Oro-motorNCT06838403
Effect of Masgutova Neurosensorimotor Reflex Integration on Oro-Motor Functional Skills in Children With Cerebral
A study testing Oro motor excercise to study arms and controoled arms in people with Oro-motor and MNRI, run by Cairo University at 1 site in Egypt.
Trial summary
Cerebral palsy (CP) is a disorder of movement and/or posture caused by a non-progressive brain lesion that persists through the lifespan and has a prevalence of more than 2 per 1000 live births (Oskoui et al., 2013). Read more about this study
- Who is it for?
- Ages 1 year to 4 years
- Conditions the study is for
- Oro-motor, MNRI, CP (Cerebral Palsy)
- What is being tested?
- Oro motor excercise to study arms and controoled arms
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 31 Aug 2024to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 1 year to 4 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
None listed.
Who cannot join
- 1. Congenital problems of mouth and soft plate. 2. Any surgical intervention of head or mouth.
- 3. Gum Disorders (e.g. gingivitis). 4. Epilepsy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
faculty of physical therapy Cairo university
Giza
cairo university
About this study
Cerebral palsy (CP) is a disorder of movement and/or posture caused by a non-progressive brain lesion that persists through the lifespan and has a prevalence of more than 2 per 1000 live births (Oskoui et al., 2013). It comprises a heterogeneous group of impairments that may also affect the oral motor functions needed for eating, drinking, swallowing, and articulation (Romano et al., 2017). Dysphagia is a swallowing problem that can influence the safety and efficiency of feeding. This may lead to inadequate nutritional status due to prolonged feeding times (Mishra et al., 2018), stress during mealtimes for the caregiver and/or the child, and impaired growth (Cousino and Hazen, 2013; Stevenson et al, 2006). Estimates of the prevalence of dysphagia in children with CP vary widely due to the different definitions and tools used, variability in severity of CP, and motor type. The prevalence ranges from 21% in a group of 1357 children with CP (Parkes et al., 2010), to 99% in a group of 166 severely affected children with intellectual impairment (Calis et al., 2008). Children with CP commonly have feeding disorders and dysphagia that in many instances place them at risk for aspiration with oral feeding, with potential pulmonary consequences. They also commonly have reduced nutrition/ hydration status and prolonged stressful mealtimes. The specific nature and severity of the swallowing problems may differ, at least to some degree, in relation to sensorimotor impairment, gross and fine motor limitations, and cognitive/ communication deficits. Children with generalized severe motor impairment (for 2
example, spastic quadriplegia) are likely to experience greater swallowing deficits (Calis et al., 2008; Parkes et al., 2010). Oropharyngeal dysphagia may be characterized by problems in any or all phases of swallowing (Arvedson et al., 2019). The oral cavity and pharynx are anatomically separate but functionally integrated, the two regions are involved in complex motor responses that include feeding, chewing, swallowing, speech, and respiration. The multiple sensory receptors that innervate these two regions provide the first link in reflexes that control muscles of the entire head, upper gastrointestinal tract, and airway. Most of the reflexes affect the diversity of muscles that compose the tongue, which is vital to all stages of feeding, and which continually affects the patency of the airway (Miller, 2002). The types of oral and pharyngeal problems that children with CP have include reduced lip closure, poor tongue function, tongue thrust, exaggerated bite reflex, tactile hypersensitivity, delayed swallow initiation, reduced pharyngeal motility and drooling. Impaired oral sensorimotor function can result in drooling that in turn results in impaired hydration (Santos et al., 2012). The Schedule for Oral Motor Assessment (SOMA) is an assessment tool developed for the objective assessment of oral motor function in infants, with proven reliability and validity clinical setting. The SOMA is an assessment tool designed for the objective evaluation of oral-motor functions in children, with proven reliability and validity in infants aged 8-24 months. For the 5 types of test diet, based on the cutting score after assessment in each category, subjects are classified into normal or abnormal oral-motor function groups (Reilly et al., 1995). Oral motor rehabilitation therapy in children with CP aims at reducing or eliminating swallowing disorders and promoting functional feeding (Novak et al., 2020). Some studies suggest that intervention with oral motor therapy (OMT) or oro-motor exercise (OME) has a beneficial effect on functional independence levels and improves the quality of life of patients with feeding and swallowing 3 disorder (FSD) (Sığan et al., 2013; Howe and Wang, 2013). The Masgutova Neurosensorimotor reflex integration (MNRI) Facial Reflex Integration course is directed to the specific primary reaction of facial reflexes and their integration with whole movement development and learning. It arises from the basic Neurosensorimotor Reflex Integration concept that addresses the enhancement of learning through developing movement
Read the detailed description
The purpose of the study is to investigate the effect of MNRI on:
- Oro-motor functional skills with different food textures in children with cerebral palsy
- Feeding level
- Drooling
- Conditions
- Oro-motor, MNRI, CP (Cerebral Palsy), OME, Masgutova Method
- Being tested
- Oro motor excercise to study arms and controoled arms
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oro motor excercise to study arms and controoled armsOther
Each child in both groups will receive OME program for 30 minutes three times per week for 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Study Arm | Experimental | Each child in the study group will receive OME program in addition to 15 minutes MNRI technique for three times per week for 6 weeks Receives: Other: Oro motor excercise to study arms and controoled arms |
| controlled arm | Other | Each child in both groups will receive OME program for 30 minutes three times per week for 6 months. Receives: Other: Oro motor excercise to study arms and controoled arms |
What is being measured
The primary outcome is the main question the study is designed to answer.
