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

NCT05559346 | Completed

• 1 other identifier: CP1
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy Spastic Diplegia

Keywords

cerebral palsy; respiratory strength; pulmonary functions; sitting ability

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (2)

• Pulmonary Function Tests (PFT)

  8 weeks

• Gross Motor Functional Measurement (Part B)

  8 weeks

Study Arms (2)

Research Group

EXPERIMENTAL

Diplegic Cerebral Palsy

Other: Diaphragmatic exercises

Control Group

ACTIVE COMPARATOR

Diplegic Cerebral Palsy

Other: conventional physiotherapy

Interventions

Diaphragmatic exercises 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.

Research Group

conventional physiotherapy 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.

Control Group

Eligibility Criteria

• Age: 5 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Uskudar University: lead
• Marmara University: collaborator

Study Sites (1)

Marmara University Pendik Training and Research Hospital

Istanbul, 34890, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Ozge Kenıs Coskun, PhD

  Marmara University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: September 26, 2022
• First Posted: September 29, 2022
• Study Start: October 1, 2022
• Primary Completion: January 2, 2023
• Study Completion: January 2, 2023
• Last Updated: October 26, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)