Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000291482
Ethics application status
Approved
Date submitted
31/05/2007
Date registered
1/06/2007
Date last updated
24/03/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Can singing training can improve voice projection for people with a spinal cord injury?
Scientific title
The effects of singing and vocal training on respiratory function and voice projection of people with a spinal cord injury
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Quadriplegia 1833 0
Condition category
Condition code
Respiratory 1925 1925 0 0
Normal development and function of the respiratory system
Injuries and Accidents 1926 1926 0 0
Studies of the normal brain and nervous system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
12 weeks of singing training vs an active control intervention. The treatment condition involves instruction in breath control and vocal techniques for singing and the opportunity to sing familiar, popular songs in small groups (n=4). Treatment sessions will be held twice a week for the first 4 weeks for approximately 1 hour and participants will be expected to practise at least once per week at home with a practise CD. The following 8 weeks will involve only 1 group session and 2 home practise sessions.
Intervention code [1] 1798 0
Rehabilitation
Comparator / control treatment
The control condition involves 12 weeks of music therapy activities that do not include singing: music appreciation and relaxation. The sessions will be run in small groups (n=4) similar to the treatment arm. Sessions will be held twice a week for the first 4 weeks for approximately 1 hour and once a week for the following 8 weeks.
Control group
Active

Outcomes
Primary outcome [1] 2738 0
Respiratory capacity
Timepoint [1] 2738 0
Measures of effectiveness will be made at baseline, 6weeks (midway), 12 weeks and 6 months post intervention.
Primary outcome [2] 2739 0
Respiratory muscle strength (specifically maximal sniff and inspiratory (MIP) muscle pressures)
Timepoint [2] 2739 0
Measures of effectiveness will be made at baseline, 6 weeks (midway), 12 weeks and 6 months post intervention.
Primary outcome [3] 2740 0
Quantitative measures of voice (pitch, amplitude)
Timepoint [3] 2740 0
Measures of effectiveness will be made at baseline, 6 weeks (midway), 12 weeks and 6 months post intervention.
Secondary outcome [1] 4627 0
Measures of thoraco-abdominal motion, indices of respiratory flow and volume and qualitative assessments of voice.
Timepoint [1] 4627 0
Measured at baseline, 6 weeks (midway), 12 weeks and 6 months post intervention

Eligibility
Key inclusion criteria
Quadriplegia C4-C7, at least 1 year post injury. Currently resident in Victoria and able to travel to the Royal Talbot Rehabilitation Centre for 12 weeks for training. English speaking and stable general health without pulmonary disease at the time of assessment.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Previous history of speech disorder, respiratory disease, psychiatric disorder, or neurological impairment prior to SCI. Currently receiving singing or voice tuition.

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated sequence
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
All data will be analysed by a researcher blinded to the treatment allocation (blinded assesor)
Phase
Phase 1
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/11/2007
Actual
27/04/2009
Date of last participant enrolment
Anticipated
Actual
30/04/2010
Date of last data collection
Anticipated
Actual
12/07/2010
Sample size
Target
40
Accrual to date
Final
24
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 2070 0
Government body
Name [1] 2070 0
Victorian Neurotrauma Incentive
Country [1] 2070 0
Australia
Funding source category [2] 2071 0
University
Name [2] 2071 0
University of Melbourne
Country [2] 2071 0
Australia
Primary sponsor type
Hospital
Name
Austin Health
Address
PO Box 5555 Studley Rd, Heidelberg, Victoria, 3084, Australia
Country
Australia
Secondary sponsor category [1] 1875 0
Other
Name [1] 1875 0
Institute for Breathing and Sleep,
Address [1] 1875 0
PO Box 5555 Studley Rd, Heidelberg, Victoria, 3084, Australia
Country [1] 1875 0
Australia
Secondary sponsor category [2] 1876 0
University
Name [2] 1876 0
University of Melbourne
Address [2] 1876 0
Parkville, Victoria, 3052 Australia
Country [2] 1876 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3844 0
Austin Health
Ethics committee address [1] 3844 0
Ethics committee country [1] 3844 0
Australia
Date submitted for ethics approval [1] 3844 0
25/05/2007
Approval date [1] 3844 0
21/12/2007
Ethics approval number [1] 3844 0
H2007/02931

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

Contacts
Principal investigator
Name 27901 0
Dr Jeanette Tamplin
Address 27901 0
Music Therapy
University of Melbourne
234 St Kilda Road
Southbank
VIC 3006
Country 27901 0
Australia
Phone 27901 0
+61 3 8344 3003
Fax 27901 0
Email 27901 0
[email protected]
Contact person for public queries
Name 10987 0
Jeanette Tamplin
Address 10987 0
Music Therapy
University of Melbourne
234 St Kilda Road
Southbank
VIC 3006
Country 10987 0
Australia
Phone 10987 0
+61 3 8344 3003
Fax 10987 0
no fax
Email 10987 0
[email protected]
Contact person for scientific queries
Name 1915 0
Jeanette Tamplin
Address 1915 0
Music Therapy
University of Melbourne
234 St Kilda Road
Southbank
VIC 3006
Country 1915 0
Australia
Phone 1915 0
+61 3 8344 3003
Fax 1915 0
no fax
Email 1915 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.