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

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.

Study Overview

• Status: Completed
• Conditions: Cerebral Palsy, Spastic
• Intervention / Treatment: Other: Conventional physiotherapy including balance exercises; Other: Inspiratory muscle training

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34093
    • Bezmialem Vakif University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 16 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control Group; 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.	Other: Conventional physiotherapy including balance exercises; Programme will include balance exercises with balance board and swiss ball, weight shifting exercises on board, one-legged balance, balance on unstable surface, balance on tilting surface and balance with Biodex Balance System. Biodex Balance System Biodex will only be used during sessions under physiotherapist supervision.
Experimental: Training Group; 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.	Other: Conventional physiotherapy including balance exercises; Programme will include balance exercises with balance board and swiss ball, weight shifting exercises on board, one-legged balance, balance on unstable surface, balance on tilting surface and balance with Biodex Balance System. Biodex Balance System Biodex will only be used during sessions under physiotherapist supervision.; Other: Inspiratory muscle training; Threshold IMT device will be used for the training. Training intensity will set at 30% of the maximum inspiratory pressure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 distance covered in six-minute walk test at 8 weeks	Eight weeks
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 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

Collaborators and Investigators

• Sponsor: Bezmialem Vakif University

Study record dates

Study Major Dates

• Study Start (Actual): February 23, 2018
• Primary Completion (Actual): June 25, 2018
• Study Completion (Actual): June 25, 2018

Study Registration Dates

• First Submitted: January 5, 2018
• First Submitted That Met QC Criteria: January 5, 2018
• First Posted (Actual): January 10, 2018

Study Record Updates

• Last Update Posted (Actual): June 28, 2018
• Last Update Submitted That Met QC Criteria: June 27, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: Cerebral Palsy; Balance; Postural Stability; Inspiratory Muscle Training; Pulmonary Function Test; 6-Minute Walk Test
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Brain Damage, Chronic; Cerebral Palsy; Paralysis
• Other Study ID Numbers: bvubkvarol01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No