Effects of Inspiratory Muscle Training in Children With Cerebral Palsy

NCT ID: NCT02998281

Last Updated: 2018-09-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-31
• Study Completion Date: 2017-12-31

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.

Detailed 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).

Conditions

Cerebral Palsy; Respiration; Decreased

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Treatment Group

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.

Group Type: ACTIVE_COMPARATOR

Threshold (IMT)

Intervention Type: 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

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

Group Type: SHAM_COMPARATOR

Threshold (IMT)

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gazi University

OTHER

Sponsor Role: lead

Responsible Party

Muserrefe Nur Keles

MSc Pt

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bulent Elbasan, Phd

Role: STUDY_CHAIR

Gazi University

Locations

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

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

1234

Identifier Type: -

Identifier Source: org_study_id