Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12607000306415
Ethics application status
Approved
Date submitted
1/06/2007
Date registered
12/06/2007
Date last updated
12/10/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
How do people with a spinal cord injury sing?
Scientific title
An investigation into the mechanisms used when singing by 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 1849 0
Condition category
Condition code
Injuries and Accidents 1943 1943 0 0
Studies of the normal brain and nervous system

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Observational study comparing respiratory function and voice projection between quadriplegics and able-bodied, matched controls when singing and speaking. Physiological assessments of respiratory function and acoustic and perceptual assessments of voice projection (approx 1 hour each in duration) will constitute outcome measures for the study.
Intervention code [1] 1800 0
None
Comparator / control treatment
There is no treatment as such, just an assessment which is the same for both the quadriplegic subjects and the able-bodied matched controls
Control group
Active

Outcomes
Primary outcome [1] 2760 0
Respiratory capacity - Ventilatory function and upper airway function will be assessed using maximal flow-volume loops to determine maximal inspiratory and expiratory flow rates, and timed lung volumes. Static lung volumes will be measured using whole-body plethysmography in those subjects able to sit in the plethysmograph, or by inert-gas dilution otherwise.
Timepoint [1] 2760 0
Measured when the participant enters the study and undergoes all the physiological and voice assessments. This single measurement (comprising both the physiological and voice assessments) is the basis for comparison between subjects.
Primary outcome [2] 2761 0
Respiratory muscle strength (specifically maximal sniff and inspiratory (MIP) muscle pressures) - Respiratory muscle strength will be assessed by measuring maximal inspiratory (MIP), expiratory (MEP) and sniff (SNIP) pressures. Patterns of tidal respiration will be assessed using calibrated respiratory-inductive plethysmography (Respitrace) to document relative contributions to ventilation of thoracic and abdominal compartments. Surface measurements of muscle (EMG) activity will be made to examine the relative timing and magnitude of the contribution from respiratory and postural muscles.
Timepoint [2] 2761 0
Measured when the participant enters the study and undergoes all the physiological and voice assessments. This single measurement (comprising both the physiological and voice assessments) is the basis for comparison between subjects.
Primary outcome [3] 2762 0
Quantitative measures of voice (pitch, amplitude) - Spectrum analysis of vocal data will be conducted by extracting acoustic parameters (e.g., pitch, amplitude, and spectral characteristics) produced during speech/voice production using calibrated recording equipment and speech analysis software. These analyses will provide quantitative measures of voice quality.
Timepoint [3] 2762 0
Measured when the participant enters the study and undergoes all the physiological and voice assessments. This single measurement (comprising both the physiological and voice assessments) is the basis for comparison between subjects.
Secondary outcome [1] 4653 0
Measures of thoraco-abdominal motion, indices of respiratory flow and volume and qualitative assessments of voice. Patterns of tidal respiration will be assessed using calibrated respiratory-inductive plethysmography (Respitrace) to document relative contributions to ventilation of thoracic and abdominal compartments. Surface measurements of muscle (EMG) activity will be made to examine the relative timing and magnitude of the contribution from respiratory and postural muscles. A standardized perceptual voice assessment (Frenchay Dysarthria Assessment) will be conducted by an experienced speech pathologist. The assessment period for when these outcomes will be measured is when the participant enters the study and undergoes all the physiological and voice assessments. This single measurement (comprising both the physiological and voice assessments) is the basis for comparison between subjects.
Timepoint [1] 4653 0
Measured when the participant enters the study and undergoes all the physiological and voice assessments. This single measurement (comprising both the physiological and voice assessments) is the basis for comparison between subjects

Eligibility
Key inclusion criteria
Quadriplegia C4-C6, at least 1 year post injury. Currently resident in Victoria and able to travel to assessment sessions. 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. Tracheostomy. Currently receiving singing or voice tuition.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Case control
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/11/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 2085 0
Government body
Name [1] 2085 0
Victorian Neurotrauma Incentive
Country [1] 2085 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] 1891 0
Other
Name [1] 1891 0
Institute for Breathing and Sleep
Address [1] 1891 0
Bowen Centre, Austin Hospital, PO Box 5555, Studley Rd, Heidelberg, Victoria 3084, Australia
Country [1] 1891 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3876 0
Austin Health,
Ethics committee address [1] 3876 0
Ethics committee country [1] 3876 0
Australia
Date submitted for ethics approval [1] 3876 0
25/05/2007
Approval date [1] 3876 0
21/12/2007
Ethics approval number [1] 3876 0
H2007/02932

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

Contacts
Principal investigator
Name 27903 0
Address 27903 0
Country 27903 0
Phone 27903 0
Fax 27903 0
Email 27903 0
Contact person for public queries
Name 10989 0
Jeanette Tamplin
Address 10989 0
Institute for Breathing and Sleep, Bowen Centre, Austin Hospital, PO Box 5555 Studley Rd, Heidelberg, 3084, Victoria, Australia
Country 10989 0
Australia
Phone 10989 0
+61 3 94963877
Fax 10989 0
+61 3 94907329
Email 10989 0
[email protected]
Contact person for scientific queries
Name 1917 0
Jeanette Tamplin
Address 1917 0
Institute for Breathing and Sleep, Bowen Centre, Austin Hospital, PO Box 5555 Studley Rd, Heidelberg, 3084, Victoria, Australia
Country 1917 0
Australia
Phone 1917 0
+61 3 94963877 or 0402019753
Fax 1917 0
+61 3 94907329
Email 1917 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.