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, Spastic Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03396289
• Other study ID #: bvubkvarol01
• Status: Completed
• Phase: N/A
• Start date: February 23, 2018
• Est. completion date: June 25, 2018

Study information

• Verified date: June 2018
• Source: Bezmialem Vakif University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 25, 2018
• Est. primary completion date: June 25, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy
• Cerebral Palsy, Spastic
• Paralysis

Intervention

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

Locations

Country	Name	City	State
Turkey	Bezmialem Vakif University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Bezmialem Vakif University

Country where clinical trial is conducted

Turkey, 

Outcome

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