Healthy AdultsNCT06994793
Validity and Reliability of Gait and Jump Parameters Measured by the iSen Device in Healthy Adults
An observational study of Healthy Adults and Gait Analysis, run by Kırıkkale University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to evaluate the validity and reliability of gait and jumping parameters measured with the iSen device in healthy adults. Gait analysis is a valuable tool for assessing general health, cognitive performance, quality of life, and mortality. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adults, Gait Analysis, Jumping Performance
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jan 2025to 1 Feb 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: The study population consists of healthy adult volunteers aged 18 to 35 years who have not undergone lower extremity surgery and have no musculoskeletal, neurological, or systemic conditions that could affect gait or jumping performance. Participants will be recruited from Gazi University and Kırıkkale University, Department of Physiotherapy and Rehabilitation.
Who may be able to join
- Age between 18 and 35 years. Voluntarily agree to participate in the study. No history of surgery in the lower extremities.
Who cannot join
- Any musculoskeletal, neurological, or systemic pathology that could affect gait or jumping performance.
- Inability to comply with study procedures.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Kirikkale University
Kirikkale
Muhammed Yusuf DEMIRKAN, +905453065511, myusufdemirkan@gmail.com
Muhammed Yusuf Demirkan
About this study
Official title: Investigation of the Validity and Reliability of Gait and Jumping Parameters Measured With iSen Device in Healthy Adults
This study aims to evaluate the validity and reliability of gait and jumping parameters measured with the iSen device in healthy adults. Gait analysis is a valuable tool for assessing general health, cognitive performance, quality of life, and mortality. It is commonly used by clinicians to assess functional limitations resulting from neurological or orthopedic conditions and to guide treatment plans. Traditional gait assessments primarily focus on walking speed, but additional parameters such as step length, step time, and gait symmetry are crucial for a comprehensive analysis.
The study will also assess vertical jump performance, which is a surrogate measure of explosive lower limb strength and is commonly used in sports performance and injury prediction. The iSen device, a wearable and affordable sensor, will be compared to the validated BTS G-Walk system to evaluate the accuracy and consistency of its measurements. Participants aged 18-35 with no history of musculoskeletal, neurological, or systemic conditions will be included.
The study will be conducted at Gazi University and Kırıkkale University, where participants will undergo assessments of gait and jump performance using both iSen and BTS G-Walk devices. A test-retest reliability protocol will be employed with a seven-day interval between measurements. The results will provide evidence on the suitability of the iSen device for reliable and valid gait and jump measurements in clinical settings
Read the detailed description
This study seeks to evaluate the validity and reliability of gait and jumping parameters measured with the iSen device in healthy adults. Gait analysis is an important tool in clinical settings as it provides valuable information about an individual's general health, cognitive performance, quality of life, and mortality risk. It is particularly useful for identifying functional limitations resulting from neurological or orthopedic conditions. Clinicians often rely on gait analysis to customize treatment plans, monitor individual progress, and assess the therapeutic benefits of interventions. Additionally, gait analysis can help identify underlying abnormalities and disorders that contribute to reduced functionality, thus aiding clinical decision-making.
Traditionally, clinical gait assessments focus on walking speed, typically measured using timed walking tests such as the 10-meter walk test or the 6-minute walk test. However, these assessments often fall short of providing a comprehensive evaluation, as they do not account for other important gait parameters such as step length, step time, or gait symmetry. Spatio-temporal gait parameters, such as walking speed, step time, step length, and step width, are essential for evaluating changes that may predict fall risk. Moreover, they are important for understanding motor function in a variety of populations.
Currently, laboratory-based equipment such as 3D motion capture systems and force plates are considered the gold standard for gait analysis due to their precision. However, these systems are often costly, require large spaces, and demand significant time for setup and analysis. As a result, they are not always accessible in clinical environments. In recent years, wearable accelerometers have gained popularity as an alternative for gait analysis. These devices offer several advantages, including low cost, portability, ease of use, and the ability to perform assessments in real-world settings, such as walking corridors. Notably, accelerometer-based gait analysis can be completed in a short period, typically within 10 minutes, making it an efficient option for clinical practice.
In addition to gait analysis, vertical jump performance is also a key parameter for assessing lower extremity strength and explosive power. Jumping performance can provide insights into athletic ability, physical fitness, and injury risk. Vertical jump height, in particular, is widely used by physiotherapists, trainers, and health professionals to assess strength, neuromuscular fatigue, and explosive power. Several methods are used to measure jump height, including contact mats, force plates, and accelerometers. However, force plates, considered the gold standard, are not portable and require specialized expertise to operate. As a result, wearable sensors like the iSen device have emerged as a practical and cost-effective alternative for jump performance analysis.
The iSen device is a wearable, wireless sensor that offers advantages over traditional laboratory-based equipment due to its portability, affordability, and ease of use. However, there is limited evidence regarding the validity and reliability of the iSen device in measuring gait and jump parameters. This study aims to fill this gap by comparing the iSen device with the validated BTS G-Walk system, which has demonstrated reliability and validity in gait and jump assessments. By evaluating the performance of the iSen device in measuring spatio-temporal gait parameters and jump performance, the study seeks to provide evidence for its potential clinical use.
