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Trial registered on ANZCTR


Registration number
ACTRN12624000706572p
Ethics application status
Submitted, not yet approved
Date submitted
13/05/2024
Date registered
4/06/2024
Date last updated
4/06/2024
Date data sharing statement initially provided
4/06/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating the feasibility of home-based training to enhance swallowing skills in children with cerebral palsy
Scientific title
Feasibility of a home-based training protocol to enhance swallowing skills in children with cerebral palsy: A pilot project
Secondary ID [1] 312130 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cerebral palsy 333774 0
Dysphagia 333775 0
Condition category
Condition code
Neurological 330449 330449 0 0
Other neurological disorders
Physical Medicine / Rehabilitation 330524 330524 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In total, there will be two research visits. Each of them will last approximately one hour.
During the first research visit, after the researcher verifies the Gross Motor Function Classification System level and completes the medical history questionnaire, they will video record two trials of three swallowing performance tests (Spontaneous Swallowing Frequency, Timed Water Swallow Test, and Test of Mastication and Swallowing Solids) to establish test-retest reliability. Additionally, after completion of swallowing performance tests, the researcher will obtain data on the clinical scales: the Functional Oral Intake Scale, the Pediatric Eating Assessment Tool, the Eating and Drinking Ability Classification System.
During the second research visit, which will take place on a day convenient for the caregiver, the researcher will obtain swallowing accuracy and temporal data using the BiSSkApp or its earlier version - software (BiSSkiT) installed on the researcher’s laptop. The child will be instructed to swallow saliva 10 times to produce swallowing accuracy data. Immediately afterwards, the child will be asked to swallow their saliva five times, followed by swallowing five teaspoons of liquid (only if the child has liquids in their diet). This will produce swallowing temporal data. Afterwards, the caregiver will be taught and asked to administer the child’s training session.

DESCRIPTION OF INTERVENTION/EXPOSURE: Home-based swallowing skill training (one session) that involves:
During the visit to the child's home, the researcher will teach the child's caregiver how to supervise the child's swallowing skill training session. Then, the caregiver will be asked to supervise the session, which takes 25 minutes. The swallowing skill training will involve the child producing 40 swallows. The researcher will present in the same room during the session. The current pilot study involves only a single session, no further swallowing training sessions will be administered until a future larger study is initiated.
The training equipment is 1) a tablet/iPad with an installed Biofeedback in Strength and Skill Application (BiSSkApp) (Swaltech Ltd, New Zealand) and 2) a wireless submental electrode on an adhesive base to track muscle activity during the swallowing training session for 25 minutes.
Intervention code [1] 328568 0
Early detection / Screening
Intervention code [2] 328681 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 338212 0
Tolerance of a submental surface electromyography sensor of the BiSSkApp (Biofeedback in Strength and Skill Application)
Timepoint [1] 338212 0
After a single session of the biofeedback swallowing training at the second research visit
Primary outcome [2] 338213 0
Percentage of positive feedback
Timepoint [2] 338213 0
After a single session of the biofeedback swallowing training at the second research visit
Primary outcome [3] 338430 0
Percentage of positive feedback
Timepoint [3] 338430 0
After a single session of the biofeedback swallowing training at the second research visit
Secondary outcome [1] 435313 0
This is an additional primary outcome. The ability of children to complete the training session
Timepoint [1] 435313 0
After a single session of the biofeedback swallowing training at the second research visit

Eligibility
Key inclusion criteria
Paediatric participants:
1) Age between 7 and 17 years 11 months
2) Diagnosis of Infantile Cerebral Palsy (Gross Motor Function Classification System level I-III)
3) Ability to follow instructions
4) Ability to see
5) Parental complaints about their children’s mealtime
6) Child has a cognitive level to demonstrate his/her preference through negative or positive behaviour
Minimum age
7 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

