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Clinical Trials/NCT03417726
NCT03417726
Unknown
N/A

"Evaluation of Pediatric Balance Scale and Quantitative Balance Parameters in Patients With Cerebral Palsy"

Marmara University1 site in 1 country50 target enrollmentJanuary 1, 2018

Overview

Phase
N/A
Intervention
Not specified
Conditions
Cerebral Palsy, Spastic
Sponsor
Marmara University
Enrollment
50
Locations
1
Primary Endpoint
Modified Clinical Test of Sensory Interaction on Balance (mCTSIB) - Firm-Eyes Open
Last Updated
7 years ago

Overview

Brief Summary

This study aims to evaluate Pediatric Balance Scale and quantitative balance and gait parameters assessed by Balance Master force plate in Cerebral Palsy (CP) patients who are ambulatory without an assistive device in daily life.

Detailed Description

CP refers to a group of motion and posture disorders that limit activity and participation which is attributed to non-progressive disturbances in the developing fetus or infant brain. In CP, motor and sensory disorders are often accompanied by poor balance control. Impaired balance control leads to increased risk of falling, which is a major kinesiologic problem in children who are ambulatory without an assistive device. Functional balance in children is defined as the ability to maintain the center of gravity according to the base of support during typical childhood activities of daily living, school and play. The Pediatric Balance Scale, a modification of the Berg Balance Scale, was developed as a functional balance measure for children, easily administered without specialized equipment in a relatively short time. Balance Master® (Neurocom International Clackmas, Oregon, USA) is a device consisting of a system that processes signals from an 18x60 inch plaque that transmits the vertical forces exerted through patient's feet to measure center of gravity position and postural control through a software program. The aim of this study is to compare PBS results with quantitative balance and gait parameters obtained from Balance Master in spastic CP patients who are independently ambulatory. The level of correlation between these measurement methods will be examined and superiority to each other in assessing balance problems in this patient group will be evaluated.

Registry
clinicaltrials.gov
Start Date
January 1, 2018
End Date
June 1, 2019
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patients diagnosed with spastic cerebral palsy
  • Age between 4-18 years
  • Sufficient cooperation to understand instructions and participate evaluations
  • Gross Motor Function Classification System (GMFCS) level I-II
  • Giving an informed consent

Exclusion Criteria

  • Visual and vestibular deficits
  • Botulinum-toxin A treatment within 3 months or having undergone an orthopaedic surgery 1 year prior to inclusion in the study
  • Severe scoliosis (Cobb angle \>40°)
  • Uncontrolled seizures (Seizure in previous 6 months)
  • Having intrathecal baclofen pump
  • Having undergone selective dorsal rhizotomy

Outcomes

Primary Outcomes

Modified Clinical Test of Sensory Interaction on Balance (mCTSIB) - Firm-Eyes Open

Time Frame: 2 min

Evaluations will be done by Balance Master® (Neurocom International Clackmas, Oregon, USA) device which consists a system that processes signals from an 18x60 inch plaque that transmits the vertical forces exerted through patient's feet to measure center of gravity (COG) position and postural control through a software program. Each assessment will be made 3 times and average scores will be calculated via program. Mean COG Sway Velocity (deg/sec) during standing on a Firm Surface-Eyes Open is the primary outcome measure.

Secondary Outcomes

  • Tandem Walk (TW)(5 min)
  • Modified Clinical Test of Sensory Interaction on Balance (mCTSIB) - Firm-Eyes Closed, Foam-Eyes Open, Foam-Eyes Closed(3 min)
  • Limits of Stability (LOS)(2 min)
  • Walk Across (WA)(5 min)
  • Unilateral Stance (US)(5 min)
  • Step/Quick Turn (SQT)(5 min)
  • Pediatric Balance Scale (PBS)(20 min)
  • Selective Control Assessment of the Lower Extremity (SCALE)(15 min)

Study Sites (1)

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