RehabilitationNCT05277142
EFFECT OF NEUROMUSCULAR ELECTRICAL STIMULATION ON DYSPHAGIA IN CHILDREN WITH DOWN SYNDROME
A study testing oral motor training and Neuromuscular Electrical Stimulation in people with Rehabilitation, run by October 6 University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 6 years
- Conditions the study is for
- Rehabilitation
- What is being tested?
- oral motor training and Neuromuscular Electrical Stimulation
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteEgypt
- Study dates
- 23 Jan 2020to 15 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- oral motor training, Neuromuscular Electrical Stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral motor trainingOther
they received oral motor training for 40 minutes 3 times/week for twelve successive weeks.
Neuromuscular Electrical StimulationDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Group (A) | Experimental | they received oral motor training for 40 minutes 3 times/week for twelve successive weeks. Receives: Other: oral motor training |
| Group (B) | Experimental | 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. Receives: Other: oral motor training; Device: Neuromuscular Electrical Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 weeks
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
Measured: 12 weeks
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
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2022
- Study start23 Jan 2020
- Primary completion1 Dec 2022 (estimated)
- Study completion15 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RehabilitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- October 6 University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Walid Saber Hussain, October 6 University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05277142
- Sponsor's protocol ID
- 7689
- Status last verified
- Mar 2022
- First submitted
- 3 Mar 2022
- Last updated
- 14 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECT OF NEUROMUSCULAR ELECTRICAL STIMULATION ON DYSPHAGIA IN CHILDREN WITH DOWN SYNDROME
- ClinicalTrials.gov ID
- NCT05277142
- Acronym / sponsor ID
- 7689
- Conditions
- Rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (actual)
- Lead sponsor
- October 6 UniversityUniversity, hospital or other
- Study start
- 23 Jan 2020 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 15 Dec 2022 (estimated)
- First posted
- 14 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group (A) | Experimental | Other: oral motor trainingthey received oral motor training for 40 minutes 3 times/week for twelve successive weeks. |
| Group (B) | Experimental | Other: oral motor training, Device: Neuromuscular Electrical StimulationThey 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. |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oral motor trainingthey received oral motor training for 40 minutes 3 times/week for twelve successive weeks. | Other | Group (A), Group (B) |
| Neuromuscular Electrical StimulationThey 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 | Device | Group (B) |
Primary outcome
1- Oral Motor Assessment Scale
Time frame: 12 weeks
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
Time frame: 12 weeks
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
Time frame: 12 weeks
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing oral motor training and Neuromuscular Electrical Stimulation in people with Rehabilitation, run by October 6 University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1- Oral Motor Assessment Scale (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2022.