- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07516860
Effect of SCS Technique on Oromotor Skills in Children With CP
Effect of Strain Counter Strain on Oromotor Functions in Children With Spastic Cerebral Palsy: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study follows a Randomized Controlled Trial (RCT) design. Children with spastic cerebral palsy are screened for inclusion based on impaired oromotor control and persistent neck muscle tension.
The Control Group receives a designed oral motor program aimed at improving oral motor functions, mouth opening, and drooling severity, conducted over 4 weeks (one month).
The Study Group receives the same designed oral motor program, preceded by the Strain Counter-Strain (SCS) technique applied to the masseter, sternocleidomastoid (SCM), scalenes, upper trapezius, and suprahyoid muscles. The SCS technique aims to normalize cervical alignment and release restrictive tension in the orofacial region.
Outcome Measures: Functional and physical changes are assessed at baseline and after the 4-week period. The primary outcomes include:
Mouth opening range (measured in centimeters). Drooling frequency and severity (using standardized scales). Oral motor functions (evaluated through standardized scales). The comparison seeks to demonstrate how stabilizing the proximal postural base through SCS facilitates refined distal oromotor performance
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Giza, Egypt
- Faculty of physical therapy, Cairo University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Chronological age was 4 - 8 years from gender was selected
- Their degrees of spasticity were 1, 1+ according to modified Ashworth scale.
- They had moderate drooling according to modified drooling questionnaire.
- Mouth opening limitation was less than 3 cm.
- Their levels of motor function were II - III- IV according to gross motor function classification system.
- Their levels of feeding abilities were III on Eating and Drinking Ability Classification System.
- Children were able to follow instruction
Exclusion Criteria:
- Any history of jaw, head, and face trauma.
- Facial or dental developmental abnormalities.
- Any history of head and neck surgical intervention.
- Congenital abnormalities of head and neck
Study Plan
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: Strain counter-strain plus oral motor program
This group receives the Strain Counter-Strain (SCS) technique followed by a designed oral motor program.
The intervention targets the masseter, SCM, upper trapezius, scalenes, and suprahyoid muscles to release myofascial tension and normalize cervical alignment, conducted 3 sessions per week for 4 weeks
|
A manual therapy technique used to release myofascial tightness and muscle tension in the head and neck region to provide a stable postural foundation for oromotor skills
A structured exercise program designed to enhance oral motor functions, including feeding efficiency, mouth opening range, and drooling
|
|
Active Comparator: Oral motor program only
This group receives only the designed oral motor program aimed at improving the strength, range of motion, and coordination of the masticatory and suprahyoid muscles.
The program is conducted 3 sessions per week for 4 weeks
|
A structured exercise program designed to enhance oral motor functions, including feeding efficiency, mouth opening range, and drooling
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Oral motor functions
Time Frame: Baseline and after 4 weeks of intervention
|
Assessment of oral motor skills including feeding, swallowing, and coordination using the Oral Motor Assessment Scale (OMAS).
The scale scores range from 0 to 2, where higher scores indicate better function
|
Baseline and after 4 weeks of intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mouth Opening Range
Time Frame: Baseline and after 4 weeks of intervention
|
Measurement of the maximum inter-incisal distance using tape measurement (measured in centimeters)
|
Baseline and after 4 weeks of intervention
|
|
Drooling Frequency and Severity
Time Frame: Baseline and after 4 weeks of intervention
|
Evaluation of drooling patterns using the Modified Drooling Questionnaire (MDQ).
Higher scores indicate more frequent and severe drooling.
|
Baseline and after 4 weeks of intervention
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Kamal Shoukry, PhD, Professor of Physical Therapy for Pediatrics, Faculty of Physical Therapy, Cairo University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.REC/012/006363
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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