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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
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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
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Secondary ID [1]
312535
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Nil known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Swallowing Difficulties
334692
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Parkinson’s Disease
334693
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Condition category
Condition code
Neurological
331258
331258
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0
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Parkinson's disease
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
329217
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Rehabilitation
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Intervention code [2]
329453
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Treatment: Devices
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Intervention code [3]
329454
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Behaviour
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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.
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Control group
Active
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Outcomes
Primary outcome [1]
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Speed of drinking
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Assessment method [1]
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Timed Water Swallow Test (TWST) (Hughes & Wiles, 1996; Sarve et al., 2021)
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Timepoint [1]
339081
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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)
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Primary outcome [2]
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Speed of eating
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Assessment method [2]
339082
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Test of Masticating and Swallowing Solids (TOMASS) (Athukorala et al., 2014; Huckabee et al., 2018)
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Timepoint [2]
339082
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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).
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Secondary outcome [1]
438490
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Texture of food
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Assessment method [1]
438490
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The International Dysphagia Diet Standardisation Initiative Level (IDDSI) (Cichero et al., 2017)
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Timepoint [1]
438490
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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).
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Secondary outcome [2]
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Changes in the efficiency of tongue movement during swallowing
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Assessment method [2]
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Observation of tongue movement with an ultrasound probe under the chin based on components 2, 3, 4, and 5 of the Modified Barium Swallow Impairment Profile (MBSImp) (Martin-Harris et al., 2008) will be used. The MBPSImp is a five-point rating scale that rates key physiological aspects of swallowing in the different phases. Components 2, 3, 4, and 5 are specifically related to the oral phase of swallowing.
Component 2: Tongue Control
Component 3: Preparation of the food of liquid in mouth
Component 4: Tongue movement
Component 5: Amount of food or liquid remaining in the mouth
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Timepoint [2]
438491
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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)
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Secondary outcome [3]
438492
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Quality of Life related to swallowing
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Assessment method [3]
438492
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Swallowing Quality of Life Questionnaire (SWAL-QoL) (McHorney et al., 2002)
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Timepoint [3]
438492
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Initial assessment (2-3 weeks before intervention), Immediately post intervention, and 4 weeks post intervention.
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Secondary outcome [4]
438493
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Time taken to eat a meal
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Assessment method [4]
438493
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Asking participants to take a picture of their meal and log how long they take to complete that meal (in minutes).
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Timepoint [4]
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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)
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Secondary outcome [5]
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Feasibility of the intervention
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Assessment method [5]
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Theoretical Framework of Acceptability based questionnaire (Sekhon, Cartwright & Francis, 2022)
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Timepoint [5]
438494
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Once immediately post intervention period
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Secondary outcome [6]
439492
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Consistency of liquid
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Assessment method [6]
439492
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The International Dysphagia Diet Standardisation Initiative Level (IDDSI) (Cichero et al., 2017)
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Timepoint [6]
439492
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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).
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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
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Minimum age
50
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
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Intervention assignment
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/11/2024
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Actual
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Date of last participant enrolment
Anticipated
1/07/2026
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Actual
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Date of last data collection
Anticipated
30/09/2026
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Actual
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Sample size
Target
6
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Funding & Sponsors
Funding source category [1]
316959
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Self funded/Unfunded
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Name [1]
316959
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Unfunded
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Address [1]
316959
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Country [1]
316959
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Primary sponsor type
University
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Name
The University of Sydney
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Address
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Country
Australia
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Secondary sponsor category [1]
319206
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None
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Name [1]
319206
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Address [1]
319206
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Country [1]
319206
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Ethics approval
Ethics application status
Not yet submitted
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Ethics committee name [1]
315714
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The University of Sydney Human Research Ethics Committee
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Ethics committee address [1]
315714
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https://www.sydney.edu.au/research/research-integrity-and-ethics.html
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Ethics committee country [1]
315714
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Australia
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Date submitted for ethics approval [1]
315714
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14/10/2024
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Approval date [1]
315714
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Ethics approval number [1]
315714
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Summary
Brief summary
Dysphagia (i.e., swallowing difficulties) is common among people with Parkinson’s Disease (PwPD). Parkinson’s Disease results in movements that are smaller and slower than desired. There is limited research evidence on intervention options that improve tongue movement patterns in PwPD. This study aims to develop and test an intervention program that works on improving tongue movement patterns when eating and drinking with the use of ultrasound visual feedback and principles of motor learning. The study will use a single case experimental design to determine the effectiveness of the developed intervention in reducing the time taken to eat and drink as well as its impact on quality of life in PwPD. The hypothesis is that PwPD with dysphagia who participate in a four-week intervention using ultrasound visual feedback and principles of motor learning will show improvements in their swallowing efficiency.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Patricia McCabe
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Address
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Susan Wakil Health Building, D18 Western Avenue, The University of Sydney, Camperdown, NSW 2006
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Country
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Australia
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Phone
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+61 2 9351 9539
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
135579
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Dharshini Manoharan
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Address
135579
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Susan Wakil Health Building, D18 Western Avenue, The University of Sydney, Camperdown, NSW 2006
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Country
135579
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Australia
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Phone
135579
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+61 2 9351 9539
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Fax
135579
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Email
135579
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[email protected]
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Contact person for scientific queries
Name
135580
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Dharshini Manoharan
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Address
135580
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Susan Wakil Health Building, D18 Western Avenue, The University of Sydney, Camperdown, NSW 2006
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Country
135580
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Australia
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Phone
135580
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+61 2 9351 9539
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Fax
135580
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Email
135580
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
De-identified demographic information and outcome measures will be archived and shared on Open Science Framework.
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When will data be available (start and end dates)?
Data will be available immediately following publication. There is no end date determined.
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Available to whom?
Anyone who wishes to access it may do so on Open Science Framework
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Available for what types of analyses?
Any purpose
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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 (
[email protected]
) regarding IPD until the data repository is available.
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
24213
Study protocol
388130-(Uploaded-24-09-2024-10-26-39)-Study Protocol V1.1_Improving Swallowing Therapy in People with Parkinson’s Disease using Principles of Motor Learning and Ultrasound Biofeedback.pdf
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.
Download to PDF