Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000076178p
Ethics application status
Not yet submitted
Date submitted
14/01/2019
Date registered
21/01/2019
Date last updated
21/01/2019
Date data sharing statement initially provided
21/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Singing Cords: Peer - led therapeutic group singing for people with spinal cord injury.
Scientific title
Singing Cords: Peer - led therapeutic group singing for people with spinal cord injury.
Secondary ID [1] 297064 0
Singing Cords
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Spinal Cord Injury 311070 0
Condition category
Condition code
Physical Medicine / Rehabilitation 309706 309706 0 0
Physiotherapy
Physical Medicine / Rehabilitation 309707 309707 0 0
Speech therapy
Injuries and Accidents 309749 309749 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Peer - led therapeutic group singing program delivered in 1hour sessions twice a week for 12 weeks making a total of 24 sessions of intervention. Intervention includes education, vocal exercises and breathing exercises. The intervention over the 24 sessions will be delivered by the vocal coach, physiotherapist, speech pathologist and leisure therapist. The group will be made up of up to 10 participants.
Intervention code [1] 313337 0
Rehabilitation
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 318667 0
Forced vital capacity - measured using an EasyOne spirometer following American Thoracic Society (ATS) spirometry guidelines modified for spinal cord injury whilst participant is sitting in their wheelchair.
Timepoint [1] 318667 0
Initial, completion (after 12 weeks of the program) and follow-up at 3 months post program completion
Primary outcome [2] 318668 0
Maximal sustained phonation time - measured as the maximum length of time a participant can sustain the sound "ah" with even pitch after a large inhalation whilst sitting in their wheelchair.
Timepoint [2] 318668 0
Initial, completion (after 12 weeks of the program) and follow-up at 3 months post program completion
Primary outcome [3] 318669 0
Quality of life - measured using international spinal cord injury data sets quality of life basic data set and EQ-5D-5L tool.
Timepoint [3] 318669 0
Initial, completion (after 12 weeks of the program) and follow-up at 3 months post program completion
Secondary outcome [1] 365630 0
Voice loudness measured as sound pressure level and perceptual voice profile. This will be audio-recorded using a portable digital MP3/Wave recorder (Edirol R-1, Roland) for later perceptual and acoustic analysis. A headset microphone (AKG Model C420) will be positioned at a mouth-to-microphone distance of 5 cm during recordings. Speech samples will be recorded as digital .wav files at a sampling rate of 44.1 kHz with 16-bit quantization. Standardized instructions will be provided to participants. The examiner will provide an example and training as required to ensure compliance with the task.
Timepoint [1] 365630 0
Initial, completion (after 12 weeks of the program) and follow-up at 3 months post program completion

Eligibility
Key inclusion criteria
Newly acquired or existing clients with SCI affecting the mid thoracic and cervical levels of the spine will be eligible if also able to attend twice weekly sessions at the Princess Alexandra Hospital for a 3 month period.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Excluded if have a history of a speech disorder prior to SCI, psychiatric disorder, prior stroke or brain injury. Also excluded if significant respiratory disease which impairs their ability to complete respiratory outcome measures.

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)
Nil
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
Statistical methods / analysis
Descriptive, Paired t test

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2019
Actual
Date of last participant enrolment
Anticipated
1/05/2019
Actual
Date of last data collection
Anticipated
2/12/2019
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 12880 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 25357 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 301635 0
Hospital
Name [1] 301635 0
Hopkins Centre, Division of Rehabilitation Metro South Health.
Country [1] 301635 0
Australia
Primary sponsor type
Hospital
Name
Princess Alexandra Hospital, Metro South Health
Address
Princess Alexandra Hospital, Ipswich Rd Woolloongabba 4102 QLD
Country
Australia
Secondary sponsor category [1] 301340 0
None
Name [1] 301340 0
Address [1] 301340 0
Country [1] 301340 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 302358 0
Metro South Health Human Research Ethics Committee (HREC)
Ethics committee address [1] 302358 0
Ethics committee country [1] 302358 0
Australia
Date submitted for ethics approval [1] 302358 0
05/02/2019
Approval date [1] 302358 0
Ethics approval number [1] 302358 0

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

Contacts
Principal investigator
Name 89946 0
Mrs Brooke Wadsworth
Address 89946 0
Physiotherapy, Spinal Injuries Unit
Princess Alexandra Hospital
Ipswich Rd, Woolloongabba 4102
QLD
Country 89946 0
Australia
Phone 89946 0
+61 7 3176 2089
Fax 89946 0
Email 89946 0
[email protected]
Contact person for public queries
Name 89947 0
Brooke Wadsworth
Address 89947 0
Physiotherapy, Spinal Injuries Unit
Princess Alexandra Hospital
Ipswich Rd, Woolloongabba 4102
QLD
Country 89947 0
Australia
Phone 89947 0
+61 7 3176 2089
Fax 89947 0
Email 89947 0
[email protected]
Contact person for scientific queries
Name 89948 0
Brooke Wadsworth
Address 89948 0
Physiotherapy, Spinal Injuries Unit
Princess Alexandra Hospital
Ipswich Rd, Woolloongabba 4102
QLD
Country 89948 0
Australia
Phone 89948 0
+61 7 3176 2089
Fax 89948 0
Email 89948 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
Raw data will be confidential. Only de-identified data will be shared in the form of conference presentations, funding reports and manuscripts.


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.