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

S

Sadık Emre ÇELEBİ

Status

Completed

Conditions

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

Treatments

Other: Traditional Physiotherapy
Other: Inspiratory Muscle Training and Traditional Physiotherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT07041593
10840098-202.3.02-2938

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 patients

Sex

All

Ages

5 to 18 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

20 participants in 2 patient groups

Control Group
Active Comparator group
Description:
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.
Treatment:
Other: Traditional Physiotherapy
Experimental Group
Experimental group
Description:
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.
Treatment:
Other: Inspiratory Muscle Training and Traditional Physiotherapy

Trial contacts and locations

1

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Central trial contact

Hande Tunç, MSc, PhD(c), Physiotherapist; Sadık E Çelebi, MSc, PhD(c), Physiotherapist

Data sourced from clinicaltrials.gov

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