Effects of Inspiratory Muscle Training on Respiratory Parameters, Trunk Control, Upper Extremity Function and Swallowing in Children With Cerebral Palsy: A Randomized Controlled Trial

NCT07041593 | Completed DMC

• 1 other identifier: 10840098-202.3.02-2938
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study investigates the effect of inspiratory muscle training on respiratory parameters, trunk control, upper extremity function and swallowing in patients with cerebral palsy aged 5-18 years. The results of the study aim to provide a clinical perspective for clinicians working with patients diagnosed with cerebral palsy between the ages of 5-18 years and to contribute to the literature.

Conditions

Cerebral Palsy; Respiratory Function; Balance; Swallowing; Upper Extremity Function

Keywords

breathing exercises; cerebral palsy; maximal respiratory pressures; postural balance; spirometry

Outcome Measures

Primary Outcomes (1)

• Maximum inspiratory pressure assessment

  For the measurement of maximum inspiratory pressure (MIP), participants will be asked to first exhale against a valve that closes the airway, and then perform maximum inspiration. The highest MIP value will be selected for use in analyses.

  The first assessment will be conducted during the first week. The final assessment will be conducted after the 8-week intervention.

Secondary Outcomes (9)

• Maximum expiratory pressure assessment

  The first assessment will be conducted during the first week. The final assessment will be conducted after the 8-week intervention.

• Assessment of upper extremity function

  The first assessment will be conducted during the first week. The final assessment will be conducted after the 8-week intervention.

• Assessment of swallowing

  The first assessment will be conducted during the first week. The final assessment will be conducted after the 8-week intervention.

• Assessment of trunk control

  The first assessment will be conducted during the first week. The final assessment will be conducted after the 8-week intervention.

• Forced vital capacity (FVC) massessment

  The first assessment will be conducted during the first week. The final assessment will be conducted after the 8-week intervention.

Study Arms (2)

Control Group

ACTIVE COMPARATOR

Participants in the control group will undergo a standard neurodevelopmental physiotherapy (SNP) for 8 weeks, consisting of two 40-minute sessions per week under the supervision of a physiotherapist.

Other: Standard neurodevelopmental physiotherapy (SNP)

Experimental Group

EXPERIMENTAL

Inspiratory muscle training (IMT) in addition to the standard neurodevelopmental physiotherapy (SNP) program. The initial training load was set at 30% of MIP. MIP was remeasured weekly, and the training load was updated according to 30% of the newly obtained value. Resistance adjustments were performed weekly by the physiotherapist. The IMT program was performed for eight weeks, five days per week, in two 15-minute sessions per day, for a total of 30 minutes daily. Two sessions per week were supervised by a physiotherapist, while the remaining sessions were performed as a home-based program. Participants were asked to record their home exercise sessions in a weekly follow-up form prepared by the researchers and to bring the form to the first session of each week for compliance monitoring.

Other: Inspiratory muscle training and standard neurodevelopmental physiotherapy (SNP)

Interventions

Inspiratory muscle training and standard neurodevelopmental physiotherapy (SNP) OTHER

Inspiratory muscle training (IMT) in addition to the standard neurodevelopmental physiotherapy (SNP) program. The initial training load was set at 30% of MIP. MIP was remeasured weekly, and the training load was updated according to 30% of the newly obtained value. Resistance adjustments were performed weekly by the physiotherapist. The IMT program was performed for eight weeks, five days per week, in two 15-minute sessions per day, for a total of 30 minutes daily. Two sessions per week were supervised by a physiotherapist, while the remaining sessions were performed as a home-based program. Participants were asked to record their home exercise sessions in a weekly follow-up form prepared by the researchers and to bring the form to the first session of each week for compliance monitoring.

Experimental Group

Standard neurodevelopmental physiotherapy (SNP) OTHER

Participants in the control group will undergo a standard neurodevelopmental physiotherapy (SNP) for 8 weeks, consisting of two 40-minute sessions per week under the supervision of a physiotherapist.

Control Group

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Participants aged 5-18 years
• Diagnosed with cerebral palsy (CP) by a paediatric neurologist
• Classified as Gross Motor Function Classification System (GMFCS) levels I-II
• Possessing communication skills sufficient to understand verbal or written language and follow assessment and intervention instructions

You may not qualify if:

• History of lung infection within the previous month
• Haemodynamic instability (heart rate \>150 beats/min, systolic blood pressure \>140 mmHg, or diastolic blood pressure \>90 mmHg)
• Orthopaedic surgery or botulinum toxin injection within the previous six months
• Severe chest infection or an active respiratory condition that could limit participation in the study
• Mental or auditory dysfunction that could interfere with participation in the assessment or intervention procedures

Sponsors & Collaborators

• Okan University: collaborator
• Istanbul University - Cerrahpasa: collaborator
• Medipol University: collaborator
• Sadık Emre ÇELEBİ: lead

Study Sites (1)

Istanbul Medipol University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cerebral Palsy; Respiratory Aspiration

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sadık Emre Çelebi, MSc, PhD(c), Physiotherapist

  Istanbul University-Cerrahpaşa, Cardiology Institute, Department of Cardiology

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MSc, PhD(c), Physiotherapist

Study Record Dates

• First Submitted: June 16, 2025
• First Posted: June 27, 2025
• Study Start: May 15, 2025
• Primary Completion: December 20, 2025
• Study Completion: December 22, 2025
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

TU (1)