Reliability of a Body-worn Sensor System for Gait Analysis in Children With CP

Gait Disorders, Neurologic Clinical Trial

Official title:

Reliability of a Body-worn Sensor System for Analysis of Spatiotemporal Gait Parameters in Children With CP

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04240275
• Other study ID #: 12355
• Status: Completed
• Start date: June 3, 2019
• Est. completion date: December 30, 2019

Study information

• Verified date: January 2020
• Source: Gazi University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: December 30, 2019
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy
• Cerebral Palsy, Spastic
• Gait Disorders, Neurologic
• Nervous System Diseases

Intervention

Device:
• Reliability of the G-Walk device in children with Cerebral Palsy
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. The children will be assessed with the G-Walk on two separate occasions.For the reliability analysis, the second measurement tests will be repeated 3 days after the first assessment. 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 will be palpated via the posterior superior iliac spines (SIPS). After the accelerometer is placed, the children are asked to walk calmly at normal speed, on a 10 m track, whose boundaries will be determined with colored lines and to return to the starting position.

Locations

Country	Name	City	State
Turkey	Gazi University	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Gazi University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. — View 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). pii: jsr.2018-0295. doi: 10.1123/jsr.2018-0295. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gait Symmetry	Gait parameters will be assessed via the G-Walk on two separate occasions. The G-Walk is a device that is worn on the waist via an elastic belt. The G-Walk is built with a triaxial accelerometer 16 bit/axes with multiple sensitivity, a triaxial magnetometer 13 bit and a triaxial gyroscope 16 bit/axes with multiple sensitivity. This hardware is capable of acquiring and transmitting data to a computer through a Bluetooth connection and at the end of each analysis an automatic report containing the gait assessment results is ready to be analyzed.; Gait symmetry values of the right and left sides are obtained within this report. While the symmetry index ranges from 0 to 100, a value closer to 100 indicates that the gait is more symmetrical.	Reliability of the G-Walk in 3 days
Primary	Gait Speed	Gait parameters will be assessed via the G-Walk on two separate occasions. The G-Walk is a device that is worn on the waist via an elastic belt. The G-Walk is built with a triaxial accelerometer 16 bit/axes with multiple sensitivity, a triaxial magnetometer 13 bit and a triaxial gyroscope 16 bit/axes with multiple sensitivity. This hardware is capable of acquiring and transmitting data to a computer through a Bluetooth connection and at the end of each analysis an automatic report containing the gait assessment results is ready to be analyzed.; For each subject, mean gait speed will be calculated from 10 consecutive steps in the gait cycles.	Reliability of the G-Walk in 3 days
Primary	Spatiotemporal gait parameters	Gait parameters will be assessed via the G-Walk on two separate occasions. The G-Walk is a device that is worn on the waist via an elastic belt. The G-Walk is built with a triaxial accelerometer 16 bit/axes with multiple sensitivity, a triaxial magnetometer 13 bit and a triaxial gyroscope 16 bit/axes with multiple sensitivity. This hardware is capable of acquiring and transmitting data to a computer through a Bluetooth connection and at the end of each analysis an automatic report containing the gait assessment results is ready to be analyzed.; The device provides the data for the following spatiotemporal gait parameters in one single report; Cadence Stance Phase (%of gait) Swing Phase (%of gait) Stride Length (cm)	Reliability of the G-Walk in 3 days