SialorrheaNCT07516860
Effect of SCS Technique on Oromotor Skills in Children With CP
A study testing Strain Counter-Strain (SCS) and Designed Oral Motor Program in people with Sialorrhea and Spastic Cerebral Palsy (sCP), run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 8 years
- Conditions the study is for
- Sialorrhea, Spastic Cerebral Palsy (sCP), Strain Counterstrain Technique
- What is being tested?
- Strain Counter-Strain (SCS) and Designed Oral Motor Program
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Jan 2026to 30 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Strain Counter Strain on Oromotor Functions in Children With Spastic Cerebral Palsy: A Randomized Controlled Trial
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
Read the 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
- Conditions
- Sialorrhea, Spastic Cerebral Palsy (sCP), Strain Counterstrain Technique, Oral Motor Functions, Mouth Opening
- Being tested
- Strain Counter-Strain (SCS), Designed Oral Motor Program
- Keywords
- Strain Counter-Strain, SCS technique, Oromotor Functions, Mouth Opening, Drooling Severity, Masseter Muscle, Pediatric Physical Therapy, Spastic cerebral palsy
- Medical subject headings
- Sialorrhea, Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strain Counter-Strain (SCS)Procedure or surgery
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
Designed Oral Motor ProgramProcedure or surgery
A structured exercise program designed to enhance oral motor functions, including feeding efficiency, mouth opening range, and drooling
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Procedure: Designed Oral Motor Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline and after 4 weeks of intervention
Secondary outcomes (2)
Mouth Opening Range
Measurement of the maximum inter-incisal distance using tape measurement (measured in centimeters)
Measured: Baseline and after 4 weeks of intervention
Drooling Frequency and Severity
Evaluation of drooling patterns using the Modified Drooling Questionnaire (MDQ). Higher scores indicate more frequent and severe drooling.
Measured: Baseline and after 4 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2026
- Study start20 Jan 2026
- Primary completion15 Apr 2026 (estimated)
- Study completion30 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SialorrheaStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alshimaa Mohamed Mahmoud Hassan, Cairo University
- Investigators
- Kamal Shoukry, PhD, Study director, Professor of Physical Therapy for Pediatrics, Faculty of Physical Therapy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07516860
- Sponsor's protocol ID
- P.T.REC/012/006363
- Status last verified
- Apr 2026
- First submitted
- 1 Apr 2026
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Strain Counter Strain on Oromotor Functions in Children With Spastic Cerebral Palsy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07516860
- Acronym / sponsor ID
- P.T.REC/012/006363
- Conditions
- Sialorrhea, Spastic Cerebral Palsy (sCP), Strain Counterstrain Technique, Oral Motor Functions, Mouth Opening
- Keywords
- Strain Counter-Strain, SCS technique, Oromotor Functions, Mouth Opening, Drooling Severity, Masseter Muscle, Pediatric Physical Therapy, Spastic cerebral palsy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Jan 2026 (actual)
- Primary completion
- 15 Apr 2026 (estimated)
- Study completion
- 30 May 2026 (estimated)
- First posted
- 8 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Strain counter-strain plus oral motor program | Experimental | Procedure: Strain Counter-Strain (SCS), Procedure: Designed Oral Motor ProgramThis 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 |
| Oral motor program only | Active comparator | Procedure: Designed Oral Motor ProgramThis 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 |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Strain Counter-Strain (SCS)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 | Procedure or surgery | Strain counter-strain plus oral motor program |
| Designed Oral Motor ProgramA structured exercise program designed to enhance oral motor functions, including feeding efficiency, mouth opening range, and drooling | Procedure or surgery | Oral motor program only, Strain counter-strain plus oral motor program |
Primary outcome
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
2 secondary outcomes
Mouth Opening Range
Time frame: Baseline and after 4 weeks of intervention
Drooling Frequency and Severity
Time frame: Baseline and after 4 weeks of intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Individual participant dataSharing planned: No. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kamal Shoukry, PhD study director
Professor of Physical Therapy for Pediatrics, Faculty of Physical Therapy, Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strain Counter-Strain (SCS) and Designed Oral Motor Program in people with Sialorrhea and Spastic Cerebral Palsy (sCP), run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oral motor functions (time frame: Baseline and after 4 weeks of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.