Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000481774
Ethics application status
Approved
Date submitted
8/03/2022
Date registered
25/03/2022
Date last updated
3/06/2024
Date data sharing statement initially provided
25/03/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of a dance program in addition to the traditional physiotherapy on physical function and mobility in older people in rehabilitation with recent acquired brain injury
Scientific title
The effect of a dance program on physical function in older individuals with recent acquired brain injury: a feasibility study conducted at Flinders Medical Centre
Secondary ID [1] 306627 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Brain injury 325546 0
Rehabilitation patients 325547 0
Stroke 325597 0
Condition category
Condition code
Physical Medicine / Rehabilitation 322915 322915 0 0
Physiotherapy
Stroke 322916 322916 0 0
Haemorrhagic
Stroke 322917 322917 0 0
Ischaemic
Physical Medicine / Rehabilitation 322918 322918 0 0
Other physical medicine / rehabilitation
Neurological 322958 322958 0 0
Other neurological disorders
Injuries and Accidents 322959 322959 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A single blind randomised controlled trial will be conducted to determine if there is a difference in outcomes following an intervention using additional dance therapy plus usual care compared with additional conventional group-based physiotherapy plus usual care, and whether the effect is sustained at one month post discharge.
For the intervention, the researchers will collect patient preferences pre and post exposure to dance therapy. The participants in the treatment group will receive their usual daily rehabilitation therapies but will be offered three additional dance therapy sessions per week delivered in a group setting for a total of 10 weeks. The usual rehabilitation therapies include Balance and gait retraining, and physical exercises to maintain balance and pain management etc. The number of participants in each group is yet to finalise.

The duration of each dance session will be 30 minutes. Classes will begin with a 5-7 minute warm-up in sitting transitioning to standing followed by dance skills and activities in pairs and in a circle. Participants will be able to dance in a seated position if required (e.g., recently admitted). Participants will not be asked to aim for a pre-specified level of intensity during the intervention sessions.
The dance therapies will be co-led by freelance dancers and the physiotherapists targeting to improve balance, strength and endurance. Information on enrolment rates, attendance, participant satisfaction and adverse events will be collected to monitor adherence during the intervention.
A co-design process will be undertaken with consumers (a seperate cohort of individuals prior patients who have suffered an acquired brain injury), dancers and therapists. Consumers will be shown an initial report of concept study at Hamsptead Rehabilitation Centre that found encouraging engagement between clients and dancers with qualitative reports that both groups understood the importance of “learning to move better”. A steering committee of consumers, dancers and the health service will meet bimonthly for one hour with a total of 6 sessions. The mode of delivery of co-design meetings will be face to face or online platform (given general health recommendations during the global pandemic) and the number of consumers in the meeting still to be finalised. The co-design process will occur after delivery of the intervention and will not affect the intervention that is delivered during this study.
Information on enrolment rates, attendance, participant satisfaction and adverse events will be collected to monitor adherence during the intervention.
Intervention code [1] 323066 0
Rehabilitation
Intervention code [2] 323102 0
Treatment: Other
Comparator / control treatment
Participants in the controlled group will be allocated to the traditional therapy group supervised by the physiotherapist from Flinders Medical Centre. For example, the Physiotherapist will provide exercises such as balance and gait retraining (related to improved balance, strength and endurance).
All participants in the controlled group will receive three additional 30 mins group-based physiotherapy sessions per week in addition to their usual daily rehabilitation therapies focused on functional mobility for 10-weeks. Rehabilitation facilities and equipment will be provided by Flinders Medical Centre.
Participants will not be asked to aim for a pre-specified level of intensity during the intervention sessions.
Information on enrolment rates, attendance, participant satisfaction and adverse events will be collected to monitor adherence during the comparator treatment.
Control group
Active

