The Effects of Inspiratory Muscle Training in Children With Cerebral Palsy

NCT06640686 | Not Yet Recruiting

• 1 other identifier: IstanbulOkanUniv
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Cerebral Palsy

Keywords

respiratory function test; muscle strength; gait; trunk

Outcome Measures

Primary Outcomes (6)

• PP Check device

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

  6 months

• spirometer

  respiratory function test will be assess with spirometer.

  6 months

• trunk control mesurement scale

  trunk control will assess with Trunk Control Measurement Scale.

  6 months

• 10 m walking test

  gait speed will assess with 10 meter walking test

  6 months

• 2 minutes walking test

  gait endurance will assess with 2 minutes walking test.

  6 months

• WeeFIM scale

  functional independence will assess with WeeFIM scale.

  6 months

Study Arms (2)

Inspiratory Muscle Training Group

EXPERIMENTAL

Inspiratory muscle training consists of strengthening exercise with threshold Inspiratory muscle training device.

Other: Exercise training

Traditional Physiotherapy Group

ACTIVE COMPARATOR

The control group will receive the traditional physical therapy program.

Other: Exercise training

Interventions

Exercise training OTHER

Inspiratory muscle training for increase strength of inspiratory muscle.

Inspiratory Muscle Training Group; Traditional Physiotherapy Group

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead
• Okan University: collaborator

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Gamze Aydın, PhD

  Okan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gamze Aydın, PhD

CONTACT

05377600256; gamze.tosun@okan.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants will be blind to their group and outcomes assessor will be blind to groups.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: randomized controlled study

Study Record Dates

• First Submitted: October 9, 2024
• First Posted: October 15, 2024
• Study Start: November 15, 2024
• Primary Completion: March 15, 2025
• Study Completion: April 15, 2025
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share