Schedual for oromotor Assessment ( SOMA )
The SOMA is divided into four main components:
- Oral motor challenge categories
- Functional areas
- Functional units
- Discrete oral motor behaviors. Oral motor challenge categories (OMC) refer to the graded textures presented to the infant. There are seven OMC categories:
- Puree.
- Semi-solids.
- Solids.
- Bottle.
- Trainer cup.
- Cup.
- Crackers.
Measured: baseline
The Drooling Severity and Frequency Scale (DSFS) is a semi-quantitative assessment of the amount of drooling. It originally was developed to measure frequency and severity of drooling in individuals with cerebral palsy. Subsequently, it has been used in
he DSFS consists of 2 questions. The first question rates severity on a five-point (1-5) scale (never drools, mild, moderate, severe, or profuse). The second question rates drooling on a four-point (1-4) scale (no drooling, occasional, frequent, or constant). The Drooling Score equals the sum of the Severity and Frequency sub-scores (range 2-9).
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2025
- Study start31 Aug 2024
- Primary completion30 Apr 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oro-motorStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, hibatuallah ehab, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06838403
- Sponsor's protocol ID
- OME and Masgutova method
- Status last verified
- Feb 2025
- First submitted
- 16 Feb 2025
- Last updated
- 20 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Masgutova Neurosensorimotor Reflex Integration on Oro-Motor Functional Skills in Children With Cerebral
- ClinicalTrials.gov ID
- NCT06838403
- Acronym / sponsor ID
- OME and Masgutova method
- Conditions
- Oro-motor, MNRI, CP (Cerebral Palsy), OME, Masgutova Method
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 31 Aug 2024 (actual)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 20 Feb 2025 (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.
Cerebral palsy (CP) is a disorder of movement and/or posture caused by a non-progressive brain lesion that persists through the lifespan and has a prevalence of more than 2 per 1000 live births (Oskoui et al., 2013). It comprises a heterogeneous group of impairments that may also affect the oral motor functions needed for eating, drinking, swallowing, and articulation (Romano et al., 2017). Dysphagia is a swallowing problem that can influence the safety and efficiency of feeding. This may lead to inadequate nutritional status due to prolonged feeding times (Mishra et al., 2018), stress during mealtimes for the caregiver and/or the child, and impaired growth (Cousino and Hazen, 2013; Stevenson et al, 2006). Estimates of the prevalence of dysphagia in children with CP vary widely due to the different definitions and tools used, variability in severity of CP, and motor type. The prevalence ranges from 21% in a group of 1357 children with CP (Parkes et al., 2010), to 99% in a group of 166 severely affected children with intellectual impairment (Calis et al., 2008). Children with CP commonly have feeding disorders and dysphagia that in many instances place them at risk for aspiration with oral feeding, with potential pulmonary consequences. They also commonly have reduced nutrition/ hydration status and prolonged stressful mealtimes. The specific nature and severity of the swallowing problems may differ, at least to some degree, in relation to sensorimotor impairment, gross and fine motor limitations, and cognitive/ communication deficits. Children with generalized severe motor impairment (for 2
example, spastic quadriplegia) are likely to experience greater swallowing deficits (Calis et al., 2008; Parkes et al., 2010). Oropharyngeal dysphagia may be characterized by problems in any or all phases of swallowing (Arvedson et al., 2019). The oral cavity and pharynx are anatomically separate but functionally integrated, the two regions are involved in complex motor responses that include feeding, chewing, swallowing, speech, and respiration. The multiple sensory receptors that innervate these two regions provide the first link in reflexes that control muscles of the entire head, upper gastrointestinal tract, and airway. Most of the reflexes affect the diversity of muscles that compose the tongue, which is vital to all stages of feeding, and which continually affects the patency of the airway (Miller, 2002). The types of oral and pharyngeal problems that children with CP have include reduced lip closure, poor tongue function, tongue