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Trial registered on ANZCTR


Registration number
ACTRN12624001252505p
Ethics application status
Not yet submitted
Date submitted
16/08/2024
Date registered
14/10/2024
Date last updated
14/10/2024
Date data sharing statement initially provided
14/10/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Swallowing Therapy in People with Parkinson’s Disease using Principles of Motor Learning and Ultrasound Biofeedback
Scientific title
Effect of Swallowing Therapy on efficiency of eating and drinking in People with Parkinson’s Disease using Principles of Motor Learning and Ultrasound Biofeedback
Secondary ID [1] 312535 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Swallowing Difficulties 334692 0
Parkinson’s Disease 334693 0
Condition category
Condition code
Neurological 331258 331258 0 0
Parkinson's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention Name: Swallow Therapy with Ultrasound Biofeedback

In this approach, an ultrasound probe will be placed under the participant’s chin and a real time video image of the tongue within the mouth will be seen while the participant is eating or drinking. This approach is referred to as ultrasound biofeedback. The intervention will consist of swallowing liquids or food with ultrasound biofeedback on the tongue movement pattern while swallowing.

This is an individual intervention and will be delivered three times a week across four weeks. Each intervention session will take approximately 45-60 minutes and involve up to 50 swallows (either fluid, food, or saliva swallows). The intervention will be conducted face to face by a speech pathologist with more than five years of experience in managing swallowing difficulties. The intervention will take place at either the University of Sydney SPEECH Clinic or the participant’s home within metropolitan Sydney at a mutually convenient time. No home practice is required.

The intervention will be individually titrated in terms of (a) frequency and duration of the treatment sessions, (b) the duration and frequency of breaks provided (c) the type of foods and fluids used, (d) the amount and type of feedback provided and (e) the number of times the participant is asked to swallow. These components will be altered based on participants’ fatigue level and response to the intervention protocol. Participant’s fatigue level will be monitored during each intervention session while the participant’s response to the therapy protocol will be reviewed on the 1st intervention session each week.

To maintain treatment fidelity, intervention will be conducted as per a pre-written intervention protocol. Treatment fidelity will be reviewed by an independent speech pathologist for a random 20% selection of intervention sessions during the study using a checklist to ensure adherence to the intended protocol.
Intervention code [1] 329217 0
Rehabilitation
Intervention code [2] 329453 0
Treatment: Devices
Intervention code [3] 329454 0
Behaviour
Comparator / control treatment
The comparator within this study are the speech outcomes that are not expected to change. The participants will continue with their usual care throughout the study. Usual care is whatever the participant is doing regardless of their participation in this study.
Control group
Active

Outcomes
Primary outcome [1] 339081 0
Speed of drinking
Timepoint [1] 339081 0
This outcome will be assessed at initial assessment, three times weekly during baseline period (either 2 or 3 weeks), twice weekly during intervention period (4 weeks), three times weekly during maintenance period (either 2 or 3 weeks) and once during follow-up (4 weeks post intervention)
Primary outcome [2] 339082 0
Speed of eating
Timepoint [2] 339082 0
This outcome will be assessed at initial assessment, three times weekly during baseline period (either 2 or 3 weeks), twice weekly during intervention period (4 weeks), three times weekly during maintenance period (either 2 or 3 weeks) and once during follow-up (4 weeks post intervention).
Secondary outcome [1] 438490 0
Texture of food
Timepoint [1] 438490 0
This outcome will be assessed at initial assessment, three times weekly during baseline period (either 2 or 3 weeks), twice weekly during intervention period (4 weeks), three times weekly during maintenance period (either 2 or 3 weeks) and once during follow-up (4 weeks post intervention).
Secondary outcome [2] 438491 0
Changes in the efficiency of tongue movement during swallowing
Timepoint [2] 438491 0
This outcome will be assessed at initial assessment, three times weekly during baseline period (either 2 or 3 weeks), twice weekly during intervention period (4 weeks), three times weekly during maintenance period (either 2 or 3 weeks) and once during follow-up (4 weeks post intervention)
Secondary outcome [3] 438492 0
Quality of Life related to swallowing
Timepoint [3] 438492 0
Initial assessment (2-3 weeks before intervention), Immediately post intervention, and 4 weeks post intervention.
Secondary outcome [4] 438493 0
Time taken to eat a meal
Timepoint [4] 438493 0
This outcome will be assessed once at initial assessment, three times weekly during baseline period (either 2 or 3 weeks), twice weekly during intervention period (4 weeks), three times weekly during maintenance period (either 2 or 3 weeks) and once during follow-up (4 weeks post intervention)
Secondary outcome [5] 438494 0
Feasibility of the intervention
Timepoint [5] 438494 0
Once immediately post intervention period
Secondary outcome [6] 439492 0
Consistency of liquid
Timepoint [6] 439492 0
This outcome will be assessed at initial assessment, three times weekly during baseline period (either 2 or 3 weeks), twice weekly during intervention period (4 weeks), three times weekly during maintenance period (either 2 or 3 weeks) and once during follow-up (4 weeks post intervention).

