Oral Motor Facilitation Technique And Traditional Exercises on Children With Cerebral Palsy

April 2, 2024 updated by: Riphah International University

Effects Of Oral Motor Facilitation Technique And Traditional Exercises On Drooling And Feeding Skills Of Children With Cerebral Palsy

Cerebral palsy is a motor disorder caused by the damage to the developing brain. Feeding and swallowing difficulties are common in children with cerebral palsy (CP). Poor postural control and oral motor dysfunction results in extended feeding time, frequent coughing, choking and excessive drooling affecting their health and quality of life. The brain damage in CP is permanent that cannot be fixed however different oral motor exercises, oral facial facilitation and oral sensorimotor interventions are widely used for drool reduction and feeding difficulties in children with CP. Spastic cerebral palsy is one of most prevalent type of CP that is characterized by increased tone and stiffness of muscles. This research will be conducted to evaluate the comparative effects of oral motor facilitation technique (OMFT) and traditional oral motor exercises on drooling and feeding skills of children with spastic CP. OMFT is a complete protocol with a combination of techniques to deal with oral motor difficulties This study will be a randomized control trial. A total number of 12 children with Spastic cerebral palsy ( GMFS III-V) both male/female, between age range 3-12 and with feeding difficulties will be included in the study. Children with cerebral palsy and other co morbidities, seizures, risk of aspiration and who are on tube feeding will be excluded. Participants will be randomly allocated to two groups, either Group A (receiving OMFT) or Group B (receiving traditional oral motor exercise). Baseline scores will be recorded by using standardized tools OMAS for oral motor skill during feeding and DIS for drool severity with the consent of authors. Therapeutic sessions will be scheduled 3 days per week and 30 min a day for each group. The effects of interventions on drooling and feeding skills will be assessed after 8 and 16 weeks of sessions. Recorded data of all variables will be analyzed by using statistical package for social sciences (SPSS) for Windows Software, version 21.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Cerebral palsy is a motor disorder caused by the damage to the developing brain. Feeding and swallowing difficulties are common in children with cerebral palsy (CP). Poor postural control and oral motor dysfunction results in extended feeding time, frequent coughing, choking and excessive drooling affecting their health and quality of life. The brain damage in CP is permanent that cannot be fixed however different oral motor exercises, oral facial facilitation and oral sensorimotor interventions are widely used for drool reduction and feeding difficulties in children with CP. Spastic cerebral palsy is one of most prevalent type of CP that is characterized by increased tone and stiffness of muscles. This research will be conducted to evaluate the comparative effects of oral motor facilitation technique (OMFT) and traditional oral motor exercises on drooling and feeding skills of children with spastic CP. OMFT is a complete protocol with a combination of techniques to deal with oral motor difficulties This study will be a randomized control trial. A total number of 12 children with Spastic cerebral palsy ( GMFS III-V) both male/female, between age range 3-12 and with feeding difficulties will be included in the study. Children with cerebral palsy and other co morbidities, seizures, risk of aspiration and who are on tube feeding will be excluded. Participants will be randomly allocated to two groups, either Group A (receiving OMFT) or Group B (receiving traditional oral motor exercise). Baseline scores will be recorded by using standardized tools OMAS for oral motor skill during feeding and DIS for drool severity with the consent of authors. Therapeutic sessions will be scheduled 3 days per week and 30 min a day for each group. The effects of interventions on drooling and feeding skills will be assessed after 8 and 16 weeks of sessions. Recorded data of all variables will be analyzed by using statistical package for social sciences (SPSS) for Windows Software, version 21.

Study Type

Interventional

Enrollment (Estimated)

10

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

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, 54000
        • Recruiting
        • Mobilty Quest
        • Contact:
        • Principal Investigator:
          • Nazia Mumtaz, PhD
        • Sub-Investigator:
          • Sadaf Safdar, BS

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:

  • Children with cerebral palsy
  • Type: spastic CP
  • Severity level :GMFCS (gross motor function classification scale) level III to V, with head and neck control problems
  • With feeding and oral motor difficulties
  • Gender male/female
  • Age: 3-10 years
  • No past history of receiving OMFT

Exclusion Criteria:

  • CP children with other co morbidities or syndromes
  • risk of aspiration
  • children on tube feeding or with seizures
  • children with craniofacial anomalies

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: oral motor facilitation technique group
Exercise by using OMFT protocol will be given in the order of warming up technique, key point technique and application technique for 30 min a day.
Behavioral: oral motor facilitation technique group
oral motor facilitation technique
Other: traditional oral motor exercises group
Traditional exercises of lips, cheeks, tongue and jaws will be provided for 30 min a day and 3 days/week
Other: traditional oral motor exercises group
traditional oral motor exercises

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Drooling
Time Frame: 16 weeks
Change in drooling of CP children will be measured by using "Drooling Impact scale", a quantitative tool to evaluate the effects of intervention on drool control. It is a 10 item scale with 10 point scoring level from 0 (no impact at all) to 10 (severe impact) to quantify the impact of intervention.
16 weeks
Change in feeding skills
Time Frame: 16 weeks
A change in oral motor skills during feeding after intervention will be evaluated by using "Oral Motor Assessment Scale", a seven item/variable scale and each variable scores from 0 (not functional ) to 3 ( normal function). At the end total score is measured and an increase in score shows the improvement in feeding skills.
16 weeks

Collaborators and Investigators

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

Sponsor

Riphah International University

Investigators

  • Principal Investigator: Nazia Mumtaz, PhD, Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

December 1, 2023

Primary Completion (Estimated)

April 1, 2024

Study Completion (Estimated)

April 1, 2024

Study Registration Dates

First Submitted

December 26, 2023

First Submitted That Met QC Criteria

April 2, 2024

First Posted (Actual)

April 3, 2024

Study Record Updates

Last Update Posted (Actual)

April 3, 2024

Last Update Submitted That Met QC Criteria

April 2, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Sadaf Riphah

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

Clinical Trials on Cerebral Palsy (CP)

Clinical Trials on oral motor facilitation technique group

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Venezuela

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe