ANZCTR - Registration

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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

Condition category

Condition code

Respiratory

Normal development and function of the respiratory system

Injuries and Accidents

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]

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]

Respiratory capacity

Timepoint [1]

Measures of effectiveness will be made at baseline, 6weeks (midway), 12 weeks and 6 months post intervention.

Primary outcome [2]

Respiratory muscle strength (specifically maximal sniff and inspiratory (MIP) muscle pressures)

Timepoint [2]

Measures of effectiveness will be made at baseline, 6 weeks (midway), 12 weeks and 6 months post intervention.

Primary outcome [3]

Quantitative measures of voice (pitch, amplitude)

Timepoint [3]

Measures of effectiveness will be made at baseline, 6 weeks (midway), 12 weeks and 6 months post intervention.

Secondary outcome [1]

Measures of thoraco-abdominal motion, indices of respiratory flow and volume and qualitative assessments of voice.

Timepoint [1]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Victorian Neurotrauma Incentive

Address [1]

Level 14, 222 Exhibition Street, Melbourne Victoria 3000, Australia

Country [1]

Australia

Funding source category [2]

University

Name [2]

University of Melbourne

Address [2]

Parkville, Victoria, 3052, Australia

Country [2]

Australia

Primary sponsor type

Hospital

Name

Austin Health

Address

PO Box 5555 Studley Rd, Heidelberg, Victoria, 3084, Australia

Country

Australia

Secondary sponsor category [1]

Other

Name [1]

Institute for Breathing and Sleep,

Address [1]

PO Box 5555 Studley Rd, Heidelberg, Victoria, 3084, Australia

Country [1]

Australia

Secondary sponsor category [2]

University

Name [2]

University of Melbourne

Address [2]

Parkville, Victoria, 3052 Australia

Country [2]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Austin Health

Ethics committee address [1]

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

25/05/2007

Approval date [1]

21/12/2007

Ethics approval number [1]

H2007/02931

Summary

Brief summary

Respiratory dysfunction is a major cause of morbidity and mortality in spinal cord injury (SCI). Therapeutic singing exercises have been demonstrated to develop muscle control, expand lung capacity and increase vocal intensity with other clinical populations. This study will be the first to systematically document the physiological effect of singing instruction on respiratory function and voice projection in a quadriplegia population. All subjects will participate in physiological and acoustic assessments whilst vocalising, singing, and speaking. Forty subjects with chronic cervical SCI will be randomised into control and experimental groups. Subjects in the treatment group will participate in twice weekly singing instruction in small groups (n=5), with an additional weekly homepractise session, for a period of 20 weeks. All subjects will repeat the initial assessments after 10 and 20 weeks. Control subjects will participate in the vocal training after 20 weeks. The relevance of this project is indicated by research that shows that respiratory disorders and subsequent diminished vocal projection are common and disabling in the quadriplegia population. Singing training has been shown to improve respiratory capacity and voice projection in other clinical populations. In a health care setting where evidence-based practise is highly valued, the examination of the effect of this innovative therapy on ventilatory function is strongly indicated.

Trial website

Trial related presentations / publications

Tamplin, J., Baker, F., Grocke, D., & Berlowitz, D. J. (2014). A thematic analysis of the experience of group music therapy for people with chronic quadriplegia. Topics in Spinal Cord Injury Rehabilitation, 20(3), 256-268. IF: 1.226.

Tamplin, J., Baker, F., Buttifant, M., & Berlowitz, D. J. (2014). The effect of singing training on voice quality and intensity for people with quadriplegia. Journal of Voice. 28(1), 128.e19–128.e26. Doi.10.1016/j.jvoice.2013.08.017.  IF: 1.55.

Tamplin, J., Baker, F., Grocke, D., Brazzale, D., Pretto, J. J., Ruehland, W. R., et al. (2013). The effect of singing on respiratory function, voice, and mood following quadriplegia: A randomized controlled trial. Archives of Physical Medicine and Rehabilitation, 94(3), 426-434.

Public notes

Contacts

Principal investigator

Name

Dr Jeanette Tamplin

Address

Music Therapy
University of Melbourne
234 St Kilda Road
Southbank
VIC 3006

Country

Australia

Phone

+61 3 8344 3003

Fax

jeanette.tamplin@unimelb.edu.au

Contact person for public queries

Name

Jeanette Tamplin

Address

Music Therapy
University of Melbourne
234 St Kilda Road
Southbank
VIC 3006

Country

Australia

Phone

+61 3 8344 3003

Fax

no fax

jeanette.tamplin@unimelb.edu.au

Contact person for scientific queries

Name

Jeanette Tamplin

Address

Music Therapy
University of Melbourne
234 St Kilda Road
Southbank
VIC 3006

Country

Australia

Phone

+61 3 8344 3003

Fax

no fax

jeanette.tamplin@unimelb.edu.au

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.

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