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NCT Number: NCT02998281

Effects of Inspiratory Muscle Training in Children With Cerebral Palsy

Even if cerebral palsy not directly effect respiratory system, impairment of nervous and muscle systems, because of the brain damage, may cause respiratory functions impairment. In literature, it has been showed that children with cerebral palsy have decreased respiratory muscle strength and associated with trunk control, quality of life and respiratory functions. But, there is no study in literature that aims to increase respiratory muscle strength in these children. Hence, the aim of this study is to investigate effects of inspiratory muscle training on respiratory functions, trunk control, activities of daily living, functional exercise capacity and quality of life in children with cerebral palsy.

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Nervous System Diseases Respiration Disorders Respiration; Decreased Respiratory Insufficiency Respiratory Tract Diseases

Age range

7 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gazi University, Faculty of Health and Sciences, Department of Physiotherapy and Rehabilitation

Ankara, 06500, Turkey (Türkiye)

About this study

A convenience of children with hemiparetic and diplegia CP, 7-14 years, is going to recruited from Gazi University, Faculty of Health Science, Department of Physiotherapy and Rehabilitation. Patients will randomly allocate to either a treatment group or control group. The treatment group will receive inspiratory muscle training at 30-40% of maximal mouth pressure, the control group will receive sham inspiratory muscle training at a fixed work load, 5% of maximal mouth pressure. Groups are going to train for a total of 30 min/d, 7 days/week, for 6 weeks. Before and after treatment, every each of patients pulmonary function test will be evaluated with using spirometry, respiratory muscle strength using with electronic mouth pressure device, trunk control with using trunk control measurement scale, activities of daily living using with Pediatric Evaluation of Disability Inventory (PEDI), functional exercise capacity usin with six minute walk test (6MWT) and quality of life using with Cerebral Palsy Quality of Life Questionnaire (CPQOL).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 7-14 years
  • Diagnosed to spastic cerebral palsy
  • Gross Motor Function Classification System levels I or II.
  • Have no earlier interventions in the form of orthopaedic surgery or injection with botulinum toxin type A in the 6 month prior to baseline assessments
  • Child are able to demonstrate sufficient co-operation and cognitive understanding participating

Exclusion criteria

  • Active medical condition impairment (pneumonia etc.)
  • Do not accommodate the study
  • Do not want to attempt the study

Treatment and study plan

Threshold (IMT)

Device

Training is going to perform by using a pressure threshold- loading device (Threshold, IMT, USA) used to inhale against a same-pressure load every inhalation for strengthening primarily the diaphragm and rib cage muscles. The device pressure is adjusted according to PImax, and reliability/reproducibility has been demonstrated.

Primary outcomes

  1. Timed Up and Go Test

    Time frame: 6 weeks

    this is a simple test used to assess a person's mobility and requires both static and dynamic balance. It uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair and sit down. During the test, the child is expected to wear their regular footwear and use any mobility aids that they would normally require.

Secondary outcomes

  1. Activities of daily living using with Pediatric Evaluation of Disability Inventory

    Time frame: 6 weeks

    PEDI scale

  2. Pulmonary Function Test

    Time frame: 6 weeks

    spirometry

  3. Respiratory muscle strength

    Time frame: 6 weeks

    Mouth pressure device

  4. Functional exercise capacity

    Time frame: 6 weeks

    six minute walk test

  5. Change in trunk control over time assessed with Trunk Control Measurement Scale

    Time frame: 6 weeks

    Assessing change in trunk control

Sponsors and collaborators

Lead sponsor

Gazi University

Other

Registry information

Official study title

Effects of Inspiratory Muscle Training on Respiratory Functions, Trunk Control, Activities of Daily Living, Functional Exercise Capacity and Quality of Life in Children With Cerebral Palsy

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Dec 20, 2016
Registry last updated
Sep 28, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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