Clinical trial NCT03396289: The Effects of Balance and Respiratory Muscle Training on Functional Capacity, Balance, Respiratory Function and Respiratory Muscle Strength in Children With Cerebral Palsy
Official title: The Effects of Balance and Respiratory Muscle Training on Functional Capacity, Balance, Respiratory Function and Respiratory Muscle Strength in Children With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy, Spastic
Keywords: Cerebral Palsy
Balance
Inspiratory Muscle Training
6-Minute Walk Test
Pulmonary Function Test
Postural Stability
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2018-01-10
Enrollment: 30
Sex: ALL
Minimum age (years): 7
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Cerebral palsy (CP) is a permanent, non-progressive disorder in which the immature brain is affected by various causes in the prenatal, perinatal or postnatal period. Damage to the central nervous system in children with CP causes motor problems, balance and postural disorders. It is reported in the literature that the effects of balance and the effects of balance exercises in children with CP, similarly respiratory effects were also investigated. Balance and balance responses are especially important in children with ambulatory SP and balance problems are seen in most CP children. Insufficient control of respiratory muscles affects pulmonary ventilation negatively in children with CP. However, it seems that CP has limited articles in which respiratory muscle strength is investigated, and also limited studies involving inspiratory muscle training. Inspiratory muscle training is shown to improve pulmonary function and diaphragm (which is one of the core muscles) strength and have an effect on balance. Studies showed that respiratory muscle strength in children with CP is lower than in children with normal development. Nevertheless, there was no study showing the effects of respiratory muscle training on functional capacity and balance in children with CP. The aim of this study is to investigate the effects of balance training and inspiratory muscle training on functional capacity, balance, respiratory function and respiratory muscle strength in children with CP.


Eligibility criteria: Inclusion Criteria:

* Cerebral palsy diagnosis
* Children with level I or II according to Gross Motor Classification System

Exclusion Criteria:

* Orthopedic surgery and / or Botox application in the lower extremity in the last 6 months
* Severe convulsions that can not be controlled by drugs
* Congenital malformation accompanying cerebral palsy

Primary outcomes:
measure: Change from baseline maximum inspiratory pressure at 8 weeks
timeFrame: Eight weeks
measure: Change from baseline maximum expiratory pressure at 8 weeks
timeFrame: Eight weeks
measure: Change from baseline distance covered in six-minute walk test at 8 weeks
timeFrame: Eight weeks
measure: Change from baseline Forced Vital Capacity (FVC) at 8 weeks
timeFrame: Eight weeks
measure: Change from baseline Forced Expiratory Volume in 1 second (FEV1) at 8 weeks
timeFrame: Eight weeks
measure: Change from baseline Peak Expiratory Flow (PEF) at 8 weeks
timeFrame: Eight weeks
measure: Change from baseline postural stability test score in Biodex Balance System SD at 8 weeks
timeFrame: Eight weeks
measure: Change from baseline limits of stability test score in Biodex Balance System SD at 8 weeks
timeFrame: Eight weeks
measure: Change from baseline sensory integration and balance test score in Biodex Balance System SD at 8 weeks
timeFrame: Eight weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bezmialem Vakif University
Study officials:
References: