NCT05792709

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 16, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 26, 2023

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 27, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 27, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 31, 2023

Completed
Last Updated

March 31, 2023

Status Verified

March 1, 2023

Enrollment Period

7 months

First QC Date

February 26, 2023

Last Update Submit

March 19, 2023

Conditions

Keywords

Oral Motor TherapyCerebral palsyDrooling scaleFeeding and Swallowing

Outcome Measures

Primary Outcomes (1)

  • Feeding Oral Motor scale

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

    upto 16 weeks

Secondary Outcomes (1)

  • Drooling severity and frequency scale

    upto 24 weeks

Study Arms (2)

Oral Motor Therapy

EXPERIMENTAL

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.

Other: Oral Motor Therapy

Traditional Therapy

OTHER

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.

Other: Oral Motor Therapy

Interventions

In Traditional therapy we will give cognitive and articulation therapy to the patients.

Also known as: Traditional Therapy
Oral Motor TherapyTraditional Therapy

Eligibility Criteria

Age4 Years - 13 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • CP children already diagnosed with feeding and swallowing difficulties.
  • Age range: 4 to13 years

You may not qualify if:

  • Patients with any co morbid conditions like uncontrolled epilepsy.
  • Patients on NG or feeding tube.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hafiza Shabnum Noor

Lahore, Punjab Province, Pakistan

Location

Hafiza Shabnum Noor

Lahore, Pakistan

Location

Related Publications (2)

  • 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.

    PMID: 33909759BACKGROUND
  • 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.

    PMID: 24101813BACKGROUND

Related Links

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Ghazal Awais, MS-SLP

    Riphah International University

    PRINCIPAL INVESTIGATOR
  • Hafiza Shabnum Noor, MS-SLP

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Lecturer

Study Record Dates

First Submitted

February 26, 2023

First Posted

March 31, 2023

Study Start

August 16, 2022

Primary Completion

February 27, 2023

Study Completion

February 27, 2023

Last Updated

March 31, 2023

Record last verified: 2023-03

Locations