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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04460794
Recruitment Status : Recruiting
First Posted : July 8, 2020
Last Update Posted : March 15, 2022
Sponsor:
Information provided by (Responsible Party):
Suzanne HS Lo, Chinese University of Hong Kong

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : August 3, 2020
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : July 31, 2023

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

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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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).

  4. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04460794


Contacts
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Contact: Suzanne Lo 852 39434485 suzannelo@cuhk.edu.hk

Locations
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Hong Kong
Alice Ho Miu Ling Nethersole Hospital Recruiting
Hong Kong, Hong Kong
Contact: Suzanne Lo    85239434485    suzannelo@cuhk.edu.hk   
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
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Principal Investigator: Suzanne Lo Chinese University of Hong Kong
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Suzanne HS Lo, Assistant Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT04460794    
Other Study ID Numbers: FBB
First Posted: July 8, 2020    Key Record Dates
Last Update Posted: March 15, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The datasets used and/or analysed during the current study will be available from the corresponding author on reasonable request.
Supporting Materials: Study Protocol
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.
Access Criteria: The datasets used and/or analysed during the current study will be available from the corresponding author on reasonable request.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stroke
Gait Disorders, Neurologic
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Neurologic Manifestations