The study will be conducted at Gazi University and Kırıkkale University, and will involve healthy adult participants aged 18-35 who meet the inclusion criteria. Participants will be screened for musculoskeletal, neurological, or systemic disorders that could affect their gait or jump performance. Each participant will undergo a series of assessments using both the iSen and BTS G-Walk devices. The assessments will include gait analysis in a 7-meter walking course, as well as vertical jump tests. To assess the test-retest reliability of the iSen device, participants will be re-assessed after a seven-day interval.
This study will contribute to the evidence base on the validity and reliability of the iSen device in measuring gait and jump parameters. The findings will provide valuable insights for clinicians and healthcare providers, helping them determine whether the iSen device can serve as a reliable, cost-effective alternative to traditional gait and jump assessment methods in clinical practice.
- Keywords
- Gait Analysis, Jumping Performance, iSen Device, Wearable Sensors, Reliability, Validity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Adults | Healthy adult volunteers aged 18 to 35 years with no history of lower extremity surgery or any musculoskeletal, neurological, or systemic conditions that could affect gait or jumping performance. Participants were recruited from university departments and underwent gait and jumping assessments using the iSen and BTS G-Walk devices. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait Speed
Gait speed (m/s) will be measured using the iSen system at baseline and one week later. At baseline, measurements will also be collected using the BTS G-Walk system for comparison to determine the validity of the iSen device in healthy adults.
Measured: Baseline and 1 week later
Cadence
Cadence (steps/min) will be measured using the iSen system at baseline and one week later. At baseline, BTS G-Walk measurements will be used for validity comparison.
Measured: Baseline and 1 week later
Step Length
Step length (m) will be measured using the iSen system at baseline and one week later. At baseline, BTS G-Walk measurements will be used for validity comparison.
Measured: Baseline and 1 week later
Stance Phase Duration
Stance phase duration (%) will be measured using the iSen system at baseline and one week later. BTS G-Walk will be used at baseline for validation.
Measured: Baseline and 1 week later
Step Time
Step time (s) will be measured using the iSen system at baseline and one week later. BTS G-Walk will be used at baseline for comparison.
Measured: Baseline and 1 week later
Swing Phase Duration
Swing phase duration (%) will be measured using the iSen system at baseline and one week later. BTS G-Walk will be used at baseline for validation.
Measured: Baseline and 1 week later
Double Support Phase Duration
Double support phase duration (%) will be measured using the iSen system at baseline and one week later. BTS G-Walk will be used at baseline for validation.
Measured: Baseline and 1 week later
Single Support Phase Duration
Single support phase duration (%) will be measured using the iSen system at baseline and one week later. BTS G-Walk will be used at baseline for validation
Measured: Baseline and 1 week later
Pelvic Angles
Pelvic angles (degrees) will be measured using the iSen system at baseline and one week later. BTS G-Walk will be used at baseline for validation
Measured: Baseline and 1 week later
Jump Height
Jump height (cm) will be measured during a countermovement jump using both the iSen and BTS G-Walk systems at baseline, and only the iSen system one week later. The highest value from three jumps will be recorded.
Measured: Baseline and 1 week later
Take-off Force
Take-off force (kN) during a countermovement jump will be measured with the iSen and BTS G-Walk systems at baseline, and with iSen only one week later. The trial with the highest value will be analyzed.
Measured: Baseline and 1 week later
Maximum Concentric Power
Maximum concentric power (kN) during a countermovement jump will be measured using both iSen and BTS G-Walk systems at baseline, and only iSen at one week. The value from the best trial will be used for analysis.
Measured: Baseline and 1 week later
Landing Impact Force
Landing impact force (kN) will be assessed using both the iSen and BTS G-Walk systems at baseline, and the iSen system only at one-week follow-up.
Measured: Baseline and 1 week later
Maximum Jump Velocity
Maximum vertical velocity (m/s) during a countermovement jump will be measured using the iSen and BTS G-Walk systems at baseline, and only iSen one week later. The maximum value from three trials will be recorded.
Measured: Baseline and 1 week later
Take-off Velocity
Take-off velocity (m/s) will be assessed during a countermovement jump using both the iSen and BTS G-Walk systems at baseline, and only iSen at 1-week follow-up. The highest value will be selected.
Measured: Baseline and 1 week later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2025
- Study start10 Jan 2025
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Healthy AdultsStudies of the same condition, open and under way.
- 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kırıkkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Saniye Aydoğan Arslan, Kırıkkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06994793
- Sponsor's protocol ID
- KirikkaleUni-iSenSağlıklı
- Status last verified
- May 2025
- First submitted
- 6 May 2025
- Last updated
- 29 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30747572Yazici MV, Cobanoglu G, Yazici G. Test-retest reliability and minimal detectable change for measures of wearable gait analysis system (G-Walk) in children with cerebral palsy. Turk J Med Sci. 2022 Jun;52(3):658-666. doi: 10.55730/1300-0144.5358. Epub 2022 Jun 16.
