Effect of Masgutova Neurosensorimotor Reflex Integration on Oro-Motor Functional Skills in Children With Cerebral

February 16, 2025 updated by: hibatuallah ehab, Cairo University

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The purpose of the study is to investigate the effect of MNRI on:

  1. Oro-motor functional skills with different food textures in children with cerebral palsy
  2. Feeding level
  3. Drooling

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Giza, Egypt
        • Recruiting
        • Faculty of Physical Therapy Cairo University
        • Contact:
          • cairo university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:1. Children with spastic CP both sexes 2. Both sexes 3. Age ranged from 1 to 3years and 9 months. 4. Having oromotor dysfunction and drooling. 5. Having dysphagia ranging from level 4 to 6 on FOIS. -

Exclusion Criteria:

- 1. Congenital problems of mouth and soft plate. 2. Any surgical intervention of head or mouth.

3. Gum Disorders (e.g. gingivitis). 4. Epilepsy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study Arm
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
Other: Oro motor excercise to study arms and controoled arms
Each child in both groups will receive OME program for 30 minutes three times per week for 6 months.
Other: controlled arm
Each child in both groups will receive OME program for 30 minutes three times per week for 6 months.
Other: Oro motor excercise to study arms and controoled arms
Each child in both groups will receive OME program for 30 minutes three times per week for 6 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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).
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 31, 2024

Primary Completion (Estimated)

April 30, 2025

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

February 16, 2025

First Submitted That Met QC Criteria

February 16, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 16, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OME and Masgutova method

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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