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

• Sponsor: Chinese University of Hong Kong (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04460794
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 38.9
• Patients Per Site Per Month: 1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Stroke; Gait, Unsteady; Balance; Distorted; Memory Impairment	Behavioral: Ballet-inspired workouts; Other: Usual care	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Health Services Research
• Official Title: 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
• Actual Study Start Date: Aug 3, 2020
• Anticipated Primary Completion Date: Apr 30, 2023
• Anticipated Study Completion Date: Oct 31, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Change in the participants' level of balance [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.

Secondary Outcome Measures

1. Change in the participants' level of balance confidence [Change from baseline to immediately after completion of the intervention (over 8 weeks)]

   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.

2. Change in the participants' level of gait [Change from baseline to immediately after completion of the intervention (over 8 weeks)]

   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.

3. Change in participants' level of walking endurance [Change from baseline to immediately after completion of the intervention (over 8 weeks)]

   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).

4. Change in participants' level of memory [Change from baseline to immediately after completion of the intervention (over 8 weeks)]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alice Ho Miu Ling Nethersole Hospital	Hong Kong		Hong Kong

Sponsors and Collaborators

• Chinese University of Hong Kong

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Suzanne HS Lo, Assistant Professor, Chinese University of Hong Kong
• ClinicalTrials.gov Identifier: NCT04460794
• Other Study ID Numbers: FBB
• First Posted: Jul 8, 2020
• Last Update Posted: Jul 20, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Stroke; Gait Disorders, Neurologic

Study Results

No Results Posted as of Jul 20, 2022