Expiratory Muscle Training in Children With Cerebral Palsy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-30

Study Completion Date

2026-03-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Cerebral Palsy (CP)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This randomized controlled trial consists of two parallel groups and is designed to compare the effects of expiratory muscle training with those of sham expiratory muscle training in children with spastic-type cerebral palsy.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Expiratory Muscle Training

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.

Group Type EXPERIMENTAL

Expiratory Muscle Training

Intervention Type BEHAVIORAL

In the expiratory muscle training group, participants will receive a respiratory exercise program consisting of breathing control, diaphragmatic breathing, and thoracic expansion exercises. In addition, expiratory muscle training (EMT) will be performed using the POWERbreathe EX1 device at 50% of each participant's measured maximal expiratory pressure (MEP).

Participants will be instructed to perform 25 repetitions per session, structured as 5 cycles of 5 breaths with 1-minute rest intervals between each cycle. The training will be performed daily at home for a duration of 8 weeks. Compliance will be monitored through exercise tracking forms.

To ensure progressive loading, MEP will be reassessed every 10 days, and the resistance of the device will be adjusted accordingly. Participants will be invited for in-person interim evaluations at these 10-day intervals to update their training parameters.

Sham Expiratory Muscle Training

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.

Group Type SHAM_COMPARATOR

Sham Expiratory Muscle Training

Intervention Type BEHAVIORAL

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.

Interventions

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Expiratory Muscle Training

In the expiratory muscle training group, participants will receive a respiratory exercise program consisting of breathing control, diaphragmatic breathing, and thoracic expansion exercises. In addition, expiratory muscle training (EMT) will be performed using the POWERbreathe EX1 device at 50% of each participant's measured maximal expiratory pressure (MEP).

Participants will be instructed to perform 25 repetitions per session, structured as 5 cycles of 5 breaths with 1-minute rest intervals between each cycle. The training will be performed daily at home for a duration of 8 weeks. Compliance will be monitored through exercise tracking forms.

To ensure progressive loading, MEP will be reassessed every 10 days, and the resistance of the device will be adjusted accordingly. Participants will be invited for in-person interim evaluations at these 10-day intervals to update their training parameters.

Intervention Type BEHAVIORAL

Sham Expiratory Muscle Training

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

12 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No