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

NCT ID: NCT05559346

Last Updated: 2023-10-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-01
• Study Completion Date: 2023-01-02

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.

Conditions

Cerebral Palsy Spastic Diplegia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Research Group

Diplegic Cerebral Palsy

Group Type: EXPERIMENTAL

Diaphragmatic exercises

Intervention Type: OTHER

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.

Control Group

Diplegic Cerebral Palsy

Group Type: ACTIVE_COMPARATOR

conventional physiotherapy

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Marmara University

OTHER

Sponsor Role: collaborator

Uskudar University

OTHER

Sponsor Role: lead

Responsible Party

Berna Karamancıoğlu

Research Assistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ozge Kenıs Coskun, PhD

Role: STUDY_DIRECTOR

Marmara University

Locations

Marmara University Pendik Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

CP1

Identifier Type: -

Identifier Source: org_study_id