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Trial registered on ANZCTR


Registration number
ACTRN12621000157875
Ethics application status
Approved
Date submitted
10/01/2021
Date registered
16/02/2021
Date last updated
16/02/2021
Date data sharing statement initially provided
16/02/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Use of Expiratory Muscle Strength Training (EMST) in the treatment of dysarthria associated with Parkinsons Disease.
Scientific title
Use of Expiratory Muscle Strength Training (EMST) in the treatment of dysarthria associated with Parkinsons Disease.
Secondary ID [1] 303131 0
Nil known.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parkinsons Disease 320239 0
Dysarthria 320240 0
Condition category
Condition code
Neurological 318173 318173 0 0
Parkinson's disease
Physical Medicine / Rehabilitation 318467 318467 0 0
Speech therapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will complete training with the ‘EMST 150™' (Aspire Products, LLC) device. This is a handheld respiratory training device, that targets strength of the expiratory muscles of breathing. The device requires users to exhale into the device with a high degree of effort, in order to overcome the resistance of a spring loaded way valve.
The 'EMST-150' device can be calibrated to individual users, to ensure a high degree of effort is required to achieve the exercise task. Throughout the study, the device will be set to 75% of a participants maximal performance (i.e. 75% of the level of a resistance that the participant can overcome with maximal effort). This will be recalibrated as required on a weekly basis throughout the study.
Participants will be asked to complete therapy 5 days a week for a total of 6 weeks, following a set treatment regimen. The treatment regimen will be 25x breaths into the device, with imposed breaks between each repetition (15 second rest between each breath until 5 breaths completed, followed by a one minute break, then complete this cycle until a total of 25 breaths completed). Breaks between each repetition are enforced in order to maintain optimised performance. Each daily set of practice is estimated to take approximately 20-25 mins.
The therapy program will be overseen by the primary researcher (a speech pathologist with over 10 years experience working with people with Parkinsons Disease). Following initial demonstration of the training device, the treatment will be completed by participants independently at home (or with the assistance of a home based carer, if required). Participants will asked to keep a paper based log of their home practice so the researcher can monitor adherence to this treatment regimen, and gain insight into the participants subjective experience. This includes stating how many repetitions they did of the exercise each day, at what level of resistance the device was set, the time practiced, and any comments about their experience completing the treatment.
In addition to home practice, participants will meet with the primary researcher on a weekly basis to review their progress, adjust the setting of the EMST device as needed, monitor adherence to the training schedule, and complete weekly assessment measures. These meetings will take place in an outpatient clinic, or via telehealth (based on participant preferences).
Intervention code [1] 319430 0
Rehabilitation
Intervention code [2] 319667 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 326158 0
Voice volume in decibels during speech (measured during a reading passage), as measured with a sound pressure metre.
Timepoint [1] 326158 0
Pre-assessment measure will be taken within 1 week prior to commencement of the therapy program.
Post-intervention outcome measure will be taken within 1 week following the conclusion of the therapy intervention.

Pre and post measures will be taken at the same time of day, to prevent impact of fluctuations due to variables such as fatigue or impacts of Parkinsons Disease medications.
Primary outcome [2] 326432 0
Voice quality during speech (a reading sample), as judged using the the Russel and Oates perceptual voice profile (Oates J, Russell A: Learning voice analysis using an interactive multi-media package: development and preliminary evaluation. J Voice 1998;12:500–512). This is a rating scale used to describe disordered voice features on different parameters (e.g. strain, volume, pitch), and the degree of impairment of these features (range between normal to severe). 2x speech pathologists with at least 5 years experience working with an adult neurological population will complete the ratings (compared for inter-rater reliability).

Recordings of pre- and post- recordings will be presented in random order so raters are unfamiliar with the treatment status.
Timepoint [2] 326432 0
Pre-assessment measure will be taken within 1 week prior to commencement of the therapy program.
Post-intervention outcome measure will be taken within 1 week following the conclusion of the therapy intervention.

Pre and post measures will be taken at the same time of day, to prevent impact of fluctuations due to variables such as fatigue or impacts of Parkinsons Disease medications.
Primary outcome [3] 326433 0
Speech intelligibility, as measured using the intelligibility subtest from the 'Frenchay Dysarthria assessment' (Enderby, Pamela M. 1983. Frenchay dysarthria assessment. San Diego, Calif: College-Hill Press). This tool assesses the number of spoken words and sentences accurately understood by a listener, out of context. A person unfamiliar to the participants will be asked to listen to voice sample to complete this measurement (audio recording to be taken pre and post intervention for interpretation).
Timepoint [3] 326433 0
Pre-assessment measure will be taken within 1 week prior to commencement of the therapy program.
Post-intervention outcome measure will be taken within 1 week following the conclusion of the therapy intervention.

Pre and post measures will be taken at the same time of day, to prevent impact of fluctuations due to variables such as fatigue or impacts of Parkinsons Disease medications.
Secondary outcome [1] 390278 0
Participants self perception of their voice, and the impact of their voice dysfunction on their voice. This will be assessed using the 'Voice Handicap Index-10' (Rosen, C. A., et al. (2004). "Development and validation of the voice handicap index-10." Laryngoscope 114(9): 1549-1556.). This is a 10 item self rated questionnaire.
Timepoint [1] 390278 0
This will be completed at the same time as primary measures (i.e. within 1 week prior to treatment, and within 1 week following treatment).
Secondary outcome [2] 390279 0
‘Maximum expiratory pressure’. A ‘peak flow meter’ (handheld, non-invasive device used to record maximum speed air is expelled from the lungs) will be used to measure maximum expiratory flow. To monitor for fluctuations in performance, the participant will be asked to complete the task a minimum of 5 times, or until 3 productions achieved with scores are measured within no greater than 10% difference.