Outcomes
Primary outcome [1] 330684 0
The primary outcome will be the Short Form 36 Physical Component Summary (health related quality of life).
Timepoint [1] 330684 0
Baseline, 10 weeks (immediately postintervention) and at 14 weeks (4 weeks follow up, primary endpoint).
Secondary outcome [1] 407208 0
Activities Specific Balance Confidence Scale (to measure Balance self-efficacy).
Timepoint [1] 407208 0
Baseline, 10 weeks (immediately postintervention) and at 14 weeks
Secondary outcome [2] 407356 0
The EQ5D (to measure mood and quality of life)
Timepoint [2] 407356 0
Baseline, 10 weeks (immediately postintervention)
Secondary outcome [3] 407357 0
The Short Physical Performance Battery (to measure of mobility)
Timepoint [3] 407357 0
Baseline, 10 weeks (immediately postintervention) and at 14 weeks
Secondary outcome [4] 407358 0
A satisfaction self-designed survey questionnaire will be used to rate nine statements about the dance program using a 5-point scale (where 1= strongly disagree and 5= strongly agree)
(This questionnaire includes questions about feasibility, adherence, satisfaction, patient's preferences, and acceptability).
Timepoint [4] 407358 0
The secondary time point for the questionnaire will be 10 weeks (post-intervention)
Secondary outcome [5] 407794 0
Timed Up and Go test (to measure gait speed, balance and function)
Timepoint [5] 407794 0
Baseline, 10 weeks and at 14 weeks
Secondary outcome [6] 421122 0
Stroke self-efficacy scale.
Timepoint [6] 421122 0
Baseline, 10 weeks (immediately post-intervention) and 14 weeks
Secondary outcome [7] 421123 0
Borg rate of perceived exertion
Timepoint [7] 421123 0
10 weeks (immediately post-intervention), conducted after each group session during the 10-week intervention period
Secondary outcome [8] 421124 0
Attendance. Paper based attendance will be recorded for each group session during 10 week intervention stage.
Timepoint [8] 421124 0
10 weeks (immediately post-intervention), collected for each group session during the 10-week intervention stage.
Secondary outcome [9] 421125 0
Withdrawals. A form for withdrawal of participation was provided with the participant information and consent form.
Timepoint [9] 421125 0
Baseline, 10 weeks (immediately post-intervention) and 14 weeks
Secondary outcome [10] 421126 0
Adverse events. Adverse events would be assessed by clinicians facilitating the groups who would observe any adverse events related to the intervention (+ participant self-report). No validated tools or data linkage was used.
Timepoint [10] 421126 0
Baseline, 10 weeks (immediately post-intervention) and 14 weeks
Secondary outcome [11] 421127 0
Falls.
Falls were reported by participants during the intervention period. The clinician facilitated asked each participant at the beginning of every session if they had any new falls.
Timepoint [11] 421127 0
10 weeks (immediately post-intervention), collected for each group session during the 10-week intervention stage
Secondary outcome [12] 421128 0
Preferences.
Preferences were recorded as baseline and 10-week outcomes for a feasiblity measures of participant's satisfaction. Participants were asked if they had preferences of the following:
Dance group
Conventional physiotherapy group
No preference
Timepoint [12] 421128 0
Baseline and 10 weeks (immediately post-intervention)

Eligibility
Key inclusion criteria
The inclusion criteria for the participants are:
i) Adults with an acquired brain injury.
ii) Without significant receptive and expressive dysphasia and able to follow instructions.
iii) Given medical clearance by the medical team.
iv) Be able to perform sit-to-stand with only standby assistance and have been independently ambulating with or without mobility aid before this onset of disability.
v) Have visual acuity of at least 6/18 as measured using the Snellen Chart.
A number of units including the rehabilitation programs within the Southern Adelaide Health Service – the Rehabilitation inpatient unit (FMC) and the outpatient services, Home rehabilitation and Day Rehabilitation (FMC), outpatients at the State-wide Brain Injury service (which moves to Southern Adelaide in early 2022) will be participating to this research project.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Adults with significant receptive and expressive dysphasia and not being able to follow instructions

