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Completed

NCT Number: NCT03396289

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.

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Key information

Conditions

Cerebral Palsy, Spastic Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Cerebral Palsy Nervous System Diseases

Age range

7 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bezmialem Vakif University

Istanbul, 34093, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Inspiratory Muscle Training

Other

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

Primary outcomes

  1. Change from baseline maximum inspiratory pressure at 8 weeks

    Time frame: Eight weeks

  2. Change from baseline maximum expiratory pressure at 8 weeks

    Time frame: Eight weeks

  3. Change from baseline distance covered in six-minute walk test at 8 weeks

    Time frame: Eight weeks

  4. Change from baseline Forced Vital Capacity (FVC) at 8 weeks

    Time frame: Eight weeks

  5. Change from baseline Forced Expiratory Volume in 1 second (FEV1) at 8 weeks

    Time frame: Eight weeks

  6. Change from baseline Peak Expiratory Flow (PEF) at 8 weeks

    Time frame: Eight weeks

  7. Change from baseline postural stability test score in Biodex Balance System SD at 8 weeks

    Time frame: Eight weeks

  8. Change from baseline limits of stability test score in Biodex Balance System SD at 8 weeks

    Time frame: Eight weeks

  9. Change from baseline sensory integration and balance test score in Biodex Balance System SD at 8 weeks

    Time frame: Eight weeks

Sponsors and collaborators

Lead sponsor

Bezmialem Vakif University

Other

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jan 10, 2018
Registry last updated
Jun 28, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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