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

NCT04240275 | Completed

• 1 other identifier: 12355
• Study Type: observational
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy, Spastic; Gait Disorders, Neurologic

Keywords

Cerebral Palsy; Gait Assessment; G-Walk; Reliability

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (1)

Children with Cerebral Palsy

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

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

Interventions

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

Also known as: Gait Analysis

Children with Cerebral Palsy

Eligibility Criteria

• Age: 5 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gazi University: lead

Study Sites (1)

Gazi University

Ankara, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 30747572 BACKGROUND

• 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.

  PMID: 29861240 BACKGROUND

• 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.

  PMID: 28698802 BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy; Gait Disorders, Neurologic

Interventions

Gait Analysis

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Gait; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Physical Functional Performance; Physical Fitness; Health; Population Characteristics

Study Officials

• Gokhan Yazici, Pt. PhD

  Gazi University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 20, 2020
• First Posted: January 27, 2020
• Study Start: June 3, 2019
• Primary Completion: September 30, 2019
• Study Completion: December 30, 2019
• Last Updated: January 27, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)