A Novel Ballet-inspired Low-impact At-home Workout Programme for Adults With Stroke
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|ClinicalTrials.gov Identifier: NCT04460794|
Recruitment Status : Recruiting
First Posted : July 8, 2020
Last Update Posted : March 15, 2022
|Condition or disease||Intervention/treatment||Phase|
|Stroke Gait, Unsteady Balance; Distorted Memory Impairment||Behavioral: Ballet-inspired workouts Other: Usual care||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|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|
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
- 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 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 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 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 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.
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
|Contact: Suzanne Lo||852 firstname.lastname@example.org|
|Alice Ho Miu Ling Nethersole Hospital||Recruiting|
|Hong Kong, Hong Kong|
|Contact: Suzanne Lo 85239434485 email@example.com|
|Principal Investigator:||Suzanne Lo||Chinese University of Hong Kong|