Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001024538
Ethics application status
Approved
Date submitted
5/08/2024
Date registered
23/08/2024
Date last updated
23/08/2024
Date data sharing statement initially provided
23/08/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
What do you think of Movement to Music as a community support after stroke?
Scientific title
A feasibility, acceptability, and sustainability study of Movement to Music: A community support after stroke
Secondary ID [1] 312683 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
stroke 334670 0
Condition category
Condition code
Stroke 331241 331241 0 0
Haemorrhagic
Stroke 331242 331242 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Movement to Music sessions will be held weekly over the course of four weeks for approximately 1 hour each session. Through the collaboration of a registered physiotherapist and registered neurologic music therapist (NMT), tailored movement interventions are developed utilising live improvised and familiar music to target fine and gross upper limb movements, gait, balance, and lower limb strength and control to help individuals who have had a stroke to meet their health and wellbeing aspirations. Different groups of movements will be targeted each week, but individual participants movements will be tailored to their abilities based on the evaluation data gathered by the physiotherapist and the musical and therapeutic input from the neurologic music therapist.

Below are some examples of exercises for each group of movement that may be performed, including progression sequences to tailor movements to individual's abilities. Music will be played live that is familiar to the group and can be tailored to the focus of the task/session. The individuals will actively participant in instrument playing to target movements suitable for their needs and abilities.

Upper limb movements: Reaching with drum sticks/shakers with variations including moving high-low, laterally, using one hand or both hands
Fine motor movements: melodic instruments using single hand or fingers/bilateral, modifying complexity movements
Gait: Stepping in time to beat including modifications and progressions such as stepping over objects, focusing on heel strike, doing on the spot with just one leg
Balance: Stepping to targets including modifications and progressions of increasing distance, sequencing, or timing
Lower limb strength: Sit to stands in beat to a familiar song, with modifications and progressions of altering height of chair

Other activities for each group of movement may also be performed during the session under the direction of the physiotherapist and neurologic music therapist, depending on groups needs and abilities.

Before commencing Movement to Music, each potential participant will undergo a 45-60 minute pre-intervention assessment with the registered physiotherapist. The pre-intervention assessment process will check inclusion/exclusion criteria and assess any risk factors. During the pre-intervention assessment, the registered physiotherapist will also be identifying impairment levels to guide individual activities for Movement to Music intervention sessions utilising the Tinetti Balance and Gait Assessment alongside a broad clinical assessment evaluating mobility, upper limb function, specific needs, and communication.

Movement to Music will be conducted with 6-8 participants in a group, over 6-8 weeks. It will include, initial pre-intervention assessment 2-3 weeks prior to the sessions, 4 weekly Movement to Music sessions with short focus groups following, and 1 focus group 1-2 weeks following the conclusion of the Movement to Music sessions.

Focus groups will be approximately 15-20 minutes in length directly following the session. The focus will be on what individuals thought of the sessions and how they see Movement to Music potentially fitting in their living well after stroke journey.
Topics include:
- What the individual liked or wished was different about the days session
- How they would describe the days session
- If they'd observed any changes since the previous session
Intervention code [1] 329208 0
Rehabilitation
Intervention code [2] 329209 0
Lifestyle
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 339016 0
Acceptability and feasibility of Movement to Music group as a community support to live well after stroke will be assessed as a composite outcome.
Timepoint [1] 339016 0
A focus group will be conducted following each of the four Movement to Music sessions as well a 1-2 weeks following the conclusion of Movement to Music sessions.
Primary outcome [2] 339017 0
Sustainability of Movement to Music as a community support after stroke
Timepoint [2] 339017 0
2-3 weeks following the conclusion of the Movement to Music sample sessions
Secondary outcome [1] 438279 0
Feasibility of therapy lead measures
Timepoint [1] 438279 0
Observations will occur during each Movement to Music session. Following each Movement to Music session, the leading physiotherapist and neurologic music therapists will have a discussion with a final discussion upon the conclusion of the 4 Movement to Music sessions.

Eligibility
Key inclusion criteria
- Less than or equal to 2 years post stroke
-Age 18-60
-Independent with toileting or able to bring a support person to assist with toileting who can stay for the duration of each session
-Has not previously participated in Music Therapy for any condition
-Not currently participating in formal rehabilitation services (e.g., physiotherapy)
-Able to provide informed consent verbally or non-verbally (e.g. writing)
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
-Clinically deemed unable to participate in a group situation safely, including medical concerns, being unable to safely follow instructions and signs of risky impulsivity
-Currently in hospital or residential care
-Unable to understand English
-Currently has an activated enduring power of attorney (EPA)

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
6-8 participants
Data will be analysed using thematic analysis based on a general inductive approach as described by Thomas (2006). This is a straightforward approach for analysing qualitative data in a context of focused study questions. It allows for identification of general themes within the raw data.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/09/2024
Actual
Date of last participant enrolment
Anticipated
18/10/2024
Actual
Date of last data collection
Anticipated
20/12/2024
Actual
Sample size
Target
6
Accrual to date
Final
Recruitment outside Australia
Country [1] 26493 0
New Zealand
State/province [1] 26493 0
Canterbury

Funding & Sponsors
Funding source category [1] 317115 0
Government body
Name [1] 317115 0
Health Research Council of New Zealand (HRC)
Country [1] 317115 0
New Zealand
Primary sponsor type
Charities/Societies/Foundations
Name
Burwood Academy Trust
Address
Country
New Zealand
Secondary sponsor category [1] 319374 0
None
Name [1] 319374 0
Address [1] 319374 0
Country [1] 319374 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315869 0
Northern B Health and Disability Ethics Committee 
Ethics committee address [1] 315869 0
Ethics committee country [1] 315869 0
New Zealand
Date submitted for ethics approval [1] 315869 0
11/06/2024
Approval date [1] 315869 0
30/07/2024
Ethics approval number [1] 315869 0
2024 EXP 19601

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

Contacts
Principal investigator
Name 136034 0
Dr Kalie Evans
Address 136034 0
Burwood Academy Trust Private Bag 4708 Christchurch 8140
Country 136034 0
New Zealand
Phone 136034 0
+64 210 919 6871
Fax 136034 0
Email 136034 0
[email protected]
Contact person for public queries
Name 136035 0
Dr Kalie Evans
Address 136035 0
Burwood Academy Trust Private Bag 4708 Christchurch 8140
Country 136035 0
New Zealand
Phone 136035 0
+64 210 919 6871
Fax 136035 0
Email 136035 0
[email protected]
Contact person for scientific queries
Name 136036 0
Dr Kalie Evans
Address 136036 0
Burwood Academy Trust Private Bag 4708 Christchurch 8140
Country 136036 0
New Zealand
Phone 136036 0
+64 210 919 6871
Fax 136036 0
Email 136036 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Confidentiality of participants in study on basis of informed consent


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.