Investigation of the Effects of Diaphragm Exercises in Children With Cerebral Palsy

Cerebral Palsy Spastic Diplegia Clinical Trial

Official title:

Investigation of the Effects of Diaphragm Exercises in Children With Cerebral Palsy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05559346
• Other study ID #: CP1
• Status: Completed
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: January 2, 2023

Study information

• Verified date: October 2023
• Source: Uskudar University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: January 2, 2023
• Est. primary completion date: January 2, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy
• Cerebral Palsy Spastic Diplegia
• Paralysis

Intervention

Other:
• Diaphragmatic exercises
Diaphragm exercises will be applied to the research group in addition to conventional rehabilitation.The content of the individualized conventional rehabilitation program consists of passive stretching exercises, strengthening exercises to antagonists of spastic muscles and exercises aimed at improving weight transfer, balance and correction reactions, and postural control. 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.
• conventional physiotherapy
The control group will only be taken to the conventional rehabilitation program. e content of the individualized conventional rehabilitation program consists of passive stretching exercises, strengthening exercises to antagonists of spastic muscles and exercises aimed at improving weight transfer, balance and correction reactions, and postural control.

Locations

Country	Name	City	State
Turkey	Marmara University Pendik Training and Research Hospital	Istanbul

Sponsors (2)

Lead Sponsor	Collaborator
Uskudar University	Marmara University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Respiratory Muscle Strength Measurement (Maximum inspiratory pressure)	It will be used as the primary outcome measure in the study. In our study, respiratory muscle strength will be measured with a portable intraoral pressure measuring device (MicroRPM) Maximum static inspiratory pressure (MIP) will be measured at residual volume after maximum expiration. Measurements will be made twice in a sitting position with verbal encouragement and using a nose clip. The highest value obtained, with no more than 10% or 10cmH2O difference between the two measured values, will be used for analysis	8 weeks
Primary	Respiratory Muscle Strength Measurement (Maximum Expiratory Pressure)	It will be used as the primary outcome measure in the study. In our study, respiratory muscle strength will be measured with a portable intraoral pressure measuring device (MicroRPM) Maximum static expiratory pressure (MEP) will be measured at maximum post-inspiratory total lung capacity.; Measurements will be made twice in a sitting position with verbal encouragement and using a nose clip. The highest value obtained, with no more than 10% or 10 cmH2O difference between the two measured values, will be used for analysis	8 weeks
Primary	Thoracic Cage Mobility Assessment	Chest circumference measurements will be used to determine respiratory type. Measurements will be recorded in centimeters, using a tape measure, in an upright sitting position, from the axillary, epigastric and subcostal regions, the difference between neutral, deep inspiration and deep expiration	8 weeks
Secondary	Pulmonary Function Tests (PFT)	Pulmonary function tests will be performed with a spirometer device in the evaluation of pulmonary capacity. Pulmonary function tests are maneuvers applied to measure lung functions using standard devices. In this thesis, forced vital capacity (FVC), forced vital volume in one second (FEV1), FEV1/FVC and peak expiratory flow (PEF) values will be examined with pulmonary function tests.	8 weeks
Secondary	Gross Motor Functional Measurement (Part B)	Sitting skill will be evaluated with the sub-section B of the Gross Motor Function Measure (GMFM) test. Sitting, which is part B, consists of 20 items. The gross motor functions in these items are evaluated according to the degree of achievement of the function. Scoring is done on a Likert scale between 0 and 3 points. A score of 0 indicates that the activity could not be started at all, and 3 indicates that 90-100% of it can be done.	8 weeks