Clinical trial NCT03417726: Evaluation of Pediatric Balance Scale and Quantitative Balance Parameters in Patients With Cerebral Palsy
Official title: "Evaluation of Pediatric Balance Scale and Quantitative Balance Parameters in Patients With Cerebral Palsy"
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cerebral Palsy, Spastic
Balance; Distorted
Keywords: Cerebral Palsy
Balance
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2018-01-31
Enrollment: 50
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Spastic Cerebral Palsy

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.

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

Primary outcomes:
measure: Modified Clinical Test of Sensory Interaction on Balance (mCTSIB) - Firm-Eyes Open
timeFrame: 2 min
Secondary outcomes:
measure: Modified Clinical Test of Sensory Interaction on Balance (mCTSIB) - Firm-Eyes Closed, Foam-Eyes Open, Foam-Eyes Closed
timeFrame: 3 min
measure: Limits of Stability (LOS)
timeFrame: 2 min
measure: Walk Across (WA)
timeFrame: 5 min
measure: Tandem Walk (TW)
timeFrame: 5 min
measure: Unilateral Stance (US)
timeFrame: 5 min
measure: Step/Quick Turn (SQT)
timeFrame: 5 min
measure: Pediatric Balance Scale (PBS)
timeFrame: 20 min
measure: Selective Control Assessment of the Lower Extremity (SCALE)
timeFrame: 15 min
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara University School of Medicine Department of Physical Medicine and Rehabilitation
Study officials:
affiliation: Marmara University School of Medicine, Pendik Research and Training Hospital, Department of Physical Medicine and Rehabilitation, Istanbul / Turkey 34890
name: Naime Evrim Karadag Saygi, Prof
role: STUDY_CHAIR
References:
citation: Franjoine MR, Gunther JS, Taylor MJ. Pediatric balance scale: a modified version of the berg balance scale for the school-age child with mild to moderate motor impairment. Pediatr Phys Ther. 2003 Summer;15(2):114-28. doi: 10.1097/01.PEP.0000068117.48023.18.
citation: Fowler EG, Staudt LA, Greenberg MB, Oppenheim WL. Selective Control Assessment of the Lower Extremity (SCALE): development, validation, and interrater reliability of a clinical tool for patients with cerebral palsy. Dev Med Child Neurol. 2009 Aug;51(8):607-14. doi: 10.1111/j.1469-8749.2008.03186.x. Epub 2009 Feb 12.
citation: Rosenbaum P, Paneth N, Leviton A, Goldstein M, Bax M, Damiano D, Dan B, Jacobsson B. A report: the definition and classification of cerebral palsy April 2006. Dev Med Child Neurol Suppl. 2007 Feb;109:8-14.
citation: Saether R, Helbostad JL, Riphagen II, Vik T. Clinical tools to assess balance in children and adults with cerebral palsy: a systematic review. Dev Med Child Neurol. 2013 Nov;55(11):988-99. doi: 10.1111/dmcn.12162. Epub 2013 May 16.