Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613001289707
Ethics application status
Approved
Date submitted
15/11/2013
Date registered
21/11/2013
Date last updated
21/11/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Stroke Sounds: Music Listening in Stroke Rehabilitation
Scientific title
Stroke Sounds: The effect of music listening on mood and cognition in Stroke Rehabilitation
Secondary ID [1] 283589 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cognition
 290499 0
Mood (including anxiety and depression) 290500 0
Communication Function 290501 0
Quality of Life/Function 290502 0
Stroke 290574 0
Condition category
Condition code
Stroke 290893 290893 0 0
Ischaemic
Stroke 290894 290894 0 0
Haemorrhagic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All participants will receive standard medical care and stroke rehabilitation in a comprehensive stroke unit. This includes multidisciplinary allied health assessment and rehabilitation and medical and stroke rehabilitation specialist treatment and management.
Participants in the intervention group will also listen to preferred music via an MP3 player at least one hour a day for at least 6 days a week for at least 12 weeks (Equals 70 hours). To measure compliance to the intervention, they will be required to maintain a log of the dates and times they listen to music via the MP3 player.
Intervention code [1] 288276 0
Treatment: Other
Comparator / control treatment
Control Group- participants will receive standard medical care and rehabilitation.
No treatment.
Control group
Active

Outcomes
Primary outcome [1] 290909 0
Cognition:The COGNISTAT (Neurobehavioural Cognitive Status Examination) is a validated cognitive screening assessment.
Timepoint [1] 290909 0
Baseline and at 12 weeks after intervention commencement.
Primary outcome [2] 290910 0
Mood: Hospital Anxiety Depression Scale (HADS)- a validated post stroke screening measure designed to assess the presence of mood disorder.
Timepoint [2] 290910 0
Baseline, and at 12 weeks after intervention commencement.
Secondary outcome [1] 305582 0
Communication: The Western Aphasia Battery (WAB).
Timepoint [1] 305582 0
Baseline and at 12weeks after intervention.
Secondary outcome [2] 305583 0
Quality of Life: The Stroke and Aphasia Quality Of Life scale (SAQOL-39).
Timepoint [2] 305583 0
At 24 weeks after intervention commencement.
Secondary outcome [3] 305584 0
Global Function: The Modified Rankin Score (MRS) and Functional Independence Measure (FIM®). Both are widely accepted measures in stroke rehabilitation to measure functional change
Timepoint [3] 305584 0
MRS: Baseline and discharge date from hospital. Additionally at 12 weeks and 24 weeks post intervention.

FIM:Baseline and discharge date from hospital.

Eligibility
Key inclusion criteria
Inclusion Criteria:
-Admitted our comprehensive stroke unit between June 2012 and June 2014 and accepted by the stroke consultant as a stroke rehabilitation candidate.
-Diagnosed with a stroke event in the past 7 days
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria:
-Unable to gain consent from patient/caregiver
-Diagnosis of deafness, or bilateral severe/profound hearing loss
-Palliative

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)
Pilot project conducted as a cluster controlled clinical trial.
Eligible participants allocated to an intervention group or a control group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Alternates allocation of patients recruited for a maximum of 24 months with a total of 60 participants.
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
Efficacy
Statistical methods / analysis
With assistance from a statistician, it is planned group differences in baseline characteristics and the amount of therapy received will be analysed with one-way analyses of variance (ANOVA), t-tests, chi-square tests, and Kruskal-Wallis tests. Group differences in mood and global function 3 and 6 months post-stroke will be analysed by one-way ANOVAs. Recovery in the domains of mood, cognition, communication, quality of life, and global function will be analysed using a mixed-model ANOVA with a within-subjects factor of time (baseline, 3 months, 6 months), and between-subjects factors of group (music group and control group). Post hoc tests will be performed on change scores from baseline to the 3-month and baseline to 6-month stages. The level of statistical significance will be set for P less then 0.05. All statistical analyses will be performed using SPSS.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
2/06/2012
Actual
25/07/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 1747 0
Belmont Hospital - Belmont
Recruitment postcode(s) [1] 7562 0
2280 - Belmont

Funding & Sponsors
Funding source category [1] 288286 0
Hospital
Name [1] 288286 0
Allied Health Scholarship- Hunter New England Health
Country [1] 288286 0
Australia
Funding source category [2] 288287 0
Charities/Societies/Foundations
Name [2] 288287 0
National Stroke Foundation
Country [2] 288287 0
Australia
Primary sponsor type
Hospital
Name
Hunter New England Health
Address
Hunter New England Health
Locked Bag 1
Hunter Region Mail Centre
2310, NSW
Country
Australia
Secondary sponsor category [1] 287005 0
None
Name [1] 287005 0
Address [1] 287005 0
Country [1] 287005 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290181 0
Hunter New England Research Ethics and Governance Unit
Ethics committee address [1] 290181 0
Ethics committee country [1] 290181 0
Australia
Date submitted for ethics approval [1] 290181 0
23/03/2012
Approval date [1] 290181 0
18/04/2012
Ethics approval number [1] 290181 0
12/04/18/5.06

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

Contacts
Principal investigator
Name 44302 0
Mrs Luisa Hewitt
Address 44302 0
Belmont Hospital
PO Box 2365
Gateshead, NSW 2280
Country 44302 0
Australia
Phone 44302 0
+ 61 2 49232267
Fax 44302 0
Email 44302 0
[email protected]
Contact person for public queries
Name 44303 0
Luisa Hewitt
Address 44303 0
Belmont Hospital
PO Box 2365
Gateshead, NSW 2280
Country 44303 0
Australia
Phone 44303 0
+61 2 49232267
Fax 44303 0
Email 44303 0
[email protected]
Contact person for scientific queries
Name 44304 0
Luisa Hewitt
Address 44304 0
Belmont Hospital
PO Box 2365
Gateshead, NSW 2280
Country 44304 0
Australia
Phone 44304 0
+61 2 49232267
Fax 44304 0
Email 44304 0
[email protected]

No information has been provided regarding IPD availability


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.