As there is no apparent risk of bias in these objective measures, these outcomes will be measured by the primary researcher.
Timepoint [2] 390279 0
Measurement will be taken at the same time as the primary outcome measures (i.e. within 1 week of prior to commencing treatment, and within 1 week following ceasing treatment).

Measures will also be taken on a weekly basis, during weekly review appointments with the primary researcher.
Secondary outcome [3] 391481 0
‘Maximum phonation time’. Participants will be asked to sustain a vowel sound as loudly as they can, for the longest duration possible. Duration will be measured using a stop watch. To monitor for fluctuations in performance, the participant will be asked to complete the task a minimum of 5 times, or until 3 productions achieved with scores are measured within no greater than 10% difference.

As there is no apparent risk of bias in these objective measures, these outcomes will be measured by the primary researcher.
Timepoint [3] 391481 0
Measurement will be taken at the same time as the primary outcome measures (i.e. within 1 week of prior to commencing treatment, and within 1 week following ceasing treatment).

Measures will also be taken on a weekly basis, during weekly review appointments with the primary researcher.

Eligibility
Key inclusion criteria
-Idiopathic Parkinsons disease, as diagnosed by a neurologist.
-Presence of hypokinetic dysarthria as per perceptual speech pathology assessment, with characteristics including decreased volume and decline in speech articulation. To avoid ceiling effect, the study is only to include those with average conversational speaking volume lower than 70dB SLP (measured using a sound pressure meter, at 50cm distance), and with speech intelligibility (as measured on the ‘Frenchay Dysarthria’ assessment) under 90%.
-Adults of any age, gender, or time post onset/diagnosis of Parkinsons Disease.
-Considered by the primary researcher as cognitively able to follow the EMST treatment protocol (this may be with assistance from a carer).
-Willingness to participate in the stated treatment program, to keep records of completed treatment, and to disclose any changes to medical status or interventions within the course of the treatment period.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded if they:
-Are currently undergoing any other form of voice or speech treatment.
-Have previously undergone intervention targeting hypokinetic dysarthria.
-Have any medical interventions that may impact their voice, speech, or Parkinsons Disease symptoms (e.g. deep brain stimulation adjustment, phonosurgery, changes to their medication cycle), planned over the period of EMST treatment
-Have any contraindications as per the ‘EMST-150’ device manual, i.e. suspected pregnancy, untreated hypertension, recent stroke or high risk of stroke, cardiac abnormalities, asthma or COPD, history of collapsed lung, head/neck surgery, untreated GORD.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Analysis will be descriptive in nature, based on the pre and post outcomes of each individual, and any shared trends observed across the 2 target participants. This includes relationships between any changes in outcome measures with regard to the study hypothesis, and the functional implication of any perceived changes, with respect to the participants self-reported experience completing the therapy regimen, and any perceived benefits they perceive as a result of completing the intervention.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2021
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
2
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 18381 0
Port Kembla Hospital - Warrawong
Recruitment postcode(s) [1] 32468 0
2502 - Warrawong

Funding & Sponsors
Funding source category [1] 307537 0
Hospital
Name [1] 307537 0
Port Kembla Hospital
Country [1] 307537 0
Australia
Primary sponsor type
Government body
Name
Illawarra Shoalhaven Local Health District
Address
67-71 King Street District Executive Office Suite 2, Level 2, Warrawong NSW 2505
Country
Australia
Secondary sponsor category [1] 308220 0
University
Name [1] 308220 0
University of Wollongong
Address [1] 308220 0
Northfields Ave Wollongong, NSW 2522
Country [1] 308220 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307603 0
Joint University of Wollongong and Illawarra Shoalhaven Local Health District Health and Medical Human Research Ethics Committee
Ethics committee address [1] 307603 0
Ethics committee country [1] 307603 0
Australia
Date submitted for ethics approval [1] 307603 0
Approval date [1] 307603 0
02/12/2019
Ethics approval number [1] 307603 0

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

Contacts
Principal investigator
Name 107826 0
Ms Kate Rowntree
Address 107826 0
Port Kembla Hospital
89-91 Cowper Street
Warrawong
NSW 2502
Country 107826 0
Australia
Phone 107826 0
+61 2 4223 8201
Fax 107826 0
Email 107826 0
[email protected]
Contact person for public queries
Name 107827 0
Kate Rowntree
Address 107827 0
Port Kembla Hospital
89-91 Cowper Street
Warrawong
NSW 2502
Country 107827 0
Australia
Phone 107827 0
+61 2 4223 8201
Fax 107827 0
Email 107827 0
[email protected]
Contact person for scientific queries
Name 107828 0
Kate Rowntree
Address 107828 0
Port Kembla Hospital
89-91 Cowper Street
Warrawong
NSW 2502
Country 107828 0
Australia
Phone 107828 0
+61 2 4223 8201
Fax 107828 0
Email 107828 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant assessment data per participant, after de-identification (pre and post assessment raw data, weekly therapy data).
When will data be available (start and end dates)?
Up to 3 years following publication of assessment findings.
Available to whom?
To anyone who requests access to the data for the purpose of further contributing to the research area, or who wishes to query the data findings for clinical purposes.
Available for what types of analyses?
Any type, to achieve the stated research/clinical purpose.
How or where can data be obtained?
By directly contacting the primary researcher (phone: +61 2 4223 2801. Email: [email protected]).


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
10211Study protocol    381192-(Uploaded-09-01-2021-16-42-21)-Study-related document.doc



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.