thrust, exaggerated bite reflex, tactile hypersensitivity, delayed swallow initiation, reduced pharyngeal motility and drooling. Impaired oral sensorimotor function can result in drooling that in turn results in impaired hydration (Santos et al., 2012). The Schedule for Oral Motor Assessment (SOMA) is an assessment tool developed for the objective assessment of oral motor function in infants, with proven reliability and validity clinical setting. The SOMA is an assessment tool designed for the objective evaluation of oral-motor functions in children, with proven reliability and validity in infants aged 8-24 months. For the 5 types of test diet, based on the cutting score after assessment in each category, subjects are classified into normal or abnormal oral-motor function groups (Reilly et al., 1995). Oral motor rehabilitation therapy in children with CP aims at reducing or eliminating swallowing disorders and promoting functional feeding (Novak et al., 2020). Some studies suggest that intervention with oral motor therapy (OMT) or oro-motor exercise (OME) has a beneficial effect on functional independence levels and improves the quality of life of patients with feeding and swallowing 3 disorder (FSD) (Sığan et al., 2013; Howe and Wang, 2013). The Masgutova Neurosensorimotor reflex integration (MNRI) Facial Reflex Integration course is directed to the specific primary reaction of facial reflexes and their integration with whole movement development and learning. It arises from the basic Neurosensorimotor Reflex Integration concept that addresses the enhancement of learning through developing movement
Detailed description
The purpose of the study is to investigate the effect of MNRI on:
- Oro-motor functional skills with different food textures in children with cerebral palsy
- Feeding level
- Drooling
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Arm | Experimental | Other: Oro motor excercise to study arms and controoled armsEach child in the study group will receive OME program in addition to 15 minutes MNRI technique for three times per week for 6 weeks |
| controlled arm | Other | Other: Oro motor excercise to study arms and controoled armsEach child in both groups will receive OME program for 30 minutes three times per week for 6 months. |
Who may qualify
- Ages
- 1 year to 4 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- 1. Congenital problems of mouth and soft plate. 2. Any surgical intervention of head or mouth.
- 3. Gum Disorders (e.g. gingivitis). 4. Epilepsy.
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 |
|---|---|---|
| Oro motor excercise to study arms and controoled armsEach child in both groups will receive OME program for 30 minutes three times per week for 6 months. | Other | Study Arm, controlled arm |
Primary outcome
Schedual for oromotor Assessment ( SOMA )
Time frame: baseline
The SOMA is divided into four main components: * Oral motor challenge categories * Functional areas * Functional units * Discrete oral motor behaviors. Oral motor challenge categories (OMC) refer to the graded textures presented to the infant. There are seven OMC categories: 1. Puree. 2. Semi-solids. 3. Solids. 4. Bottle. 5. Trainer cup. 6. Cup. 7. Crackers.
The Drooling Severity and Frequency Scale (DSFS) is a semi-quantitative assessment of the amount of drooling. It originally was developed to measure frequency and severity of drooling in individuals with cerebral palsy. Subsequently, it has been used in
Time frame: baseline
he DSFS consists of 2 questions. The first question rates severity on a five-point (1-5) scale (never drools, mild, moderate, severe, or profuse). The second question rates drooling on a four-point (1-4) scale (no drooling, occasional, frequent, or constant). The Drooling Score equals the sum of the Severity and Frequency sub-scores (range 2-9).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2025.
- Individual participant dataSharing planned: Undecided
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oro motor excercise to study arms and controoled arms in people with Oro-motor and MNRI, run by Cairo 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 0 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 20 Feb 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hebatuallah ehab zedain (+201017335233, heba.ehab92@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Schedual for oromotor Assessment ( SOMA ) (time frame: baseline). The study lists 2 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 20 Feb 2025.