Study design
Purpose of the study
Diagnosis
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
Safety/efficacy
Statistical methods / analysis
We will track feasibility by identifying the tolerance of the adhesive submental electrode, tracing the EMG signal (keeping it in place until the session ends in 70% or more of participants), the ability of children to complete the training session (completion of at least 70% of swallowing trials [n=28 swallows] per session in 70% or more of participants) and the percentage of positive feedback from the child and caregiver regarding the App implementation (70% of participants or above). The reliability of the SSF, TWST and the TOMASS will be established by determining their intrarater, interrater and test-retest reliability. We hypothesise that 1) home-based biofeedback training will be feasible in children with CP when delivered as a single session and 2) the SSF, the TWST and TOMASS will show to be reliable tests (ICC = 0.70).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2024
Actual
Date of last participant enrolment
Anticipated
15/11/2025
Actual
Date of last data collection
Anticipated
30/11/2025
Actual
Sample size
Target
27
Accrual to date
Final
Recruitment outside Australia
Country [1] 26300 0
New Zealand
State/province [1] 26300 0

Funding & Sponsors
Funding source category [1] 316487 0
Self funded/Unfunded
Name [1] 316487 0
Country [1] 316487 0
Primary sponsor type
Individual
Name
Dr. Ksenia Bykova
Address
Country
New Zealand
Secondary sponsor category [1] 318664 0
None
Name [1] 318664 0
Address [1] 318664 0
Country [1] 318664 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 315285 0
Northern B Health and Disability Ethics Committee 
Ethics committee address [1] 315285 0
https://ethics.health.govt.nz/about/northern-b-health-and-disability-ethics-committee/
Ethics committee country [1] 315285 0
New Zealand
Date submitted for ethics approval [1] 315285 0
24/04/2024
Approval date [1] 315285 0
Ethics approval number [1] 315285 0

Summary
Brief summary
The proposed research will identify 1) the feasibility of home-based biofeedback training of swallowing skills provided as a single session among children with cerebral palsy (CP) and dysphagia and 2) the reliability of three clinical tests to evaluate swallowing of saliva, liquid, and solid, which are currently used in adults with dysphagia and healthy children.

Based on the obtained results, we will review inclusion and exclusion criteria, the data acquisition procedure, and the duration of a biofeedback training session.

In case of success, a future study will investigate the feasibility and effectiveness of the complete two-week protocol of the at-home swallowing skill training. That will have preliminary data that may allow SLPs to provide families of children with CP with a convenient and effective option for dysphagia management at their homes that does not require children’s families to commute to SLP treatment sessions and will also reduce SLPs’ waiting lists.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 134222 0
Dr Ksenia Bykova
Address 134222 0
Rose Centre, St George's Medical Centre, Leinster Chambers, Level One 249 Papanui Rd, Merivale Christchurch 8014 New Zealand
Country 134222 0
New Zealand
Phone 134222 0
+64 33695124
Fax 134222 0
Email 134222 0
[email protected]
Contact person for public queries
Name 134223 0
Ksenia Bykova
Address 134223 0
Rose Centre, St George's Medical Centre, Leinster Chambers, Level One 249 Papanui Rd, Merivale Christchurch 8014 New Zealand
Country 134223 0
New Zealand
Phone 134223 0
+64 33695124
Fax 134223 0
Email 134223 0
[email protected]
Contact person for scientific queries
Name 134224 0
Ksenia Bykova
Address 134224 0
Rose Centre, St George's Medical Centre, Leinster Chambers, Level One 249 Papanui Rd, Merivale Christchurch 8014 New Zealand
Country 134224 0
New Zealand
Phone 134224 0
+64 33695124
Fax 134224 0
Email 134224 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?
All of the individual participant data collected during the trial, after anonymization
When will data be available (start and end dates)?
Start date: data collection termination. End date: 10 years after a participants turns 16 years old.
Available to whom?
Members of the Rose Centre at the University of Canterbury
Available for what types of analyses?
If participants agree on the consent form, the paediatric participant's anonymized information can be used for future research related to swallowing or cerebral palsy.
How or where can data be obtained?
By contacting the primary investigator at [email protected]


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.