Inspiratory Muscle Training in Children With Cerebral Palsy: Effects on Respiratory and Motor Functions

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.

Study Overview

• Status: Completed
• Conditions: Cerebral Palsy; Balance; Swallowing; Respiratory Function; Upper Extremity Function
• Intervention / Treatment: Other: Standard neurodevelopmental physiotherapy (SNP); Other: Inspiratory muscle training and standard neurodevelopmental physiotherapy (SNP)

Detailed Description

Cerebral palsy (CP) is a neurodevelopmental disorder characterised by permanent motor dysfunctions that develop in the prenatal, perinatal or postnatal period as a result of nonprogressive central nervous system involvement. CP involves not only the musculoskeletal system but also many different systems such as respiratory, digestive, sensory and cognitive systems, leading to a complex involvement. The complex involvement associated with the nature of CP necessitates a holistic and multidisciplinary approach in terms of treatment. In addition to common motor dysfunctions in the clinical picture, common comorbidities include epilepsy, swallowing disorders (dysphagia), gastrointestinal problems (e.g. constipation and reflux), nutritional deficiencies, behavioural problems, sensory disorders and respiratory system complications.

In individuals with CP, musculoskeletal system involvement results in significant comorbidities in the respiratory system. Especially weakness of respiratory muscles, inadequate airway clearance, increased risk of aspiration and recurrent respiratory tract infections are among the important complications reported in individuals with CP. This situation is more prominent especially for patients at levels IV and V according to the Gross Motor Function Classification System (GMFCS) and significantly negatively affects the quality of life of both the individual with CP and their caregivers.

Another important dysfunction in patients with CP is dysphagia, which develops mostly due to impaired motor control and coordination in the oral and pharyngeal phases. Oropharyngeal dysphagia (OPD) is quite common in children with CP and may lead to serious complications such as aspiration, malnutrition, growth retardation, gastroesophageal reflux disease and pneumonia. This effect, which can be seen in all phases of swallowing disorders, causes a decrease in muscle mass and immune functions by reducing energy intake, which increases susceptibility to infection.

In the field of pulmonary rehabilitation, individualised exercise programmes targeting respiratory muscles have recently attracted considerable attention, and studies using inspiratory muscle training (IMT) and feedback devices have provided significant improvements in maximum inspiratory and expiratory pressures. Studies have reported significant increases in daily living activities and quality of life of individuals after respiratory muscle training.

In line with the literature, the aim of this study was to investigate the effect of respiratory muscle training on respiratory muscle strength, respiratory and swallowing functions of individuals diagnosed with CP. In addition to the parameters mentioned in the study, the effectiveness of respiratory muscle training on trunk control and upper extremity functions in individuals with CP will also be questioned.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Istanbul, Turkey (Türkiye)
    • İstanbul Medipol University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control Group; 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); 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.
Experimental: Experimental Group; 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); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of upper extremity function	The AbilHand-Kids questionnaire will be used to assess participants' upper extremity function in daily life. The questionnaire is a 21-item survey that evaluates children's upper extremities bilaterally and assesses their ability to perform common tasks in daily living activities. The maximum score that can be obtained from the questionnaire is 42, and the minimum score is 0. A high score indicates that the individual uses their hand better in daily life compared to those with lower scores. An increase in the score indicates positive development, while a decrease in the score indicates negative development.	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 Pediatric Eating Assessment Tool-10 (PEDI-EAT-10) will be used to assess dysphagia. This 10-item scale is scored on a scale of 0-4 for each item. High scores on the scale are considered to indicate a risk of swallowing disorder or severe dysphagia symptoms.	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 Trunk Control Measurement Scale will be used to assess participants' trunk control. This scale assesses trunk control during functional activities. The scale contains a total of 15 items. The total score on the scale ranges from 0 to 58 points, with higher scores indicating better performance.	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	Patients will perform a rapid and complete inhalation maneuver from functional residual capacity to total lung capacity, followed by a continuous and maximal exhalation maneuver lasting at least six seconds. Verbal and non-verbal encouragement will be provided throughout the maneuvers. The test will be terminated once acceptable repeatability is achieved. The results will be recorded in litres.	The first assessment will be conducted during the first week. The final assessment will be conducted after the 8-week intervention.
Forced expiratory volume in one second (FEV1) assessment	Patients will perform a rapid and complete inhalation maneuver from functional residual capacity to total lung capacity, followed by a continuous and maximal exhalation maneuver lasting at least six seconds. Verbal and non-verbal encouragement will be provided throughout the maneuvers. The test will be terminated once acceptable repeatability is achieved. The results will be recorded in litres.	The first assessment will be conducted during the first week. The final assessment will be conducted after the 8-week intervention.
FEV1/FVC ratio	FVC and FEV1 results will be compared and expressed as percentages.	The first assessment will be conducted during the first week. The final assessment will be conducted after the 8-week intervention.
Forced expiratory flow 25-75% (FEF25-75) assessment	Patients will perform a rapid and complete inhalation maneuver from functional residual capacity to total lung capacity, followed by a continuous and maximal exhalation maneuver lasting at least six seconds. Verbal and non-verbal encouragement will be provided throughout the maneuvers. The test will be terminated once acceptable repeatability is achieved. The results will be expressed in litres per second.	The first assessment will be conducted during the first week. The final assessment will be conducted after the 8-week intervention.
Peak expiratory flow (PEF) assessment	Patients will perform a rapid and complete inhalation maneuver from functional residual capacity to total lung capacity, followed by a continuous and maximal exhalation maneuver lasting at least six seconds. Verbal and non-verbal encouragement will be provided throughout the maneuvers. The test will be terminated once acceptable repeatability is achieved. The results will be expressed in litres per minute.	The first assessment will be conducted during the first week. The final assessment will be conducted after the 8-week intervention.
Maximum expiratory pressure assessment	In the maximum expiratory pressure (MEP) measurement, subjects will first inhale and then exhale as hard as they can against the valve. The highest MEP value will be selected for use in the analyses.	The first assessment will be conducted during the first week. The final assessment will be conducted after the 8-week intervention.

Collaborators and Investigators

• Sponsor: Sadık Emre ÇELEBİ
• Collaborators: Okan University; Medipol University; Istanbul University - Cerrahpasa
• Investigators: Study Chair: Sadık Emre Çelebi, MSc, PhD(c), Physiotherapist, Istanbul University-Cerrahpaşa, Cardiology Institute, Department of Cardiology

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2025
• Primary Completion (Actual): December 20, 2025
• Study Completion (Actual): December 22, 2025

Study Registration Dates

• First Submitted: June 16, 2025
• First Submitted That Met QC Criteria: June 26, 2025
• First Posted (Actual): June 27, 2025

Study Record Updates

• Last Update Posted (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: breathing exercises; spirometry; cerebral palsy; postural balance; maximal respiratory pressures
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Brain Damage, Chronic; Pathological Conditions, Signs and Symptoms; Respiratory Aspiration; Cerebral Palsy
• Other Study ID Numbers: 10840098-202.3.02-2938

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No