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临床试验/NCT07048223
NCT07048223尚未招募不适用

Effects of Expiratory Muscle Training on Posture, Balance, Trunk Control, and Respiratory Function in Children With Cerebral Palsy

Istinye University0 个研究点目标入组 20 人开始时间: 2025年7月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
20
主要终点
Peak Cough Flow

研究概览

简要总结

This study aims to examine the effects of expiratory muscle training on posture, trunk control, balance, selective motor control, and respiratory function in children with spastic-type cerebral palsy (CP). The research focuses on evaluating an innovative rehabilitation approach that addresses common challenges observed in children with CP, such as trunk instability, reduced respiratory capacity, and postural abnormalities.

In individuals with CP, the ineffective use of respiratory muscles affects not only the respiratory system but also trunk control and overall motor performance. While most existing studies emphasize inspiratory muscle training, research on expiratory muscle training remains limited. Therefore, this study seeks to fill this gap by investigating the neuromotor effects of expiratory muscle training-an emerging component of respiratory rehabilitation-in children with CP.

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
Single (Outcomes Assessor)

入排标准

年龄范围
12 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Diagnosis of cerebral palsy
  • •Age between 12 and 18 years
  • •Gross Motor Function Classification System (GMFCS) Level I or II
  • •Communication Function Classification System (CFCS) Level I, II, or III
  • •Spasticity graded as 0, 1, 1+, or 2 on the Modified Ashworth Scale
  • •No history of Botulinum Toxin-A injection or orthopedic surgery within the past 6 months

排除标准

  • •Spasticity graded as 3 or 4 on the Modified Ashworth Scale Uncontrolled seizures
  • •Presence of congenital cardiopulmonary disease, autism spectrum disorder, balance-impairing conditions, or significant visual/hearing impairments
  • •Acute respiratory tract infection

研究组 & 干预措施

Expiratory Muscle Training

Experimental

In this group, expiratory muscle training will be administered using the POWERbreathe EX1 device, set at 50% of each participant's measured maximal expiratory pressure (MEP). Participants will be instructed to perform the exercises daily at home for a duration of 8 weeks. Interim assessments will be conducted every 10 days. Exercise compliance will be monitored using daily exercise tracking forms.

干预措施: Expiratory Muscle Training (Behavioral)

Sham Expiratory Muscle Training

Sham Comparator

In the sham expiratory muscle training group, participants will perform a respiratory exercise program including breathing control, diaphragmatic breathing, and thoracic expansion exercises. In addition, sham expiratory muscle training will be administered using the POWERbreathe EX1 device set at 10% of the participant's measured maximal expiratory pressure (MEP), providing minimal resistance.

Participants will be instructed to perform the exercises daily at home for a period of 8 weeks. Compliance will be monitored through exercise tracking forms. No progressive loading or resistance adjustments will be made during the intervention period.

干预措施: Sham Expiratory Muscle Training (Behavioral)

结局指标

主要结局

Peak Cough Flow

时间窗: before treatment, week 8

Trunk Control Assessment (ProKin Star Excursion Balance Test, Trunk Control Measurement Scale (TCMS))

时间窗: Before treatment, week 8

Trunk control will be assessed using the Trunk Control Measurement Scale (TCMS) and the ProKin Star Excursion Balance Test. The TCMS evaluates static and dynamic trunk control in children with cerebral palsy. Scores range from 0 to 58, with higher scores indicating better trunk control. The ProKin Star Excursion Balance Test measures postural stability and trunk coordination using a computerized force platform. Assessments will be conducted before treatment and at the end of the 8th week.

Balance Assessment (PROKIN®)

时间窗: before treatmant, week 8

Respiratory Muscle Strength Assessment (MIP/MEP)

时间窗: Before treatment, week 8

Peak Cough Flow

时间窗: before treatment, week 8

Trunk Control Assessment (ProKin Star Excursion Balance Test, Trunk Control Measurement Scale (TCMS))

时间窗: Before treatment, week 8

Trunk control will be assessed using the Trunk Control Measurement Scale (TCMS) and the ProKin Star Excursion Balance Test. The TCMS evaluates static and dynamic trunk control in children with cerebral palsy. Scores range from 0 to 58, with higher scores indicating better trunk control. The ProKin Star Excursion Balance Test measures postural stability and trunk coordination using a computerized force platform. Assessments will be conducted before treatment and at the end of the 8th week.

Assessment of Posture (PostureScreen App)

时间窗: before treatment, week 8

Balance Assessment (PROKIN®)

时间窗: before treatmant, week 8

Selective Motor Control Assessment (SCALE), (Noraxon MyoMotion)

时间窗: before treatment, week 8

Selective motor control will be assessed using the Selective Control Assessment of the Lower Extremity (SCALE). The SCALE evaluates the ability to perform isolated joint movements in the lower limbs and is scored bilaterally. Each limb can score from 0 to 10 points, with a total possible score ranging from 0 to 20. Higher scores indicate better selective voluntary motor control. Additionally, Noraxon MyoMotion will be used to collect objective kinematic data to support the SCALE assessment.

次要结局

  • Communication Function Classification System (CFCS)(before treatment)
  • Gross Motor Function Classification System (GMFCS)(before treatment)
  • Muscle Tone Evaluation (Modified Ashworth Scale (MAS))(before treatment)
  • Communication Function Classification System (CFCS)(before treatment)
  • Gross Motor Function Classification System (GMFCS)(before treatment)
  • Muscle Tone Evaluation (Modified Ashworth Scale (MAS))(before treatment)
  • Gross Motor Function Measure (GMFM)(before treatment, week 8)
  • Modified Functional Reach Test (MFRT)(before treatment, week 8)
  • Prone Plank Test(before treatment, week 8)

研究者

申办方类型
Other
责任方
Sponsor

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