Effects of Inspiratory Muscle Training in Children With Cerebral Palsy

Cerebral Palsy Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02998281
• Other study ID #: 1234
• Status: Completed
• Phase: N/A
• Start date: December 2016
• Est. completion date: December 2017

Study information

• Verified date: September 2018
• Source: Gazi University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: December 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 14 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy
• Paralysis
• Respiration; Decreased
• Respiratory Aspiration

Intervention

Device:
• Threshold (IMT)
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.

Locations

Country	Name	City	State
Turkey	Gazi University, Faculty of Health and Sciences, Department of Physiotherapy and Rehabilitation	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Gazi University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Activities of daily living using with Pediatric Evaluation of Disability Inventory	PEDI scale	6 weeks
Secondary	Pulmonary Function Test	spirometry	6 weeks
Secondary	Respiratory muscle strength	Mouth pressure device	6 weeks
Secondary	Functional exercise capacity	six minute walk test	6 weeks
Secondary	Change in trunk control over time assessed with Trunk Control Measurement Scale	Assessing change in trunk control	6 weeks