NCT04310982

Brief Summary

Gait analysis is an effective tool used for a variety of purposes, including assessing neurological diseases, risk of falling, orthopedic disability and progress during rehabilitation.The analysis of gait and jump performance must be applicable in a clinical setting. Thus; it needs to be easy to apply in a variety of life situations.The measurements should be reproducible, stable, accurate, capable of distinguishing between normal and abnormal conditions, and cost-effective. Jump measures can predict injury risks, serve as talent identification, and replicate explosive competitive activities of athletes. Furthermore, the performance in vertical jumping can be associated with neuromuscular fatigue.The purpose of this study was to confirm the test-retest reliability of the G-walk wearable sensor system for gait and jump parameters in healthy adults.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 3, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2020

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

March 10, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 17, 2020

Completed
Last Updated

March 17, 2020

Status Verified

March 1, 2020

Enrollment Period

5 months

First QC Date

March 10, 2020

Last Update Submit

March 13, 2020

Conditions

Keywords

GaitJump performanceWearable inertial systemReliability

Outcome Measures

Primary Outcomes (2)

  • Gait Analysis

    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 7 days

  • Jump performance

    The jump tests protocols included; counter movement jump , squat jump and counter movement jump with arms thrust. At the end of the jump tests, all kinematic parameters concerning the evaluated jump were provided by the software. T Each participant performed a session of three trials for each of the assessed jumps. The jump with the maximum height was accepted for analysis.

    Reliability of the G-Walk in 7 days

Secondary Outcomes (3)

  • Jump height

    Reliability of the G-Walk in 7 days

  • Peak speed

    Reliability of the G-Walk in 7 days

  • Maximum concentric power

    Reliability of the G-Walk in 7 days

Study Arms (1)

Health Adults

Forty-nine healthy participants (30 females, 19 males) completed the test-retest protocol with 7 days between tests. Participants were; 23,58±2,65 years of age, 62,9±10,08 kg of weight and 168,76±8,31 cm of height. Participants included in the study did not have any musculoskeletal, neurological or other pathology potentially affecting their gait and jump performance.

Device: The G-Walk sensor system (G-Walk)

Interventions

The G-Walk is a wireless sensor device which is placed on an elastic belt and worn on the waist of the person being evaluated. The device is placed with the center of the device at the fifth lumbar vertebrae and the patient is completely free to walk, run and jump wearing this device. The gait and jump performance of the participants was assessed with the participants wearing this device two times to investigate the test-retest reliability. The second being 7 days after the first.

Also known as: Gait Analysis
Health Adults

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Healthy adults, 18-35 years old who do not have any concominant diseases.

You may qualify if:

  • Accepting to participate in the study,
  • Healthy adults,
  • Being 18-35 years old,

You may not qualify if:

  • having any musculoskeletal, neurological or other pathology potentially affecting their gait and jump performance,
  • Refusing to participate in the study,
  • Having limited cooperation which prevents participation in the study,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gazi University

Ankara, 06560, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Gait Analysis

Intervention Hierarchy (Ancestors)

GaitPhysical ExaminationDiagnostic Techniques and ProceduresDiagnosisPhysical Functional PerformancePhysical FitnessHealthPopulation Characteristics

Study Officials

  • Gokhan Yazici, Pt. PhD

    Gazi University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
7 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 10, 2020

First Posted

March 17, 2020

Study Start

June 3, 2019

Primary Completion

October 30, 2019

Study Completion

February 15, 2020

Last Updated

March 17, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations