The Effects of Inspiratory Muscle Training in Children With Cerebral Palsy

October 11, 2024 updated by: Gamze Aydin, Istanbul University - Cerrahpasa (IUC)

The Effects of Inspiratory Muscle Training on Respiratory Parameters, Trunk Control, Walking, and Functional Independence in Children With Cerebral Palsy

Cerebral palsy (CP) is characterized by permanent or variable sensory-motor function impairments resulting from developmental anomalies or damage to the brain. Spasticity, dystonia, postural disorders, and weakened movement patterns can hinder the development of the respiratory system in children with CP. As the severity of postural disorders increases in children with CP, inadequate or improper use of respiratory muscles and insufficient ventilation reduce the mobility of the thoracic cage. The aim of study is to investigate the effects of respiratory muscle training on respiratory parameters, trunk control, walking, and functional independence in children with CP.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

In this prospective randomized controlled study, participants will be divided into two groups: the Inspiratory Muscle Training (IMT) group and the control group. The IMT group will receive IMT in addition to the traditional physical therapy program, while the control group will only receive the traditional physical therapy program. Respiratory muscle strength, respiratory functions, chest expansion, trunk control, walking speed and endurance, and functional independence will be assessed before and after the training.

Study Type

Interventional

Enrollment (Estimated)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Aged between 4 and 12 years
  • Classified as levels 1, 2, and 3 according to the Gross Motor Function Classification System (GMFCS)
  • Diagnosed with spastic diplegia and/or hemiplegic cerebral palsy
  • Ability to cooperate during the exercises

Exclusion Criteria:

  • Presence of acute or chronic respiratory diseases
  • Presence of acute medical conditions
  • History of active epilepsy
  • Scoliosis with a Cobb angle greater than 30 degrees
  • Presence of chest deformities
  • Severe visual and hearing impairments

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Inspiratory Muscle Training Group
Inspiratory muscle training consists of strengthening exercise with threshold Inspiratory muscle training device.
Other: Exercise training
Inspiratory muscle training for increase strength of inspiratory muscle.
Active Comparator: Traditional Physiotherapy Group
The control group will receive the traditional physical therapy program.
Other: Exercise training
Inspiratory muscle training for increase strength of inspiratory muscle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PP Check device
Time Frame: 6 months
respiratory muscle strength will assess with device that called 'RP Check'.
6 months
spirometer
Time Frame: 6 months
respiratory function test will be assess with spirometer.
6 months
trunk control mesurement scale
Time Frame: 6 months
trunk control will assess with Trunk Control Measurement Scale.
6 months
10 m walking test
Time Frame: 6 months
gait speed will assess with 10 meter walking test
6 months
2 minutes walking test
Time Frame: 6 months
gait endurance will assess with 2 minutes walking test.
6 months
WeeFIM scale
Time Frame: 6 months
functional independence will assess with WeeFIM scale.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University - Cerrahpasa (IUC)

Collaborators

Okan University

Investigators

  • Principal Investigator: Gamze Aydın, PhD, Okan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 15, 2024

Primary Completion (Estimated)

March 15, 2025

Study Completion (Estimated)

April 15, 2025

Study Registration Dates

First Submitted

October 9, 2024

First Submitted That Met QC Criteria

October 11, 2024

First Posted (Actual)

October 15, 2024

Study Record Updates

Last Update Posted (Actual)

October 15, 2024

Last Update Submitted That Met QC Criteria

October 11, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IstanbulOkanUniv

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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