Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000686909
Ethics application status
Approved
Date submitted
4/07/2011
Date registered
6/07/2011
Date last updated
6/07/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Treating Voice Disorders: Which Therapy Works Best?
Scientific title
A Randomized Controlled Trial Comparing the Effect of Expiratory Muscle Strength Training versus Traditional voice therapy on dysphonia in Patients with Unilateral Vocal Fold Palsy
Secondary ID [1] 259629 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Unilateral Vocal Fold Palsy causing Dysphonia 261188 0
Condition category
Condition code
Physical Medicine / Rehabilitation 259344 259344 0 0
Speech therapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Expiratory Muscle Strength Training (EMST) arm - 6 weeks
a) subjects exhales on one breath through the expiratory pressure threshold device. Device will be set at 75% of the subject's maximum expiratory pressure (MEP).
b) five repetitions of the exercise = 1 block
c) five blocks completed daily, five days per week

Traditional voice therapy/ Usual Care arm - 6 weeks
a) release of muscle tension
b) establishment of 'Twang' voice quality
c) visual and auditory biofeedback
d) negative practice
e) improved breath support via postural stability
1x weekly one-on-one sessions with a speech pathologist for up to 60 minutes per session
Intervention code [1] 258060 0
Rehabilitation
Comparator / control treatment
Patients may be required to wait for services, in which case they will be allocated to a waitlist for 6 weeks. These patients will act as the control group, as they will be reevaluated to see if spontaneous recover has occurred prior to being allocated to one of the two 'active treatment' arm (Expiratory Muscle Strength Training OR Traditional Voice Therapy/Usual Care)
Control group
Active

Outcomes
Primary outcome [1] 262151 0
Determine which therapy is more efficacious in treating dysphonia secondary to unilateral vocal fold palsy using:
1) Videostroboscopy - measuring (a) degree of cord movement; (b) mucosal wave; (c) electroglottography
2) Consensus Auditory Perception of Voice (CAPE-V)
3) Voice Handicap Index (VHI)
Timepoint [1] 262151 0
Baseline (pre treatment) and post therapy (after 6 weeks treatment)
Secondary outcome [1] 273236 0
determine whether participants who are waitlisted for therapy experience spontaneous recovery from unilateral vocal fold palsy using
1) Videostroboscopy - measuring
(a) degree of cord movement;
(b) mucosal wave;
(c) electroglottography

2) Consensus Auditory Perception of Voice (CAPE-V)
3) Voice Handicap Index (VHI)
Timepoint [1] 273236 0
Baseline and after 6 weeks on waitlist

Eligibility
Key inclusion criteria
1. dysphonia
2. willing to participate in the study and return for follow up
3. able to understand and follow instructions
4. able to tolerate nasopharyngeal endoscopic examination
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. currently undergoing radiation therapy
2. untreated hypertension
3. diagnosis of respiratory imapirment (COPD/COAD/Emphysema)

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)
patients referred to Voice Clinic who meet inclusion criteria will be invited to participate. Once consented, they will be allocated to either (a) intervention (b) waitlisted. If they are allocated to the intervention group, they will be randomized to one of the two treatment arms. If they are waitlisted, they will be reviewed in six weeks to determine if their dysphonia has resolved. If they continue to demonstrate vocal fold palsy they will move to (a) and be randomized to one of the two interventions.

Randomization will occur using a computer program 'Sealed Envelope Limited' which wil allocate patients to one of the two active treatment arms.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
permuted block randomization using computer program 'Sealed Envelope Limited'
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/07/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 258525 0
Hospital
Name [1] 258525 0
Sir Charles Gairdner Hospital
Country [1] 258525 0
Australia
Primary sponsor type
Hospital
Name
Sir Charles Gairdner Hospital
Address
Hospital Avenue
Nedlands Western Australia 6009
Country
Australia
Secondary sponsor category [1] 257661 0
None
Name [1] 257661 0
Address [1] 257661 0
Country [1] 257661 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260492 0
Sir Charles Gairdner Hospital Human Research Ethics committee
Ethics committee address [1] 260492 0
Ethics committee country [1] 260492 0
Australia
Date submitted for ethics approval [1] 260492 0
22/02/2011
Approval date [1] 260492 0
Ethics approval number [1] 260492 0
2011-024

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

Contacts
Principal investigator
Name 32233 0
Address 32233 0
Country 32233 0
Phone 32233 0
Fax 32233 0
Email 32233 0
Contact person for public queries
Name 15480 0
Dr. Claire Langdon
Address 15480 0
Sir Charles Gairdner Hospital
Hospital Avenue
Nedlands Western Australia 6009
Country 15480 0
Australia
Phone 15480 0
61 8 9346 2044
Fax 15480 0
Email 15480 0
[email protected]
Contact person for scientific queries
Name 6408 0
Dr. Claire Langdon
Address 6408 0
Sir Charles Gairdner Hospital
Hospital Avenue
Nedlands Western Australia 6009
Country 6408 0
Australia
Phone 6408 0
61 8 9346 2044
Fax 6408 0
Email 6408 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.