HealthyNCT04310982
The Reliability of a Wearable Inertial System in Healthy Adults.
An observational study of Healthy and Adult, run by Gazi University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- What is being tested?
- The G-Walk sensor system (G-Walk)
- Type of treatment
- Medical device
- How many people
- 49 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Jun 2019to 15 Feb 2020
- How long will I take part?
- 7 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy adults, 18-35 years old who do not have any concominant diseases.
Who may be able to join
- Accepting to participate in the study,
- Healthy adults,
- Being 18-35 years old,
Who cannot join
- 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,
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Reliability of a Wearable Inertial System (G-walk) on Gait and Jump Assessment in Healthy Adults.
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.
Read the 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.
- Being tested
- The G-Walk sensor system (G-Walk)
- Keywords
- Gait, Jump performance, Wearable inertial system, Reliability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The G-Walk sensor system (G-Walk)Device
Also called Gait Analysis
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: The G-Walk sensor system (G-Walk) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Reliability of the G-Walk in 7 days
Secondary outcomes (3)
Jump height
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.
Measured: Reliability of the G-Walk in 7 days
Peak speed
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.
Measured: Reliability of the G-Walk in 7 days
Maximum concentric power
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.
Measured: Reliability of the G-Walk in 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2020
- Study start3 Jun 2019
- Primary completion30 Oct 2019
- Study completion15 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 49 participants (actual)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gokhan Yazici, Gazi University
- Investigators
- Gokhan Yazici, Pt. PhD, Principal investigator, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04310982
- Sponsor's protocol ID
- Gazi U
- Status last verified
- Mar 2020
- First submitted
- 10 Mar 2020
- Last updated
- 17 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Reliability of a Wearable Inertial System (G-walk) on Gait and Jump Assessment in Healthy Adults.
- ClinicalTrials.gov ID
- NCT04310982
- Acronym / sponsor ID
- Gazi U
- Keywords
- Gait, Jump performance, Wearable inertial system, Reliability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 3 Jun 2019 (actual)
- Primary completion
- 30 Oct 2019 (actual)
- Study completion
- 15 Feb 2020 (actual)
- First posted
- 17 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 7 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Health Adults | – | Device: The G-Walk sensor system (G-Walk)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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy adults, 18-35 years old who do not have any concominant diseases.
Key inclusion criteria (3 listed)
- Accepting to participate in the study,
- Healthy adults,
- Being 18-35 years old,
Key exclusion criteria (3 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The G-Walk sensor system (G-Walk)Also: Gait AnalysisThe 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. | Device | Health Adults |
Primary outcome
Gait Analysis
Time frame: Reliability of the G-Walk in 7 days
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.
Jump performance
Time frame: Reliability of the G-Walk in 7 days
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.
3 secondary outcomes
Jump height
Time frame: Reliability of the G-Walk in 7 days
Peak speed
Time frame: Reliability of the G-Walk in 7 days
Maximum concentric power
Time frame: Reliability of the G-Walk in 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gokhan Yazici, Pt. PhD principal investigator
Gazi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy and Adult, run by Gazi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gait Analysis (time frame: Reliability of the G-Walk in 7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2020.