Cerebral Palsy (CP)
Conditions
Keywords
cerebral palsy, expiratory muscle training, trunk control, posture, balance, respiratory rehabilitation
Brief summary
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.
Interventions
BEHAVIORALExpiratory 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.
BEHAVIORALSham 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.
Sponsors
Istinye University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
12 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Selective Motor Control Assessment (SCALE), (Noraxon MyoMotion) | 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. |
| Respiratory Muscle Strength Assessment (MIP/MEP) | Before treatment, week 8 | — |
| Peak Cough Flow | before treatment, week 8 | — |
| Assessment of Posture (PostureScreen App) | before treatment, week 8 | — |
| Trunk Control Assessment (ProKin Star Excursion Balance Test, Trunk Control Measurement Scale (TCMS)) | 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®) | before treatmant, week 8 | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Communication Function Classification System (CFCS) | before treatment | The Communication Function Classification System (CFCS) is a five-level classification system used to describe everyday communication performance in individuals with cerebral palsy. Levels range from I (most effective communicator) to V (least effective communicator). Lower levels indicate more effective and independent communication abilities. |
| Gross Motor Function Classification System (GMFCS) | before treatment | The Gross Motor Function Classification System (GMFCS) is a five-level system used to classify gross motor function in children with cerebral palsy. Levels range from I (most independent) to V (most limited). Lower levels represent better motor function and greater independence in mobility. |
| Muscle Tone Evaluation (Modified Ashworth Scale (MAS)) | before treatment | Muscle tone will be assessed using the Modified Ashworth Scale (MAS), a widely used clinical tool for measuring spasticity. The scale ranges from 0 to 4, with an additional score of 1+ to indicate slight increases in muscle tone. A score of 0 indicates no increase in muscle tone, while a score of 4 indicates a rigid limb in flexion or extension. Higher scores reflect greater spasticity. |
| Gross Motor Function Measure (GMFM) | before treatment, week 8 | Gross motor function will be evaluated using selected sections of the Gross Motor Function Measure (GMFM-88), a standardized observational tool developed to assess changes in motor function in children with cerebral palsy. In this study, only dimensions D (Standing) and E (Walking, Running, and Jumping) will be administered. Each item is scored on a 4-point ordinal scale from 0 (does not initiate) to 3 (completes the activity). Scores will be expressed as a percentage of the maximum possible score for the selected dimensions, with higher percentages indicating better gross motor performance. |
| Modified Functional Reach Test (MFRT) | before treatment, week 8 | Dynamic balance will be assessed using the Modified Functional Reach Test (MFRT), which evaluates the maximum distance an individual can reach forward and laterally while maintaining a fixed base of support in a seated position. The test is performed in three directions: forward, right, and left. The distance is measured in centimeters. Higher reach distances indicate better dynamic sitting balance and trunk stability. |
| Prone Plank Test | before treatment, week 8 | Core endurance will be assessed using the Prone Plank Test, which measures the amount of time an individual can maintain a prone plank position (forearms and toes supporting the body, body in a straight line) without losing form. The test is performed on a flat surface, and time is recorded in seconds. A longer duration indicates greater core muscle endurance. |
Contacts
Primary ContactZeynep KAVRIK
Outcome results
None listed