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

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

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

Study Overview

• Status: Completed
• Conditions: Stroke; Memory Impairment; Gait, Unsteady; Balance; Distorted
• Intervention / Treatment: Behavioral: Ballet-inspired workouts; Other: Usual care

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Suzanne Lo; Phone Number: 852 39434485; Email: suzannelo@cuhk.edu.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Alice Ho Miu Ling Nethersole Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ballet-inspired workout programme (Group A); 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; 8 weeks, delivered by volunteers with a self-directed resource package
Other: Usual care (Group B); 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; Usual care and general recommendations on basic stretching and leg exercises for stroke survivors

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Investigators: Principal Investigator: Suzanne Lo, Chinese University of Hong Kong

Publications and helpful links

General Publications

• Lo SHS, Chau JPC, Choi KC, Yeung J, Li SH, Demers M. Feasibility of a ballet-inspired low-impact at-home workout programme for adults with stroke: a mixed-methods exploratory study protocol. BMJ Open. 2021 Apr 13;11(4):e045064. doi: 10.1136/bmjopen-2020-045064.

Study record dates

Study Major Dates

• Study Start (Actual): August 3, 2020
• Primary Completion (Actual): October 30, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: July 3, 2020
• First Submitted That Met QC Criteria: July 6, 2020
• First Posted (Actual): July 8, 2020

Study Record Updates

• Last Update Posted (Estimated): February 9, 2024
• Last Update Submitted That Met QC Criteria: February 8, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Stroke; Gait Disorders, Neurologic
• Other Study ID Numbers: FBB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The datasets used and/or analysed during the current study will be available from the corresponding author on reasonable request.
• IPD Sharing Time Frame: The datasets used and/or analysed during the current study will be available from the corresponding author on reasonable request, for six years upon completion of the study.
• IPD Sharing Access Criteria: The datasets used and/or analysed during the current study will be available from the corresponding author on reasonable request.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No