Clinical trial NCT05277142: EFFECT OF NEUROMUSCULAR ELECTRICAL STIMULATION ON DYSPHAGIA IN CHILDREN WITH DOWN SYNDROME
Official title: EFFECT OF NEUROMUSCULAR ELECTRICAL STIMULATION ON DYSPHAGIA IN CHILDREN WITH DOWN SYNDROME
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rehabilitation
Lead sponsor: October 6 University
Sponsor class: OTHER
First posted: 2022-03-14
Enrollment: 64
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Although some western studies have been conducted to determine the nature of eating problems and oral motor training in children with Down syndrome, these studies are limited. Most of the studies were done in Down syndrome infants. Since feeding is a skill that develops by 2 years of age and refines till 6 years of age (Delaney \& Arvedson 2008), it is essential to study the children in this age group as well. Moreover, there is a dearth of studies investigating the impact of oral motor exercises on feeding problems of the child, which may, in turn, hinder the progress of the child during the intervention. Blissett J., (2018) reported that the behaviours of both caretaker, therapist and infant during feeding contribute significantly to the overall success of the feeding interaction as well as feeding performance. Parents/caregivers play an important role in feeding the child, as they have the first-hand exposure and experience in feeding their child, awareness of the child's feeding behaviours, likes and dislikes of food and communication behaviour during hunger. Consequently, they are the best people to describe their child's feeding problems. Hence, this study involves the administration of a scale on the parent/caregiver to elicit information about the physical, functional and emotional aspects of drooling. Such studies in the Egyptian context are limited. The paucity of literature makes it clear that there are deeper underlying complex issues about oral motor exercises in children with Down syndrome that needs to be investigated. The in-depth assessment and treatment of oral motor skills will provide valuable input to the physical therapists during the treatment of feeding problems in children with Down syndrome. This would help the therapist and clinician in planning and prioritizing the goals during therapy. The information will also help in counselling the caregivers, deciding the success or failure of feeding therapy and thereby help in predicting the prognosis of the child.


Eligibility criteria: Inclusion Criteria:

* 1- Their age ranged from 3 to 6 years. 2- Both genders were included. 3- The participating children having the ability to understand and follow simple instructions (IQ level not less than 50).

  4- They did not have any visual or auditory problems. 5- They did not be treated with special medications affecting mental functions. 6- They had score from 4 to 7 according to functional oral intake scale.

Exclusion Criteria:

* 1- Children with history of epilepsy. 2- Children with dental deformities. 3- Children with chest infections or unstable cardiac status. 4- Children with infective skin conditions. 5- Children with gum disorders.

Primary outcomes:
measure: 1- Oral Motor Assessment Scale
timeFrame: 12 weeks
measure: 2- Pediatric Eating Assessment Tool- Pedi EAT
timeFrame: 12 weeks
measure: 3- Pediatric Eating Assessment Tool
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Emad
Study officials:
References: