Clinical trial NCT02998281: Effects of Inspiratory Muscle Training in Children With Cerebral Palsy
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Respiration; Decreased
Keywords: cerebral palsy
inspiratory muscle training
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2016-12-20
Enrollment: 25
Sex: ALL
Minimum age (years): 7
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

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

Primary outcomes:
measure: Timed Up and Go Test
timeFrame: 6 weeks
Secondary outcomes:
measure: Activities of daily living using with Pediatric Evaluation of Disability Inventory
timeFrame: 6 weeks
measure: Pulmonary Function Test
timeFrame: 6 weeks
measure: Respiratory muscle strength
timeFrame: 6 weeks
measure: Functional exercise capacity
timeFrame: 6 weeks
measure: Change in trunk control over time assessed with Trunk Control Measurement Scale
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University, Faculty of Health and Sciences, Department of Physiotherapy and Rehabilitation
Study officials:
affiliation: Gazi University
name: Bulent Elbasan, Phd
role: STUDY_CHAIR
References: