The Effects of Inspiratory Muscle Training in Children With Cerebral Palsy

NCT ID: NCT06640686

Last Updated: 2024-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-15

Study Completion Date

2025-04-15

Brief Summary

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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

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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.

Conditions

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Cerebral Palsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized controlled study
Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Participants will be blind to their group and outcomes assessor will be blind to groups.

Study Groups

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Inspiratory Muscle Training Group

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

Group Type EXPERIMENTAL

Exercise training

Intervention Type OTHER

Inspiratory muscle training for increase strength of inspiratory muscle.

Traditional Physiotherapy Group

The control group will receive the traditional physical therapy program.

Group Type ACTIVE_COMPARATOR

Exercise training

Intervention Type OTHER

Inspiratory muscle training for increase strength of inspiratory muscle.

Interventions

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Exercise training

Inspiratory muscle training for increase strength of inspiratory muscle.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

4 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Okan University

OTHER

Sponsor Role collaborator

Istanbul University - Cerrahpasa

OTHER

Sponsor Role lead

Responsible Party

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Gamze Aydin

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gamze Aydın, PhD

Role: PRINCIPAL_INVESTIGATOR

Okan University

Central Contacts

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Gamze Aydın, PhD

Role: CONTACT

05377600256 ext. +90

Other Identifiers

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IstanbulOkanUniv

Identifier Type: -

Identifier Source: org_study_id

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