Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000157976p
Ethics application status
Submitted, not yet approved
Date submitted
16/01/2020
Date registered
13/02/2020
Date last updated
14/03/2023
Date data sharing statement initially provided
13/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Exploring the outcomes of a ‘Loud and Proud’ maintenance group following treatment for speech difficulties associated with Parkinson’s disease
Scientific title
Exploring the outcomes of a ‘Loud and Proud’ maintenance group following treatment for hypokinetic dysarthria associated with Parkinson’s disease
Secondary ID [1] 300288 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dysarthria 315869 0
Dysphonia 315870 0
Parkinson's disease 316027 0
Condition category
Condition code
Neurological 314151 314151 0 0
Parkinson's disease
Physical Medicine / Rehabilitation 314305 314305 0 0
Speech therapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The treatment approach with the highest level of evidence that has been found to be effective for speech and voice difficulties associated with Parkinson's Disease is the Lee Silverman Voice Technique (LSVT LOUD - an intensive therapy and LSVT X- a less intensive version) (Ramig, 2001; Ramig, Countryman, O’Brien, Hoehn, & Thompson, 1996) https://www.lsvtglobal.com/LSVTLoud in which clients are encouraged to practice "speaking loudly" in a variety of different activities e.g. with background noise, in reading, in a monologue etc.. They are taught to recalibrate their perception of how loud their voice is. Significant gains in measures of loudness and articulation have been found immediately following treatment. However, when participants were tested 2 years post treatment, loudness levels were found to have reduced significantly (Ramig, 2001; Wight & Miller, 2015). There is therefore a need for maintenance therapy following loudness therapy.

One method for maintaining gains is to have a Loud and Proud group. This continues to encourage clients to "speak loudly" in a face to face group environment in activities similar to that used in LSVT LOUD and LSVT X e.g. with background noise, when reading, in a monologue, in a conversation, when calling out to a partner to get attention, when making a request to a partner etc. The effectiveness of these groups has not been explored. In the proposed study participants will attend a loud and proud group once a week for 1 hour for 8 weeks at their local hospital. The activities selected in which participants will speak loudly will be determined by the group and will target the activities the participants and their communication partners determine are challenging for them. Participants will also be given activities at home in which to practice "speaking loudly". The treatment will be delivered by a speech pathologist who has completed training in LSVT LOUD and LSVT X.
An attendance checklist will be kept and participants will also complete a homework checklist. Home practice exercises will include diaphragmatic breathing, sustained phonation, speaking functional phrases in a loud voice, reading in a loud voice and conversing in a loud voice. Participants will be encouraged to practice for 30 minutes a day, 5 days a week, whilst participating in the group.
Intervention code [1] 316559 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 322536 0
Sound pressure levels as measured on a Digitech QM 1592 Sound Level Meter or a Digitech QM-1589 Sound Level Meter during sustained phonation, reading, a 90 second monologue and during a 5 minute conversation. This is a measure of loudness.
Timepoint [1] 322536 0
Double baseline prior to treatment during a 2 week period immediately prior to therapy and then one week immediately following treatment.
Secondary outcome [1] 378876 0
Duration of sustained phonation (saying ah) as measured by a stop watch.
Timepoint [1] 378876 0
Double baseline prior to treatment during a 2 week period immediately prior to therapy and one week immediately following treatment.
Secondary outcome [2] 378877 0
The Frenchay Dysarthria Assessment -2.
Timepoint [2] 378877 0
Completed one week prior to commencing therapy, and one week immediately following treatment.
Secondary outcome [3] 378878 0
The Communication Effectiveness Scale (Donovan et al., 2008)
Timepoint [3] 378878 0
This will be completed once prior to treatment, once one week after treatment finishes and once one month after treatment finishes.
Secondary outcome [4] 378880 0
The Parkinson's Disease Questionnaire (PDQ-39) (Jenkinson et al., 1997)
Timepoint [4] 378880 0
Double baseline prior to treatment during a 2 week period immediately prior to therapy, one week immediately following treatment and then one month following treatment.
Secondary outcome [5] 378881 0
A post therapy interview will be conducted with both the participant and their communication partner to explore whether changes have occurred to communication outside the clinic e.g. in the home and the impact these changes have had on participation.
Timepoint [5] 378881 0
A post therapy interview will also be conducted with both the participant and a communication partner to explore the impact the involvement in the group has had on their communication and participation. This post-therapy interview will occur one week after treatment has concluded.
Secondary outcome [6] 419584 0
The Communication Participation Item Bank (CPIB) (Donovan et al., 2008) . This will be completed by both the person with PD and the communication partner before and after treatment.
Timepoint [6] 419584 0
The CPIB will be completed one week after therapy ends.

Eligibility
Key inclusion criteria
Inclusion criteria will comprise: (i) a diagnosis of Parkinson's Disease (PD) (ii) received and completed loudness therapy greater than 6 months previously and less than 2 years previously (iii) a stable and optimal medication regime.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria will comprise: (i) inability to understand written or spoken English, (ii) evidence of significant cognitive impairment as indicated by the participant's medical notes (iii) the presence of an additional neurological disorder other than PD.

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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/04/2023
Actual
Date of last participant enrolment
Anticipated
8/04/2025
Actual
Date of last data collection
Anticipated
27/06/2025
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 24289 0
Bentley Health Service - Bentley
Recruitment hospital [2] 24290 0
Osborne Park Hospital - Stirling
Recruitment hospital [3] 24291 0
Armadale Kelmscott Memorial Hospital - Armadale
Recruitment postcode(s) [1] 39834 0
6102 - Bentley
Recruitment postcode(s) [2] 39835 0
6021 - Stirling
Recruitment postcode(s) [3] 39836 0
6112 - Armadale

Funding & Sponsors
Funding source category [1] 304708 0
University
Name [1] 304708 0
Curtin University
Country [1] 304708 0
Australia
Funding source category [2] 304881 0
Hospital
Name [2] 304881 0
Bentley Health Service
Country [2] 304881 0
Australia
Funding source category [3] 304882 0
Hospital
Name [3] 304882 0
Armadale Health Service
Country [3] 304882 0
Australia
Primary sponsor type
Hospital
Name
Bentley Health Service
Address
31-59 Mills St, Bentley WA 6102
Country
Australia
Secondary sponsor category [1] 305025 0
University
Name [1] 305025 0
Curtin University
Address [1] 305025 0
Kent St Bentley WA 6102
Country [1] 305025 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 305135 0
Royal Perth Hospital Human Research Ethics Committee
Ethics committee address [1] 305135 0
Ethics committee country [1] 305135 0
Australia
Date submitted for ethics approval [1] 305135 0
09/03/2020
Approval date [1] 305135 0
Ethics approval number [1] 305135 0

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

Contacts
Principal investigator
Name 99362 0
Dr Naomi Cocks
Address 99362 0
School of Allied Health, Curtin University, Kent St Bentley WA 6102
Country 99362 0
Australia
Phone 99362 0
+61 8 92662466
Fax 99362 0
Email 99362 0
[email protected]
Contact person for public queries
Name 99363 0
Naomi Cocks
Address 99363 0
School of Allied Health, Curtin University, Kent St Bentley WA 6102
Country 99363 0
Australia
Phone 99363 0
+61 8 92662466
Fax 99363 0
Email 99363 0
[email protected]
Contact person for scientific queries
Name 99364 0
Naomi Cocks
Address 99364 0
School of Allied Health, Curtin University, Kent St Bentley WA 6102
Country 99364 0
Australia
Phone 99364 0
+61 8 92662466
Fax 99364 0
Email 99364 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.