Clinical trial NCT05559346: Investigation of the Effects of Diaphragm Exercises in Children With Cerebral Palsy
Official title: Investigation of the Effects of Diaphragm Exercises in Children With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy Spastic Diplegia
Keywords: cerebral palsy
respiratory strength
pulmonary functions
sitting ability
Lead sponsor: Uskudar University
Sponsor class: OTHER
Collaborators: name: Marmara University
First posted: 2022-09-29
Enrollment: 15
Sex: ALL
Minimum age (years): 5
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to examine the effects of diaphragmatic myofascial relaxation exercise and diaphragmatic breathing exercises added to the conventional physiotherapy and rehabilitation program in children with diplegic cerebral palsy (CP), primarily on MIP, MEP, and secondarily on thoracic cage mobility, pulmonary functions and sitting ability.

Detailed description: This research is a randomized controlled trial. Volunteers diagnosed with cerebral palsy who applied to Marmara University Pendik Training and Research Hospital will participate in the research. A voluntary consent form will be obtained from the participants at the beginning of the study. Demographic and clinical information form will be filled for each patient at the beginning of the study before clinical evaluations. Demographic and clinical information form; Age, gender, height, weight, body mass index (BMI), how many weeks were born, birth weight, drug use, disease history, number of siblings, neonatal intensive care hospitalization history, education level of parents will be questioned. The Gross Motor Functional Classification System (KMFSS) will be used to determine the functionality levels of the volunteers who will participate in the study. The following tests will be applied to all of the volunteers who will participate in our study before and after the intervention:

Respiratory Muscle Strength Measurement Thoracic Cage Mobility Assessment Pulmonary Function Tests Gross Motor Functional Measurement (part B) Children meeting the inclusion criteria will be randomly assigned to two groups. The control and research groups will receive an individualized conventional rehabilitation program for 45 minutes, 2 days a week for 8 weeks. In addition to conventional rehabilitation, manual diaphragmatic relaxation exercises and diaphragmatic breathing exercises will be applied to the children in the research group two days a week.

After 8 weeks of intervention and control group applications, the evaluations made at the beginning of the intervention will be repeated. The evaluations of the two groups will be compared statistically and the results will be interpreted.

Eligibility criteria: Inclusion Criteria:

* Being diagnosed with spastic diplegic cerebral palsy
* Being between the ages of 5-15
* Gross Motor Functional Classification System 1,2 or 3
* To be at a cognitive level to be able to understand and apply the instructions in the tests (SFT, MIP, MEP) to be applied

Exclusion Criteria:

* Having had a surgical operation in the last 6 months
* Presence of scoliosis detected above 30 degrees
* Having a planned surgery within 3 months from the start of the study
* Have a chronic lung disease

Primary outcomes:
measure: Respiratory Muscle Strength Measurement (Maximum inspiratory pressure)
timeFrame: 8 weeks
measure: Respiratory Muscle Strength Measurement (Maximum Expiratory Pressure)
timeFrame: 8 weeks
measure: Thoracic Cage Mobility Assessment
timeFrame: 8 weeks
Secondary outcomes:
measure: Pulmonary Function Tests (PFT)
timeFrame: 8 weeks
measure: Gross Motor Functional Measurement (Part B)
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara University Pendik Training and Research Hospital
Study officials:
affiliation: Marmara University
name: Ozge Kenıs Coskun, PhD
role: STUDY_DIRECTOR
References: