Effects of Inspiratory Muscle Training in Children With Cerebral Palsy

NCT02998281 | Completed DMC

• 1 other identifier: 1234
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cerebral Palsy; Respiration; Decreased

Keywords

cerebral palsy; inspiratory muscle training

Outcome Measures

Primary Outcomes (1)

• Timed Up and Go Test

  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.

  6 weeks

Secondary Outcomes (5)

• Activities of daily living using with Pediatric Evaluation of Disability Inventory

  6 weeks

• Pulmonary Function Test

  6 weeks

• Respiratory muscle strength

  6 weeks

• Functional exercise capacity

  6 weeks

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

  6 weeks

Study Arms (2)

Treatment Group

ACTIVE COMPARATOR

The treatment group received Inspiratory muscle training (IMT) at 40% of maximal mouth pressure (PImax) by using Threshold IMT and training loads were adjusted to maintain 40% of the PImax weekly. The PImax was measured at supervised sessions each week, and 40% of the measured value was determined as the new training work load.

Device: Threshold (IMT)

Control Group

SHAM COMPARATOR

The control group received sham Inspiratory muscle training (IMT) at a fixed work load, 5% of PImax by using Threshold IMT.

Device: Threshold (IMT)

Interventions

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.

Control Group; Treatment Group

Eligibility Criteria

• Age: 7 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Gazi University: lead

Study Sites (1)

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

Ankara, 06500, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cerebral Palsy; Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Bulent Elbasan, Phd

  Gazi University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc Pt

Study Record Dates

• First Submitted: December 10, 2016
• First Posted: December 20, 2016
• Study Start: December 1, 2016
• Primary Completion: July 1, 2017
• Study Completion: December 1, 2017
• Last Updated: September 28, 2018

Record last verified: 2018-09

Locations

TU (1)