- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04310982
The Reliability of a Wearable Inertial System in Healthy Adults.
The Reliability of a Wearable Inertial System (G-walk) on Gait and Jump Assessment in Healthy Adults.
Study Overview
Status
Intervention / Treatment
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.
After the accelerometer was placed, the participants were asked to walk calmly at normal speed, on a 10 m track, and to return to the starting position.
The values and gait characteristics of acceleration in the anteroposterior and mediolateral 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 Following gait assessment, Countermovement jump, static squat jump and Countermovement jump with arms thrust was measured using the device.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Ankara, Turkey, 06560
- Gazi University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Accepting to participate in the study,
- Healthy adults,
- Being 18-35 years old,
Exclusion Criteria:
- 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,
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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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.
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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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Gait Analysis
Time Frame: Reliability of the G-Walk in 7 days
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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
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Jump performance
Time Frame: Reliability of the G-Walk in 7 days
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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.
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Reliability of the G-Walk in 7 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Jump height
Time Frame: Reliability of the G-Walk in 7 days
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The jump tests protocols included; counter movement jump , squat jump and counter movement jump with arms thrust.
At the end of the jump tests, the height of the jump was given in centimeters by the software.
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Reliability of the G-Walk in 7 days
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Peak speed
Time Frame: Reliability of the G-Walk in 7 days
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The jump tests protocols included; counter movement jump , squat jump and counter movement jump with arms thrust.
At the end of the jump tests, the peak speed of the jump was given in meters/second by the software.
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Reliability of the G-Walk in 7 days
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Maximum concentric power
Time Frame: Reliability of the G-Walk in 7 days
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The jump tests protocols included; counter movement jump , squat jump and counter movement jump with arms thrust.
At the end of the jump tests, the maximum concentric power of the jump was given in Newtons by the software.
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Reliability of the G-Walk in 7 days
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Gazi U
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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