Expiratory Muscle Training in Children With Cerebral Palsy (CP-EMT)

Istinye University

Status: Not yet enrolling

Conditions: Cerebral Palsy (CP)

Treatments: Behavioral: Expiratory Muscle Training; Behavioral: Sham Expiratory Muscle Training

Study type: Interventional

Funder types: Other

Identifiers

NCT07048223

IstinyeUni-Z.KAVRIK.001

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 12 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

20 participants in 2 patient groups

Expiratory Muscle Training

Experimental group

Description:

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.

Treatment:

Behavioral: Expiratory Muscle Training

Sham Expiratory Muscle Training

Sham Comparator group

Description:

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.

Treatment:

Behavioral: Sham Expiratory Muscle Training