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

Primary Purpose

Stroke, Gait, Unsteady, Balance; Distorted

Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Ballet-inspired workouts
Usual care
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Alice Ho Miu Ling Nethersole HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Ballet-inspired workout programme (Group A)

Usual care (Group B)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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 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 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 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.

Full Information

First Posted
July 3, 2020
Last Updated
June 5, 2023
Sponsor
Chinese University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT04460794
Brief Title
A Novel Ballet-inspired Low-impact At-home Workout Programme for Adults With Stroke
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 3, 2020 (Actual)
Primary Completion Date
April 30, 2023 (Actual)
Study Completion Date
October 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Gait, Unsteady, Balance; Distorted, Memory Impairment

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ballet-inspired workout programme (Group A)
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual care (Group B)
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Ballet-inspired workouts
Intervention Description
8 weeks, delivered by volunteers with a self-directed resource package
Intervention Type
Other
Intervention Name(s)
Usual care
Intervention Description
Usual care and general recommendations on basic stretching and leg exercises for stroke survivors
Primary Outcome Measure Information:
Title
Change in the participants' level of balance
Description
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.
Time Frame
Change from baseline to immediately after completion of the intervention (over 8 weeks)
Secondary Outcome Measure Information:
Title
Change in the participants' level of balance confidence
Description
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.
Time Frame
Change from baseline to immediately after completion of the intervention (over 8 weeks)
Title
Change in the participants' level of gait
Description
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.
Time Frame
Change from baseline to immediately after completion of the intervention (over 8 weeks)
Title
Change in participants' level of walking endurance
Description
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).
Time Frame
Change from baseline to immediately after completion of the intervention (over 8 weeks)
Title
Change in participants' level of memory
Description
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.
Time Frame
Change from baseline to immediately after completion of the intervention (over 8 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Suzanne Lo
Phone
852 39434485
Email
suzannelo@cuhk.edu.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suzanne Lo
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alice Ho Miu Ling Nethersole Hospital
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suzanne Lo
Phone
85239434485
Email
suzannelo@cuhk.edu.hk

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
33849853
Citation
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.
Results Reference
derived

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

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