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NCT Number: NCT04460794

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

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

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Key information

Conditions

Stroke Balance; Distorted Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Gait Disorders, Neurologic Gait, Unsteady Memory Disorders Memory Impairment Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alice Ho Miu Ling Nethersole Hospital

Hong Kong

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ballet-inspired workouts

Behavioral

8 weeks, delivered by volunteers with a self-directed resource package

Usual Care

Other

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jul 8, 2020
Registry last updated
Nov 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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