopped and reason(s) for stopping prematurely will be recorded. 6MWT, 12MWT, and self-paced gait speed were all significantly highly correlated (r>0.90). | Change from baseline to immediately after completion of the intervention (over 8 weeks) | 
| Change in participants' level of memory | The 11-item Rivermead Behavioural Memory Test - Third Version (Chinese version) will be used. For each task, scores range from 0-2 (2-points=normal; 1-point=intermediate; 0-point=error). Total score=0-254. It demonstrated a high inter-rater reliability. Correlation between performance on parallel forms=0.67-0.84. | Change from baseline to immediately after completion of the intervention (over 8 weeks) |