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Effects of Oral Motor Therapy in Children With Cerebral Palsy

Primary Purpose

Cerebral Palsy

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Oral Motor Therapy
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy focused on measuring Oral Motor Therapy, Cerebral palsy, Drooling scale, Feeding and Swallowing

Eligibility Criteria

4 Years - 13 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hafiza Shabnum Noor
  • Hafiza Shabnum Noor

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Oral Motor Therapy

Traditional Therapy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Feeding Oral Motor scale
This tool is used to evaluate the posture, jaw mobility, tongue activity, lips, feeding behavior, abnormal reflexes and breathing control

Secondary Outcome Measures

Drooling severity and frequency scale
This tool is used to check the severity of drooling

Full Information

First Posted
February 26, 2023
Last Updated
March 19, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05792709
Brief Title
Effects of Oral Motor Therapy in Children With Cerebral Palsy
Official Title
Effects of Oral Motor Therapy in Children With Cerebral Palsy ; A Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
August 16, 2022 (Actual)
Primary Completion Date
February 27, 2023 (Actual)
Study Completion Date
February 27, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
: 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
Oral Motor Therapy, Cerebral palsy, Drooling scale, Feeding and Swallowing

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
All patients of study were screened for following information before randomization such as age, gender, location duration of disease and medical history. Each participant of current study was undergoing through questionnaire regarding demographic information. For oral motor therapy assessment and the Functional Feeding Assessment (FFA) subscale of the multidisciplinary Feeding Profile (MFP) were used. A blinded pedagogue who was not involve in the training sessions performed the Bayley scales of infant development (BSID-II) before and after the training.
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oral Motor Therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Traditional Therapy
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Oral Motor Therapy
Other Intervention Name(s)
Traditional Therapy
Intervention Description
In Traditional therapy we will give cognitive and articulation therapy to the patients.
Primary Outcome Measure Information:
Title
Feeding Oral Motor scale
Description
This tool is used to evaluate the posture, jaw mobility, tongue activity, lips, feeding behavior, abnormal reflexes and breathing control
Time Frame
upto 16 weeks
Secondary Outcome Measure Information:
Title
Drooling severity and frequency scale
Description
This tool is used to check the severity of drooling
Time Frame
upto 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ghazal Awais, MS-SLP
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hafiza Shabnum Noor, MS-SLP
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hafiza Shabnum Noor
City
Lahore
State/Province
Punjab
Country
Pakistan
Facility Name
Hafiza Shabnum Noor
City
Lahore
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33909759
Citation
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.
Results Reference
background
PubMed Identifier
24101813
Citation
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.
Results Reference
background
Links:
URL
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3788277/
Description
Study Protocol
Available IPD and Supporting Information:
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3788277/

Learn more about this trial

Effects of Oral Motor Therapy in Children With Cerebral Palsy

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