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

Stroke Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04460794
• Other study ID #: FBB
• Status: Completed
• Phase: N/A
• Start date: August 3, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: February 2024
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: December 31, 2023
• Est. primary completion date: October 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Balance; Distorted
• Gait Disorders, Neurologic
• Gait, Unsteady
• Memory Impairment
• Stroke

Intervention

Behavioral:
• Ballet-inspired workouts
8 weeks, delivered by volunteers with a self-directed resource package

Other:
• Usual care
Usual care and general recommendations on basic stretching and leg exercises for stroke survivors

Locations

Country	Name	City	State
Hong Kong	Alice Ho Miu Ling Nethersole Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)