None listed
Conditions
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.
Interventions
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 compl
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.
Sponsors
Dr. Ksenia Bykova
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
7 Years to No maximum
Healthy volunteers
No
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
Exclusion criteria
None
Outcome results
None listed