The Effect of Inspiratory Muscle Training on Functional Gain in Cerebral Palsy: A Randomised Controlled Trial

NCT ID: NCT07041593

Last Updated: 2026-01-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-15
• Study Completion Date: 2025-12-22

Brief Summary

This study investigates the effect of respiratory muscle training on respiratory muscle strength, respiratory parameters, trunk control, upper extremity function and dysphagia 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.

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.

Conditions

Cerebral Palsy; Respiratory Muscle Training; Dysphagia; Balance Control; Functional Abilities; Respiratory Function Test

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Control Group

Participants in the control group will undergo a traditional physiotherapy programme for 8 weeks, consisting of two 40-minute sessions per week under the supervision of a physiotherapist.

Group Type: ACTIVE_COMPARATOR

Traditional Physiotherapy

Intervention Type: OTHER

Participants in the control group will undergo a neurodevelopmental-based traditional physiotherapy programme for 8 weeks, with two 40-minute sessions per week under the supervision of a physiotherapist; on other days, they will be asked to continue the exercises taught to their families at home.

Experimental Group

Participants in this group will receive inspiratory muscle training (IMT). IMT will be performed twice a week under the supervision of a physiotherapist and as a home exercise programme on the remaining days, for a total of eight weeks, five days a week, for 15 minutes a day. In addition, participants will receive traditional physical therapy treatments. In addition, participants will undergo an 8-week traditional physiotherapy programme consisting of two 40-minute sessions per week under the supervision of a physiotherapist.

Group Type: EXPERIMENTAL

Inspiratory Muscle Training and Traditional Physiotherapy

Intervention Type: OTHER

Participants in this group will undergo inspiratory muscle training (IMT). The resistance to be applied at the start of IMT has been set at 30% of the maximum inspiratory pressure (MIP) value. The MIP value will be remeasured every week, and the training load will be updated according to 30% of the new value obtained. IMT will be carried out twice a week with a physiotherapist and on the remaining days as a home programme, for a total of eight weeks, five days a week, 15 minutes a day. Participants in the experimental group will receive traditional physical therapy treatments for cerebral palsy in the same manner as the control group. In this context, traditional physical therapy methods based on neurodevelopmental principles will be applied and designed according to the individual's needs.

Interventions

Inspiratory Muscle Training and Traditional Physiotherapy

Participants in this group will undergo inspiratory muscle training (IMT). The resistance to be applied at the start of IMT has been set at 30% of the maximum inspiratory pressure (MIP) value. The MIP value will be remeasured every week, and the training load will be updated according to 30% of the new value obtained. IMT will be carried out twice a week with a physiotherapist and on the remaining days as a home programme, for a total of eight weeks, five days a week, 15 minutes a day. Participants in the experimental group will receive traditional physical therapy treatments for cerebral palsy in the same manner as the control group. In this context, traditional physical therapy methods based on neurodevelopmental principles will be applied and designed according to the individual's needs.

Intervention Type: OTHER

Traditional Physiotherapy

Participants in the control group will undergo a neurodevelopmental-based traditional physiotherapy programme for 8 weeks, with two 40-minute sessions per week under the supervision of a physiotherapist; on other days, they will be asked to continue the exercises taught to their families at home.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Level I or II according to the Gross Motor Function Classification System (GMFCS)
• Communication skills sufficient to understand spoken or written language
• Diagnosed with cerebral palsy (CP) by a paediatric neurologist
• Aged between 5 and 18 years old
• Participants whose families have given written consent to participate in the study will be included in the study.

Exclusion Criteria

• Those who have had a respiratory tract infection within the last month,
• Those with haemodynamic instability (heart rate > 150 beats/minute, systolic blood pressure > 140 mmHg or diastolic blood pressure > 90 mmHg),
• Those who have undergone orthopaedic surgery or botulinum toxin injection within the last six months,
• Participants with severe chest infections or existing respiratory problems that would prevent them from participating in the study,
• Participants with mental or auditory dysfunction that would prevent them from participating in the assessment and intervention processes are planned to be excluded from the study.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istanbul University - Cerrahpasa

OTHER

Sponsor Role: collaborator

Medipol University

OTHER

Sponsor Role: collaborator

Sadık Emre ÇELEBİ

OTHER

Sponsor Role: lead

Responsible Party

Sadık Emre ÇELEBİ

MSc, PhD(c), Physiotherapist

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Sadık E Çelebi, MSc, PhD(c), Physiotherapist

Role: STUDY_CHAIR

Istanbul University-Cerrahpaşa, Cardiology Institute, Department of Cardiology

Locations

Istanbul Medipol University

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

10840098-202.3.02-2938

Identifier Type: -

Identifier Source: org_study_id