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

Primary Purpose

Cerebral Palsy Spastic Diplegia

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Diaphragmatic exercises
conventional physiotherapy
Sponsored by
Uskudar University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy Spastic Diplegia focused on measuring cerebral palsy, respiratory strength, pulmonary functions, sitting ability

Eligibility Criteria

5 Years - 15 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Marmara University Pendik Training and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Research Group

Control Group

Arm Description

Diplegic Cerebral Palsy

Diplegic Cerebral Palsy

Outcomes

Primary Outcome Measures

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
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
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

Secondary Outcome Measures

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.
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.

Full Information

First Posted
September 26, 2022
Last Updated
March 14, 2023
Sponsor
Uskudar University
Collaborators
Marmara University
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1. Study Identification

Unique Protocol Identification Number
NCT05559346
Brief Title
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
January 8, 2022 (Actual)
Primary Completion Date
January 2, 2023 (Actual)
Study Completion Date
January 2, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Uskudar University
Collaborators
Marmara University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy Spastic Diplegia
Keywords
cerebral palsy, respiratory strength, pulmonary functions, sitting ability

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Research Group
Arm Type
Experimental
Arm Description
Diplegic Cerebral Palsy
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Diplegic Cerebral Palsy
Intervention Type
Other
Intervention Name(s)
Diaphragmatic exercises
Intervention Description
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
Intervention Name(s)
conventional physiotherapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Respiratory Muscle Strength Measurement (Maximum inspiratory pressure)
Description
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
Time Frame
8 weeks
Title
Respiratory Muscle Strength Measurement (Maximum Expiratory Pressure)
Description
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
Time Frame
8 weeks
Title
Thoracic Cage Mobility Assessment
Description
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
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Pulmonary Function Tests (PFT)
Description
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.
Time Frame
8 weeks
Title
Gross Motor Functional Measurement (Part B)
Description
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.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ozge Kenıs Coskun, PhD
Organizational Affiliation
Marmara University
Official's Role
Study Director
Facility Information:
Facility Name
Marmara University Pendik Training and Research Hospital
City
Istanbul
ZIP/Postal Code
34890
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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

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