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NCT Number: NCT06640686

The Effects of Inspiratory Muscle Training 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.

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

4 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise training

Other

Inspiratory muscle training for increase strength of inspiratory muscle.

Primary outcomes

  1. PP Check device

    Time frame: 6 months

    respiratory muscle strength will assess with device that called 'RP Check'.

  2. spirometer

    Time frame: 6 months

    respiratory function test will be assess with spirometer.

  3. trunk control mesurement scale

    Time frame: 6 months

    trunk control will assess with Trunk Control Measurement Scale.

  4. 10 m walking test

    Time frame: 6 months

    gait speed will assess with 10 meter walking test

  5. 2 minutes walking test

    Time frame: 6 months

    gait endurance will assess with 2 minutes walking test.

  6. WeeFIM scale

    Time frame: 6 months

    functional independence will assess with WeeFIM scale.

Study contacts

Contact information is provided by the study sponsor or research team.

Gamze Aydın, PhD

CONTACT

[email protected]

05377600256 ext. +90

Sponsors and collaborators

Lead sponsor

Istanbul University - Cerrahpasa

Other

Collaborators

  • Okan University

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 15, 2024
Registry last updated
Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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