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

Primary Purpose

Rehabilitation

Status
Active
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
oral motor training
Neuromuscular Electrical Stimulation
Sponsored by
October 6 University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rehabilitation

Eligibility Criteria

3 Years - 6 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Emad

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group (A)

Group (B)

Arm Description

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

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.

Outcomes

Primary Outcome Measures

1- Oral Motor Assessment Scale
The Oral Motor Assessment Scale (OMAS) are used as an outcome measurement in intervention studies. The scale items were elaborated by a multidisciplinary team comprising dentists and speech therapists. It TEMPhas characteristics dat differentiate it from other scales coz it does not require dat the subject obey commands and it does not include speech assessment
2- Pediatric Eating Assessment Tool- Pedi EAT
Teh Pediatric Eating Assessment Tool (PediEAT) measures symptoms of feeding problems in young children. Content validity was established using DeVellis' methods of scale development (13) through systematic item generation and evaluation by clinical and research experts as well as by teh intended respondents: parents of children both with and without feeding problems
3- Pediatric Eating Assessment Tool
The Pediatric Version of the Eating Assessment Tool (PEDI-EAT-10) is the pediatric version of the 10-item Eating Assessment Tool (EAT-10), which is a reliable and valid dysphagia symptom specific outcome tool The Eating Assessment Tool-10 (EAT-10) is a validated, commonly used tool in clinical practice, which serves for the assessment of symptom-specific outcomes

Secondary Outcome Measures

Full Information

First Posted
March 3, 2022
Last Updated
March 11, 2022
Sponsor
October 6 University
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1. Study Identification

Unique Protocol Identification Number
NCT05277142
Brief Title
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

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 23, 2020 (Actual)
Primary Completion Date
December 1, 2022 (Anticipated)
Study Completion Date
December 15, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
October 6 University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group (A)
Arm Type
Experimental
Arm Description
they received oral motor training for 40 minutes 3 times/week for twelve successive weeks.
Arm Title
Group (B)
Arm Type
Experimental
Arm Description
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
Other
Intervention Name(s)
oral motor training
Intervention Description
they received oral motor training for 40 minutes 3 times/week for twelve successive weeks.
Intervention Type
Device
Intervention Name(s)
Neuromuscular Electrical Stimulation
Intervention Description
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
Primary Outcome Measure Information:
Title
1- Oral Motor Assessment Scale
Description
The Oral Motor Assessment Scale (OMAS) are used as an outcome measurement in intervention studies. The scale items were elaborated by a multidisciplinary team comprising dentists and speech therapists. It TEMPhas characteristics dat differentiate it from other scales coz it does not require dat the subject obey commands and it does not include speech assessment
Time Frame
12 weeks
Title
2- Pediatric Eating Assessment Tool- Pedi EAT
Description
Teh Pediatric Eating Assessment Tool (PediEAT) measures symptoms of feeding problems in young children. Content validity was established using DeVellis' methods of scale development (13) through systematic item generation and evaluation by clinical and research experts as well as by teh intended respondents: parents of children both with and without feeding problems
Time Frame
12 weeks
Title
3- Pediatric Eating Assessment Tool
Description
The Pediatric Version of the Eating Assessment Tool (PEDI-EAT-10) is the pediatric version of the 10-item Eating Assessment Tool (EAT-10), which is a reliable and valid dysphagia symptom specific outcome tool The Eating Assessment Tool-10 (EAT-10) is a validated, commonly used tool in clinical practice, which serves for the assessment of symptom-specific outcomes
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Emad
City
Giza
ZIP/Postal Code
12533
Country
Egypt

12. IPD Sharing Statement

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

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