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

• ClinicalTrials.gov Identifier: NCT03396289
• Recruitment Status: Completed
• First Posted: January 10, 2018
• Last Update Posted: June 28, 2018
• Sponsor: Bezmialem Vakif University
• Information provided by (Responsible Party): Büşra Kepenek Varol, Bezmialem Vakif University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Cerebral Palsy, Spastic	Other: Conventional physiotherapy including balance exercises; Other: Inspiratory muscle training	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: February 23, 2018
• Actual Primary Completion Date: June 25, 2018
• Actual Study Completion Date: June 25, 2018

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

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 ]

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

Turkey

Bezmialem Vakif University

Istanbul, Turkey, 34093

Sponsors and Collaborators

Bezmialem Vakif University

More Information

• Responsible Party: Büşra Kepenek Varol, Lecturer, PT, MSc, Bezmialem Vakif University
• ClinicalTrials.gov Identifier: NCT03396289
• Other Study ID Numbers: bvubkvarol01
• First Posted: January 10, 2018
• Last Update Posted: June 28, 2018
• Last Verified: June 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Büşra Kepenek Varol, Bezmialem Vakif University:

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

Additional relevant MeSH terms:

Paralysis; Cerebral Palsy; Neurologic Manifestations; Nervous System Diseases; Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases