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Trial registered on ANZCTR


Registration number
ACTRN12618000394246
Ethics application status
Approved
Date submitted
6/03/2018
Date registered
16/03/2018
Date last updated
16/03/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The effects of a home-based tongue strength training program in adults with swallowing disorders
Scientific title
The effects of a home-based lingual strength training program using the Iowa Oral Performance Instrument (IOPI) in adults with dysphagia
Secondary ID [1] 294253 0
None
Universal Trial Number (UTN)
U1111-1210-3822
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dysphagia 306934 0
Condition category
Condition code
Physical Medicine / Rehabilitation 306034 306034 0 0
Speech therapy
Oral and Gastrointestinal 306140 306140 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention: IOPI (Iowa Oral Performance Instrument), a biofeedback device that measures tongue pressure produced in kiloPascals (kPa) using an air-filled bulb.

The training protocol consists of a 6-week regime with the participant doing exercises in their home setting. Each participant will be trained individually by the investigators and different exercises will be instructed. After instruction, the participant will be allowed to take the IOPI home for the length of the study to do the exercises at home.

Participants will also be required to complete exercises independently on two other days each week, which will take 10-15 minutes and will be asked to record these practice sessions in a provided diary.

One of the researchers will contact each participant weekly via Skype to evaluate how the exercises are going and if needed, to adjust some of the exercises. Each of these sessions will span 30 minutes to 1 hour and will take place at a time that is suitable for the participant. Only for the first and last session (which will take about 60 minutes), the participant needs to attend the University of Sydney campus.

Dr Bogaardt is a qualified speech pathologist who is a specialist in the use of biofeedback intervention for patients with dysphagia. All investigators will be required to review the Instructions for Use (IFU) of the IOPI device, and it will be used according to its intended use. Dr Bogaardt will supervise the first 5 sessions using the device to ensure the device is being used correctly according to the IFU.

Intervention code [1] 300549 0
Rehabilitation
Intervention code [2] 300627 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 305064 0
The maximum isometric lingual pressure generated anteriorly as measured in kPa using the IOPI.
Timepoint [1] 305064 0
After 6 weeks of intervention
Primary outcome [2] 305156 0
The maximum isometric lingual pressure generated posteriorly as measured in kPa using the IOPI.
Timepoint [2] 305156 0
After 6 weeks of intervention
Secondary outcome [1] 344048 0
Patient self-reported Quality of Life-related to dysphagia will be measured using SWAL-QoL.
Timepoint [1] 344048 0
After 6 weeks of intervention
Secondary outcome [2] 344351 0
Cost-utility of the intervention will be derived using the EQ-3D
Timepoint [2] 344351 0
After 6 weeks of intervention

Eligibility
Key inclusion criteria
•Patients with self-reported swallowing problems;
•Aged 18 years or older;
•Mini Mental State Examination (MMSE) score higher than 21;
•Willing to participate and is willing to provide informed consent to participate in the study and has a weekly schedule that will allow for training to occur;
• Access to technology that will enable telehealth to operate i.e. computer/laptop with a webcam.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
•A history of seizures;
•Pain disorder of the face or jaw, for example, temporomandibular joint disorder;
•Has visual difficulties that would prevent reading from a screen and see feedback lights on the IOPI.

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
As this is a study for investigating the effects of a home-based IOPI program for people with dysphagia, there is a lack of precedent literature to give an indication of appropriate sample size. Julious (2005) recommends that a minimum of 12 participants is required for pilot studies in order to ensure feasibility and precision of the mean and variance. As this study will include a heterogeneous group of patients with dysphagia based on different etiologies (with four main groups: stroke, PD, MS and other underlying causes), we suggest to include a minimum of 60 patients in this study (15 per group), to allow a 20% drop-out rate.

Data will be presented with the range, mean and median, including standard deviations and variances.
Ordinal data collected will be analysed using the Wilcoxon-Mann Whitney test or the Kruskal-Wallis test, dependent on the number of levels. Categorical data collected will be analysed using the Chi-square test or the Fisher’s exact test. Data correlations will be calculated using Pearson’s correlation coefficient (r). Alternatively, Spearman’s rho (p) will be used if the analysis is non-parametric. Correlation coefficients of less than 0.3 will be considered weak, coefficients between 0.3-0.7 will be considered substantial, and values over 0.7 will be regarded as strong correlations.


Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
19/03/2018
Actual
Date of last participant enrolment
Anticipated
15/11/2019
Actual
Date of last data collection
Anticipated
31/12/2019
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 298891 0
University
Name [1] 298891 0
The University of Sydney / Fac. Health Sciences
Country [1] 298891 0
Australia
Primary sponsor type
University
Name
The University of Sydney / Fac. Health Sciences
Address
75 East Street
Lidcombe NSW 2141
Country
Australia
Secondary sponsor category [1] 298105 0
None
Name [1] 298105 0
Address [1] 298105 0
Country [1] 298105 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299835 0
Human Research Ethics Committee The University of Sydney
Ethics committee address [1] 299835 0
Ethics committee country [1] 299835 0
Australia
Date submitted for ethics approval [1] 299835 0
22/12/2017
Approval date [1] 299835 0
22/02/2018
Ethics approval number [1] 299835 0
2017/726

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

Contacts
Principal investigator
Name 81710 0
Dr Hans Bogaardt
Address 81710 0
The University of Sydney
Faculty of Health Sciences / T425
75 East Street
Lidcombe NSW 2141
Country 81710 0
Australia
Phone 81710 0
+61 2 9351 9334
Fax 81710 0
Email 81710 0
hans.bogaardt@sydney.edu.au
Contact person for public queries
Name 81711 0
Hans Bogaardt
Address 81711 0
The University of Sydney
Faculty of Health Sciences / T425
75 East Street
Lidcombe NSW 2141
Country 81711 0
Australia
Phone 81711 0
+61 2 9351 9334
Fax 81711 0
Email 81711 0
hans.bogaardt@sydney.edu.au
Contact person for scientific queries
Name 81712 0
Hans Bogaardt
Address 81712 0
The University of Sydney
Faculty of Health Sciences / T425
75 East Street
Lidcombe NSW 2141
Country 81712 0
Australia
Phone 81712 0
+61 2 9351 9334
Fax 81712 0
Email 81712 0
hans.bogaardt@sydney.edu.au

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.