NCT04460794

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Aug 2020

Longer than P75 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 3, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 8, 2020

Completed
26 days until next milestone

Study Start

First participant enrolled

August 3, 2020

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

November 15, 2024

Status Verified

February 1, 2024

Enrollment Period

3.2 years

First QC Date

July 3, 2020

Last Update Submit

November 13, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in the participants' level of balance

    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 Outcomes (4)

  • Change in the participants' level of balance confidence

    Change from baseline to immediately after completion of the intervention (over 8 weeks)

  • Change in the participants' level of gait

    Change from baseline to immediately after completion of the intervention (over 8 weeks)

  • Change in participants' level of walking endurance

    Change from baseline to immediately after completion of the intervention (over 8 weeks)

  • Change in participants' level of memory

    Change from baseline to immediately after completion of the intervention (over 8 weeks)

Study Arms (2)

Ballet-inspired workout programme (Group A)

EXPERIMENTAL

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

Usual care (Group B)

OTHER

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

Interventions

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

Ballet-inspired workout programme (Group A)

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

Usual care (Group B)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alice Ho Miu Ling Nethersole Hospital

Hong Kong, Hong Kong, Hong Kong

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

StrokeGait Disorders, NeurologicMemory Disorders

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsNeurobehavioral Manifestations

Study Officials

  • Suzanne Lo

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 3, 2020

First Posted

July 8, 2020

Study Start

August 3, 2020

Primary Completion

October 30, 2023

Study Completion

December 31, 2023

Last Updated

November 15, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will share

The datasets used and/or analysed during the current study will be available from the corresponding author on reasonable request.

Shared Documents
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.

Locations