跳至主要内容
临床试验/NCT07516860
NCT07516860进行中(未招募)不适用

Effect of Strain Counter Strain on Oromotor Functions in Children With Spastic Cerebral Palsy: A Randomized Controlled Trial

Cairo University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2026年1月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
30
试验地点
1
主要终点
Oral motor functions

研究概览

简要总结

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

详细描述

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

盲法说明

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.

入排标准

年龄范围
4 Years 至 8 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

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

干预措施: Strain Counter-Strain (SCS) (Procedure)

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

干预措施: Designed Oral Motor Program (Procedure)

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

干预措施: Designed Oral Motor Program (Procedure)

结局指标

主要结局

Oral motor functions

时间窗: 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

次要结局

  • Mouth Opening Range(Baseline and after 4 weeks of intervention)
  • Drooling Frequency and Severity(Baseline and after 4 weeks of intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Alshimaa Mohamed Mahmoud Hassan

Physical Therapist and Master Degree Candidate

Cairo University

研究点 (1)

Loading locations...

相似试验