EFFECT OF NEUROMUSCULAR ELECTRICAL STIMULATION ON DYSPHAGIA IN CHILDREN WITH DOWN SYNDROME

NCT ID: NCT05277142

Last Updated: 2022-03-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-23
• Study Completion Date: 2022-12-15

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.

Conditions

Rehabilitation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group (A)

they received oral motor training for 40 minutes 3 times/week for twelve successive weeks.

Group Type: EXPERIMENTAL

oral motor training

Intervention Type: OTHER

they received oral motor training for 40 minutes 3 times/week for twelve successive weeks.

Group (B)

They received the same Oral motor training program of Group A for 20 minutes in addition to Neuromuscular Electrical Stimulation (NMES) at intensity ranged from (3-5mA) duration for 20 minutes and frequency of 80 HZ 3 times/week for twelve successive weeks.

Group Type: EXPERIMENTAL

oral motor training

Intervention Type: OTHER

they received oral motor training for 40 minutes 3 times/week for twelve successive weeks.

Neuromuscular Electrical Stimulation

Intervention Type: DEVICE

They received the same Oral motor training program of Group A for 20 minutes in addition to Neuromuscular Electrical Stimulation (NMES) at intensity ranged from (3-5mA) duration for 20 minutes and frequency of 80 HZ 3 times/week for twelve successive weeks

Interventions

oral motor training

they received oral motor training for 40 minutes 3 times/week for twelve successive weeks.

Intervention Type: OTHER

Neuromuscular Electrical Stimulation

They received the same Oral motor training program of Group A for 20 minutes in addition to Neuromuscular Electrical Stimulation (NMES) at intensity ranged from (3-5mA) duration for 20 minutes and frequency of 80 HZ 3 times/week for twelve successive weeks

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

October 6 University

OTHER

Sponsor Role: lead

Responsible Party

Walid Saber Hussain

assistant lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Emad

Giza, , Egypt

Countries

Egypt

Other Identifiers

7689

Identifier Type: -

Identifier Source: org_study_id