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Not yet recruiting NCT06640686

The Effects of Inspiratory Muscle Training in Children With Cerebral Palsy

No phase Interventional Cerebral Palsy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Exercise training.
Who it may be relevant to
Registry conditions: Cerebral Palsy. Basic parameters: 4 years — 12 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

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.

Interventions

  • Other Exercise training
    Inspiratory muscle training for increase strength of inspiratory muscle.

Primary outcome measures

  • PP Check device [Time frame: 6 months]
  • spirometer [Time frame: 6 months]
  • trunk control mesurement scale [Time frame: 6 months]
  • 10 m walking test [Time frame: 6 months]
  • 2 minutes walking test [Time frame: 6 months]
  • WeeFIM scale [Time frame: 6 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Prevention

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06640686 · IstanbulOkanUniv

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