Eligibility
Key inclusion criteria
Participants with:
1. Confirmed diagnosis of Idiopathic Parkinson’s Disease by a neurologist
2. Self-reported changes in swallow function in the last 12 months
3. Ability to assent to participation in study (either verbal or written)
4. Presence of oral phase dysphagia as assessed by a speech pathologist.
5. Medically stable
6. Living in the community
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants with:
1. Other concomitant neurological disorders
2. A history of head and neck cancer
3. Unmanaged hearing or vision difficulties
4. Nil by Mouth status.
5. Unable to communicate in English
6. Hospitalised with a respiratory tract infection in the last 12 weeks.

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
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
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
1/11/2024
Actual
Date of last participant enrolment
Anticipated
1/07/2026
Actual
Date of last data collection
Anticipated
30/09/2026
Actual
Sample size
Target
6
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 316959 0
Self funded/Unfunded
Name [1] 316959 0
Unfunded
Country [1] 316959 0
Primary sponsor type
University
Name
The University of Sydney
Address
Country
Australia
Secondary sponsor category [1] 319206 0
None
Name [1] 319206 0
Address [1] 319206 0
Country [1] 319206 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 315714 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 315714 0
Ethics committee country [1] 315714 0
Australia
Date submitted for ethics approval [1] 315714 0
14/10/2024
Approval date [1] 315714 0
Ethics approval number [1] 315714 0

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

Contacts
Principal investigator
Name 135578 0
Prof Patricia McCabe
Address 135578 0
Susan Wakil Health Building, D18 Western Avenue, The University of Sydney, Camperdown, NSW 2006
Country 135578 0
Australia
Phone 135578 0
+61 2 9351 9539
Fax 135578 0
Email 135578 0
tricia.mccabe@sydney.edu.au
Contact person for public queries
Name 135579 0
Dharshini Manoharan
Address 135579 0
Susan Wakil Health Building, D18 Western Avenue, The University of Sydney, Camperdown, NSW 2006
Country 135579 0
Australia
Phone 135579 0
+61 2 9351 9539
Fax 135579 0
Email 135579 0
dharshini.m@sydney.edu.au
Contact person for scientific queries
Name 135580 0
Dharshini Manoharan
Address 135580 0
Susan Wakil Health Building, D18 Western Avenue, The University of Sydney, Camperdown, NSW 2006
Country 135580 0
Australia
Phone 135580 0
+61 2 9351 9539
Fax 135580 0
Email 135580 0
dharshini.m@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified demographic information and outcome measures will be archived and shared on Open Science Framework.
When will data be available (start and end dates)?
Data will be available immediately following publication. There is no end date determined.
Available to whom?
Anyone who wishes to access it may do so on Open Science Framework
Available for what types of analyses?
Any purpose
How or where can data be obtained?
This data will be shared via the open online platform through https://osf.io
Dharshini Manoharan can be contacted through email (dharshini.m@sydney.edu.au) regarding IPD until the data repository is available.


What supporting documents are/will be available?




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.