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

NCT03396289 | Completed

• 1 other identifier: bvubkvarol01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy, Spastic

Keywords

Cerebral Palsy; Balance; Inspiratory Muscle Training; 6-Minute Walk Test; Pulmonary Function Test; Postural Stability

Outcome Measures

Primary Outcomes (9)

• 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

Study Arms (2)

Control Group

ACTIVE COMPARATOR

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

Training Group

EXPERIMENTAL

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; Other: Inspiratory muscle training

Interventions

Conventional physiotherapy including balance exercises OTHER

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.

Control Group; Training Group

Inspiratory muscle training OTHER

Threshold IMT device will be used for the training. Training intensity will set at 30% of the maximum inspiratory pressure.

Training Group

Eligibility Criteria

• Age: 7 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bezmialem Vakif University: lead

Study Sites (1)

Bezmialem Vakif University

Istanbul, 34093, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer, PT, MSc

Study Record Dates

• First Submitted: January 5, 2018
• First Posted: January 10, 2018
• Study Start: February 23, 2018
• Primary Completion: June 25, 2018
• Study Completion: June 25, 2018
• Last Updated: June 28, 2018

Record last verified: 2018-06

Locations

TU (1)