Clinical trial NCT04460794: 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
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Gait, Unsteady
Balance; Distorted
Memory Impairment
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2020-07-08
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility 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

Primary outcomes:
measure: Change in the participants' level of balance
timeFrame: Change from baseline to immediately after completion of the intervention (over 8 weeks)
Secondary outcomes:
measure: Change in the participants' level of balance confidence
timeFrame: Change from baseline to immediately after completion of the intervention (over 8 weeks)
measure: Change in the participants' level of gait
timeFrame: Change from baseline to immediately after completion of the intervention (over 8 weeks)
measure: Change in participants' level of walking endurance
timeFrame: Change from baseline to immediately after completion of the intervention (over 8 weeks)
measure: Change in participants' level of memory
timeFrame: Change from baseline to immediately after completion of the intervention (over 8 weeks)
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Alice Ho Miu Ling Nethersole Hospital
Study officials:
affiliation: Chinese University of Hong Kong
name: Suzanne Lo
role: PRINCIPAL_INVESTIGATOR
References:
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.