NCT07516860

Brief Summary

This study evaluates the clinical efficacy of the Strain Counter-Strain (SCS) technique on improving oromotor functions in children with spastic cerebral palsy. The intervention specifically targets the masseter, SCM, upper trapezius, scalenes, and suprahyoid muscles to release myofascial tension. The study aims to determine if modulating muscle tone through SCS can provide a stable postural foundation to enhance functional oral motor skills. Outcomes are measured after 4 weeks (one month) of intervention, focusing on mouth opening range, drooling frequency and severity, and overall oral motor functions

Trial Health

55
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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 20, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 1, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 8, 2026

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2026

Completed
Last Updated

April 14, 2026

Status Verified

April 1, 2026

Enrollment Period

3 months

First QC Date

April 1, 2026

Last Update Submit

April 9, 2026

Conditions

Keywords

Strain Counter-StrainSCS techniqueOromotor FunctionsMouth OpeningDrooling SeverityMasseter MusclePediatric Physical TherapySpastic cerebral palsy

Outcome Measures

Primary Outcomes (1)

  • Oral motor functions

    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

Secondary Outcomes (2)

  • Mouth Opening Range

    Baseline and after 4 weeks of intervention

  • Drooling Frequency and Severity

    Baseline and after 4 weeks of intervention

Study Arms (2)

Strain counter-strain plus oral motor program

EXPERIMENTAL

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

Procedure: Strain Counter-Strain (SCS)Procedure: Designed Oral Motor Program

Oral motor program only

ACTIVE COMPARATOR

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

Procedure: Designed Oral Motor Program

Interventions

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

Strain counter-strain plus oral motor program

A structured exercise program designed to enhance oral motor functions, including feeding efficiency, mouth opening range, and drooling

Oral motor program onlyStrain counter-strain plus oral motor program

Eligibility Criteria

Age4 Years - 8 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physical Therapy, Cairo University

Giza, Egypt

Location

MeSH Terms

Conditions

SialorrheaCerebral Palsy

Condition Hierarchy (Ancestors)

Salivary Gland DiseasesMouth DiseasesStomatognathic DiseasesBrain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Kamal Shoukry, PhD

    Professor of Physical Therapy for Pediatrics, Faculty of Physical Therapy, Cairo University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
This is an open-label study where both the participants and the investigator are aware of the assigned interventions. Masking was not feasible due to the nature of the manual therapy technique (Strain Counter-Strain) and the active involvement of the physical therapist in administering the protocol.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This is a two-arm, randomized controlled trial with a parallel assignment design. Participants are randomly allocated into two groups: the Study Group and the Control Group. Both groups receive the intervention concurrently over a period of 4 weeks. The Study Group receives the Strain Counter-Strain (SCS) technique followed by a designed oral motor program, while the Control Group receives the designed oral motor program alone. Outcomes are assessed for both groups at baseline and immediately following the 4-week intervention period.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physical Therapist and Master Degree Candidate

Study Record Dates

First Submitted

April 1, 2026

First Posted

April 8, 2026

Study Start

January 20, 2026

Primary Completion

April 15, 2026

Study Completion

May 30, 2026

Last Updated

April 14, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be available to protect the privacy and confidentiality of the participants. The study results will be disseminated through the final thesis and potential peer-reviewed publications as aggregate data only

Locations