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The allocation involved contacting holder of the allocation schedule who was "off-site" or at central administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
This is a one-year feasibility study which will gather information for a larger trial. A sample size calculation based on a recent study in stroke patients suggests we will need to recruit 40 participants to detect a clinically and statistically significant 20% difference in the Physical Component Summary score of the SF36 between the two groups (power = 80%, p=0.05, SD = 8.5) (Fu, Weatherall et al. 2020). In addition to descriptive analyses one-way analysis of variance (ANOVA) will be used to test group differences in the primary and secondary hypotheses at week 14 (4 weeks follow up). Subgroup analyses will be done comparing participants of different ages. All analyses will be on an intention to treat basis and will be undertaken by a statistician blinded to group allocation.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
4/04/2022
Actual
24/06/2022
Date of last participant enrolment
Anticipated
Actual
6/01/2023
Date of last data collection
Anticipated
Actual
30/06/2023
Sample size
Target
40
Accrual to date
Final
49
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 21915 0
Flinders Medical Centre - Bedford Park
Recruitment postcode(s) [1] 36998 0
5042 - Bedford Park

Funding & Sponsors
Funding source category [1] 310958 0
Government body
Name [1] 310958 0
Life Support Authority
Country [1] 310958 0
Australia
Primary sponsor type
University
Name
College of Medicine and Public Health, Flinders University
Address
Flinders Medical Centre Rehab building, FMC 4W209
Medical sciences road, Bedford Park, SA 5042
Country
Australia
Secondary sponsor category [1] 312302 0
None
Name [1] 312302 0
Address [1] 312302 0
Country [1] 312302 0
Other collaborator category [1] 282193 0
University
Name [1] 282193 0
College of Humanities, Arts and Social Sciences, Finders University
Address [1] 282193 0
Level 2, Rooms 211-213, Humanities Building, Bedford Park SA 5042
Country [1] 282193 0
Australia
Other collaborator category [2] 282194 0
University
Name [2] 282194 0
Division of Health Sciences , University of South Australia
Address [2] 282194 0
City East campus (C8-54)
North Terrace, SA 5000
Country [2] 282194 0
Australia
Other collaborator category [3] 282195 0
University
Name [3] 282195 0
College of Nursing and Health Sciences, Flinders University
Address [3] 282195 0
Level 1, Room N103, Sturt North Sturt Rd, Bedford Park SA 5042
Country [3] 282195 0
Australia
Other collaborator category [4] 282196 0
Hospital
Name [4] 282196 0
Flinders Medical Centre
Address [4] 282196 0
Flinders Dr, Bedford Park SA 5042
Country [4] 282196 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310517 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 310517 0
Ethics committee country [1] 310517 0
Australia
Date submitted for ethics approval [1] 310517 0
05/03/2022
Approval date [1] 310517 0
07/04/2022
Ethics approval number [1] 310517 0
2022/HRE00014

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 117926 0
Prof Maria Crotty
Address 117926 0
College of Medicine and public Health
Flinders University
Office: Flinders Medical Centre (Rehab, FMC 4W209)
GPO Box 2100, Adelaide 5001, South Australia
Country 117926 0
Australia
Phone 117926 0
+61 8 74219791
Fax 117926 0
Email 117926 0
[email protected]
Contact person for public queries
Name 117927 0
Maria Crotty
Address 117927 0
College of Medicine and public Health
Flinders University
Office: Flinders Medical Centre (Rehab, FMC 4W209)
GPO Box 2100, Adelaide 5001, South Australia
Country 117927 0
Australia
Phone 117927 0
+61 8 74219791
Fax 117927 0
Email 117927 0
[email protected]
Contact person for scientific queries
Name 117928 0
Maria Crotty
Address 117928 0
College of Medicine and public Health
Flinders University
Office: Flinders Medical Centre (Rehab, FMC 4W209)
GPO Box 2100, Adelaide 5001, South Australia
Country 117928 0
Australia
Phone 117928 0
+61 8 74219791
Fax 117928 0
Email 117928 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Only deidentified individual participant data (with a unique participant number) collected during the trial will be shared. Individual participant data of published results only data will also be shared for research purpose.
When will data be available (start and end dates)?
No end date, available for 7 years after publication
Available to whom?
IPD will be made available to researchers who provide a methodologically sound proposal at the discretion of the principal investigator
Available for what types of analyses?
For meta-analyses, the IPD will be made available
How or where can data be obtained?
Researchers may contact the Principal Investigator regarding the access of the data if required.
Email address: [email protected]


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.