Clinical trial NCT04240275: Reliability of a Body-worn Sensor System for Gait Analysis in Children With CP
Official title: Reliability of a Body-worn Sensor System for Analysis of Spatiotemporal Gait Parameters in Children With CP
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Palsy, Spastic
Gait Disorders, Neurologic
Keywords: Cerebral Palsy
Gait Assessment
G-Walk
Reliability
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2020-01-27
Enrollment: 54
Sex: ALL
Minimum age (years): 5
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children with Spastic Cerebral Palsy who have involvement on one or two sides of the body, who can walk independently.

Brief summary: Cerebral palsy (CP) is caused by a non-progressive injury in the developing brain, which leads to problems in functional mobility, posture, neuro musculoskeletal functions and gait. Around 75% of children with CP are ambulatory however they have gait problems such as excessive knee flexion, stiff knee, crouch gait or equinus which affects the quality of gait. When constructing an effective treatment plan in children with CP, a comprehensive assessment should be performed. One of the most essential assessments is gait analysis. Gait analysis is used in the quantitative assessment of gait disturbances providing functional diagnosis, assessment for treatment, planning, and monitoring of progress.

Gait analysis aims to determine the factors leading to gait disturbances. To reach this aim, a large amount of quantitative data concerning the gait characteristics of a patient is analyzed. The assessment of these data can be performed via standardized clinical videos, recorded with numerical video cameras used in conjunction with optical 3D systems. The purpose of this study was to confirm the test-retest reliability of a commercially available body-worn sensor- G-Walk® sensor system-for spatiotemporal gait parameters in children with CP.

Detailed description: The G-Walk determines spatiotemporal parameters as well as pelvic rotations during gait and allows objective and precise analysis of movements with its wearable inertial sensor. It also enables 3D kinematic analysis of the pelvis, providing a functional analysis of disorders in gait caused by neuromuscular diseases The device is placed on an elastic belt and worn on the waist of the person being evaluated, with the center of the device at the fifth lumbar vertebrae. To ensure correct placement of the device, the L4-L5 intervertebral space was palpated via the posterior superior iliac spines (SIPS).

After the accelerometer was placed, the children were asked to walk calmly at normal speed, on a 10 m track, whose boundaries were determined with colored lines and to return to the starting position.

The values and gait characteristics of acceleration in the anteroposterior (AP) and mediolateral (ML) axes were transferred to the computer software program.

The tilt of the pelvis in the sagittal plane in the flexion-extension direction, the oblique displacement in the coronal plane, the angles of the rotation of movement in the transverse plane and the symmetry values of the right and left sides are obtained. While the symmetry index ranges from 0 to 100, a value closer to 100 indicates that the gait is more symmetrical

Eligibility criteria: Inclusion Criteria:

* Accepting to participate in the study,
* Being between 5-15 years old,
* Having a diagnosis of Spastic Cerebral Palsy,
* Being level I-II according to GMFCS

Exclusion Criteria:

* Having limited cooperation which prevents participation in the study,
* Refusing to participate in the study,
* Having an orthopedic disorder or systemic illness which prevents movement in the lower extremities,
* Having a Botulinum toxin application in the last 3 month

Primary outcomes:
measure: Gait Symmetry
timeFrame: Reliability of the G-Walk in 3 days
measure: Gait Speed
timeFrame: Reliability of the G-Walk in 3 days
measure: Spatiotemporal gait parameters
timeFrame: Reliability of the G-Walk in 3 days
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University
Study officials:
affiliation: Gazi University
name: Gokhan Yazici, Pt. PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: De Ridder R, Lebleu J, Willems T, De Blaiser C, Detrembleur C, Roosen P. Concurrent Validity of a Commercial Wireless Trunk Triaxial Accelerometer System for Gait Analysis. J Sport Rehabil. 2019 Aug 1;28(6):jsr.2018-0295. doi: 10.1123/jsr.2018-0295.
citation: Kleiner AFR, Pacifici I, Vagnini A, Camerota F, Celletti C, Stocchi F, De Pandis MF, Galli M. Timed Up and Go evaluation with wearable devices: Validation in Parkinson's disease. J Bodyw Mov Ther. 2018 Apr;22(2):390-395. doi: 10.1016/j.jbmt.2017.07.006. Epub 2017 Jul 25.
citation: Armand S, Decoulon G, Bonnefoy-Mazure A. Gait analysis in children with cerebral palsy. EFORT Open Rev. 2016 Dec 22;1(12):448-460. doi: 10.1302/2058-5241.1.000052. eCollection 2016 Dec.