The Effects of Balance and Respiratory Muscle Training on Functional Capacity, Balance, Respiratory Function and Respiratory Muscle Strength in Children With Cerebral Palsy

Not Applicable

Completed

• Conditions: Cerebral Palsy, Spastic
• Interventions: Other: Conventional physiotherapy including balance exercises; Other: Inspiratory muscle training

• Registration Number: NCT03396289
• Lead Sponsor: Bezmialem Vakif University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-01-05
• Study First Submitted QC: 2018-01-05
• Study First Posted: 2018-01-10
• Study Start: 2018-02-23
• Status Verified: 2018-06
• Primary Completion: 2018-06-25
• Study Completion: 2018-06-25
• Last Update Submitted: 2018-06-27
• Last Update Posted: 2018-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Training Group	Conventional physiotherapy including balance exercises	In addition to conventional physiotherapy programme, patients in this group will also receive inspiratory muscle training for 15 minutes, twice a day, 7 days a week for 8 weeks. One exercise session will be performed under the supervision of a physiotherapist, other sessions will be performed at home.
Control Group	Conventional physiotherapy including balance exercises	Patients in this group will receive conventional physiotherapy programme including balance exercises, 3 times a week for 8 weeks. One exercise session will be performed under the supervision of a physiotherapist, other 2 sessions will be performed at home.
Training Group	Inspiratory muscle training	In addition to conventional physiotherapy programme, patients in this group will also receive inspiratory muscle training for 15 minutes, twice a day, 7 days a week for 8 weeks. One exercise session will be performed under the supervision of a physiotherapist, other sessions will be performed at home.

Primary Outcome Measures

Name	Time	Method
Change from baseline maximum inspiratory pressure at 8 weeks	Eight weeks
Change from baseline maximum expiratory pressure at 8 weeks	Eight weeks
Change from baseline distance covered in six-minute walk test at 8 weeks	Eight weeks
Change from baseline Forced Vital Capacity (FVC) at 8 weeks	Eight weeks
Change from baseline Forced Expiratory Volume in 1 second (FEV1) at 8 weeks	Eight weeks
Change from baseline Peak Expiratory Flow (PEF) at 8 weeks	Eight weeks
Change from baseline postural stability test score in Biodex Balance System SD at 8 weeks	Eight weeks
Change from baseline limits of stability test score in Biodex Balance System SD at 8 weeks	Eight weeks
Change from baseline sensory integration and balance test score in Biodex Balance System SD at 8 weeks	Eight weeks

Trial Locations

Locations (1)

Bezmialem Vakif University; 🇹🇷 Istanbul, Turkey