- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04460794
A Novel Ballet-inspired Low-impact At-home Workout Programme for Adults With Stroke
February 8, 2024 updated by: Suzanne HS Lo, Chinese University of Hong Kong
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
Intervention / Treatment
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
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Suzanne Lo
- Phone Number: 852 39434485
- Email: suzannelo@cuhk.edu.hk
Study Locations
-
-
-
Hong Kong, Hong Kong
- Alice Ho Miu Ling Nethersole Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
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.
|
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.
|
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
Time Frame: 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.
|
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
Time Frame: 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.
|
Change from baseline to immediately after completion of the intervention (over 8 weeks)
|
Change in the participants' level of gait
Time Frame: 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.
|
Change from baseline to immediately after completion of the intervention (over 8 weeks)
|
Change in participants' level of walking endurance
Time Frame: 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).
|
Change from baseline to immediately after completion of the intervention (over 8 weeks)
|
Change in participants' level of memory
Time Frame: 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.
|
Change from baseline to immediately after completion of the intervention (over 8 weeks)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Suzanne Lo, Chinese University of Hong Kong
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Stroke
-
University Hospital, GhentRecruitingStroke | Stroke, Ischemic | Stroke, Acute | Stroke Sequelae | Stroke HemorrhagicBelgium
-
Moleac Pte Ltd.RecruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke, Cardiovascular | Strokes Thrombotic | Stroke, Embolic | Stroke, CryptogenicSingapore, Philippines
-
Moleac Pte Ltd.Not yet recruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke, Cardiovascular | Strokes Thrombotic | Stroke, Embolic | Stroke, Cryptogenic
-
IRCCS San Camillo, Venezia, ItalyRecruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke HemorrhagicItaly
-
Vanderbilt University Medical CenterPatient-Centered Outcomes Research Institute; University of Alabama at BirminghamEnrolling by invitationStroke | Stroke, Ischemic | Stroke, Acute | Stroke Sequelae | Engagement, Patient | Stroke HemorrhagicUnited States
-
University of MinnesotaAmerican Occupational Therapy FoundationRecruitingStroke | Stroke Sequelae | Stroke Hemorrhagic | Stroke IschemicUnited States
-
University of British ColumbiaCanadian Institutes of Health Research (CIHR); Michael Smith Foundation for...RecruitingStroke | Stroke, Ischemic | Stroke Hemorrhagic | Chronic StrokeCanada
-
University of CincinnatiMedical University of South Carolina; University of California, Los Angeles; University...RecruitingStroke | Stroke, Ischemic | Stroke, Acute | Stroke HemorrhagicUnited States
-
University of LiegeCompletedStroke, Acute | Stroke Hemorrhagic | Stroke, ComplicationBelgium
-
Turkish Stroke Research and Clinical Trials NetworkElectroCore INC; Turkish Neurological SocietyCompletedStroke | Stroke, Ischemic | Stroke, Acute | Stroke, HemorrhagicTurkey
Clinical Trials on Ballet-inspired workouts
-
Universidade Federal de Santa MariaSuspended
-
Skidmore CollegeCompleted
-
Citlali Lopez-OrtizCompleted
-
University of Illinois at Urbana-ChampaignUnknownMultiple Sclerosis, Relapsing-RemittingUnited States
-
Kaohsiung Medical University Chung-Ho Memorial...RecruitingSatisfaction | Working Memory | Balance | Lower Limb | Strength | ComplianceTaiwan
-
Federal University of Rio Grande do SulCompleted
-
Istanbul UniversityKoşuyolu Kartal Heart Training and Research HospitalUnknown
-
Rowan UniversityCompleted
-
United States Army Research Institute of Environmental...Completed
-
Beth Israel Deaconess Medical CenterCompletedChronic Obstructive Pulmonary DiseaseUnited States