- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05792709
Effects of Oral Motor Therapy in Children With Cerebral Palsy
March 19, 2023 updated by: Hafiza Shabnum Noor, Riphah International University
Effects of Oral Motor Therapy in Children With Cerebral Palsy ; A Randomized Control Trial
: CP is a neurodevelopmental condition.
A set of irreversible impairments of movement and posture development, resulting in activity limitation.
Acquired CP can be the outcome of a variety of issues that arise after the first 28 days of a baby's existence.
A CP diagnosis can now be made as early as 16 weeks.
speech-language pathologists (SLPs) began collaborating with OTs and PTs for Infants and toddlers who also struggle with speech impediments, feeding and swallowing disorder.
Oral motor exercises (OMEs), also known as "mouth exercises," "non-speech oral motor training," and "oral motor treatment" were designed for their treatment.
The objective of this study was to assess the effects of oral motor exercises in children with cerebral palsy having feeding and swallowing difficulties.
Study Overview
Detailed Description
Over 17 million people throughout the world are living with cerebral palsy (CP), making it the most common physical disability among children.
CP is a neurodevelopmental condition[1].
Cerebral palsy is a fitting classification of the condition and its associated deficits because the word cerebral means "pertaining to the brain" and palsy means "loss of muscle control."
A set of irreversible impairments of movement and posture development, resulting in activity limitation, that are linked to non-progressive disruptions that occurred in the developing foetus or infant brain, was chosen as the official definition of CP in 2005 by the International Consensus [2].
It's important to keep in mind that the phrase "cerebral palsy" refers to a spectrum of conditions, each of which has its own unique appearance, set of symptoms, and prevalence rate within the general population.
In addition to the musculoskeletal and neurological symptoms of CP, epilepsy and other sensory and cognitive impairments are also common
Study Type
Interventional
Enrollment (Actual)
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 Locations
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Lahore, Pakistan
- Hafiza Shabnum Noor
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Punjab
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Lahore, Punjab, Pakistan
- Hafiza Shabnum Noor
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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
4 years to 13 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- CP children already diagnosed with feeding and swallowing difficulties.
- Age range: 4 to13 years
Exclusion Criteria:
- Patients with any co morbid conditions like uncontrolled epilepsy.
- Patients on NG or feeding tube.
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 |
|---|---|
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Experimental: Oral Motor Therapy
These are exercises designed to increase the range of movement in tongue, lips, and jaw, which helped in speech and/or swallow functioning.
It is important to move the designated area as far as can in each direction until feel the muscles stretch.
Stop if feel any pain, and mention it to speech therapist or doctor.
Practice these exercises, once through, 10 times a day.
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In Traditional therapy we will give cognitive and articulation therapy to the patients.
Other Names:
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Other: Traditional Therapy
weeks traditional Speech Therapy was provided.
Pre-language skills (vocalizations) manual sign languages, gestures, picture communication boards, voice output communication devices were used.
Playing and talking, using pictures, books, objects, or ongoing events to help language development.
Use of repetition exercises to build speech and language skills.
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In Traditional therapy we will give cognitive and articulation therapy to the patients.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Feeding Oral Motor scale
Time Frame: upto 16 weeks
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This tool is used to evaluate the posture, jaw mobility, tongue activity, lips, feeding behavior, abnormal reflexes and breathing control
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upto 16 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Drooling severity and frequency scale
Time Frame: upto 24 weeks
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This tool is used to check the severity of drooling
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upto 24 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ghazal Awais, MS-SLP, Riphah International University
- Principal Investigator: Hafiza Shabnum Noor, MS-SLP, 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
- Turra GS, Schwartz IVD, Almeida ST, Martinez CC, Bridi M, Barreto SSM. Efficacy of speech therapy in post-intubation patients with oropharyngeal dysphagia: a randomized controlled trial. Codas. 2021 Apr 26;33(2):e20190246. doi: 10.1590/2317-1782/20202019246. eCollection 2021.
- Sigan SN, Uzunhan TA, Aydinli N, Eraslan E, Ekici B, Caliskan M. Effects of oral motor therapy in children with cerebral palsy. Ann Indian Acad Neurol. 2013 Jul;16(3):342-6. doi: 10.4103/0972-2327.116923.
Helpful Links
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 16, 2022
Primary Completion (Actual)
February 27, 2023
Study Completion (Actual)
February 27, 2023
Study Registration Dates
First Submitted
February 26, 2023
First Submitted That Met QC Criteria
March 19, 2023
First Posted (Actual)
March 31, 2023
Study Record Updates
Last Update Posted (Actual)
March 31, 2023
Last Update Submitted That Met QC Criteria
March 19, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR & AHS/22/0646
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Study Data/Documents
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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