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

NCT ID: NCT04240275

Last Updated: 2020-01-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 54 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-06-03
• Study Completion Date: 2019-12-30

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

Conditions

Cerebral Palsy, Spastic; Gait Disorders, Neurologic

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Children with Cerebral Palsy

Children diagnosed with Spastic Cerebral Palsy (Unilateral or Bilateral) among the age range of 5-15 who can walk independently

Reliability of the G-Walk device in children with Cerebral Palsy

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

Gait Analysis

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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gazi University

OTHER

Sponsor Role: lead

Responsible Party

Gokhan Yazici

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gokhan Yazici, Pt. PhD

Role: PRINCIPAL_INVESTIGATOR

Gazi University

Locations

Gazi University

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: BACKGROUND

PMID: 30747572 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29861240 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28698802 (View on PubMed)

Other Identifiers

12355

Identifier Type: -

Identifier Source: org_study_id