PubMed 36326313
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Validity and Reliability of Gait and Jumping Parameters Measured With iSen Device in Healthy Adults
- ClinicalTrials.gov ID
- NCT06994793
- Acronym / sponsor ID
- KirikkaleUni-iSenSağlıklı
- Keywords
- Gait Analysis, Jumping Performance, iSen Device, Wearable Sensors, Reliability, Validity
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Kırıkkale UniversityUniversity, hospital or other
- Study start
- 10 Jan 2025 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 29 May 2025 (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.
This study aims to evaluate the validity and reliability of gait and jumping parameters measured with the iSen device in healthy adults. Gait analysis is a valuable tool for assessing general health, cognitive performance, quality of life, and mortality. It is commonly used by clinicians to assess functional limitations resulting from neurological or orthopedic conditions and to guide treatment plans. Traditional gait assessments primarily focus on walking speed, but additional parameters such as step length, step time, and gait symmetry are crucial for a comprehensive analysis.
The study will also assess vertical jump performance, which is a surrogate measure of explosive lower limb strength and is commonly used in sports performance and injury prediction. The iSen device, a wearable and affordable sensor, will be compared to the validated BTS G-Walk system to evaluate the accuracy and consistency of its measurements. Participants aged 18-35 with no history of musculoskeletal, neurological, or systemic conditions will be included.
The study will be conducted at Gazi University and Kırıkkale University, where participants will undergo assessments of gait and jump performance using both iSen and BTS G-Walk devices. A test-retest reliability protocol will be employed with a seven-day interval between measurements. The results will provide evidence on the suitability of the iSen device for reliable and valid gait and jump measurements in clinical settings
Detailed description
This study seeks to evaluate the validity and reliability of gait and jumping parameters measured with the iSen device in healthy adults. Gait analysis is an important tool in clinical settings as it provides valuable information about an individual's general health, cognitive performance, quality of life, and mortality risk. It is particularly useful for identifying functional limitations resulting from neurological or orthopedic conditions. Clinicians often rely on gait analysis to customize treatment plans, monitor individual progress, and assess the therapeutic benefits of interventions. Additionally, gait analysis can help identify underlying abnormalities and disorders that contribute to reduced functionality, thus aiding clinical decision-making.
Traditionally, clinical gait assessments focus on walking speed, typically measured using timed walking tests such as the 10-meter walk test or the 6-minute walk test. However, these assessments often fall short of providing a comprehensive evaluation, as they do not account for other important gait parameters such as step length, step time, or gait symmetry. Spatio-temporal gait parameters, such as walking speed, step time, step length, and step width, are essential for evaluating changes that may predict fall risk. Moreover, they are important for understanding motor function in a variety of populations.
Currently, laboratory-based equipment such as 3D motion capture systems and force plates are considered the gold standard for gait analysis due to their precision. However, these systems are often costly, require large spaces, and demand significant time for setup and analysis. As a result, they are not always accessible in clinical environments. In recent years, wearable accelerometers have gained popularity as an alternative for gait analysis. These devices offer several advantages, including low cost, portability, ease of use, and the ability to perform assessments in real-world settings, such as walking corridors. Notably, accelerometer-based gait analysis can be completed in a short period, typically within 10 minutes, making it an efficient option for clinical practice.
In addition to gait analysis, vertical jump performance is also a key parameter for assessing lower extremity strength and explosive power. Jumping performance can provide insights into athletic ability, physical fitness, and injury risk. Vertical jump height, in particular, is widely used by physiotherapists, trainers, and health professionals to assess strength, neuromuscular fatigue, and explosive power. Several methods are used to measure jump height, including contact mats, force plates, and accelerometers. However, force plates, considered the gold standard, are not portable and require specialized expertise to operate. As a result, wearable sensors like the iSen device have emerged as a practical and cost-effective alternative for jump performance analysis.
The iSen device is a wearable, wireless sensor that offers advantages over traditional laboratory-based equipment due to its portability, affordability, and ease of use. However, there is limited evidence regarding the validity and reliability of the iSen device in measuring gait and jump parameters. This study aims to fill this gap by comparing the iSen device with the validated BTS G-Walk system, which has demonstrated reliability and validity in gait and jump assessments. By evaluating the performance of the iSen device in measuring spatio-temporal gait parameters and jump performance, the study seeks to provide evidence for its potential clinical use.
The study will be conducted at Gazi University and Kırıkkale University, and will involve healthy adult participants aged 18-35 who meet the inclusion criteria. Participants will be screened for musculoskeletal, neurological, or systemic disorders that could affect their gait or jump performance. Each participant will undergo a series of assessments using both the iSen and BTS G-Walk devices. The assessments will include gait analysis in a 7-meter walking course, as well as vertical jump tests. To assess the test-retest reliability of the iSen device, participants will be re-assessed after a seven-day interval.
This study will contribute to the evidence base on the validity and reliability of the iSen device in measuring gait and jump parameters. The findings will provide valuable insights for clinicians and healthcare providers, helping them determine whether the iSen device can serve as a reliable, cost-effective alternative to traditional gait and jump assessment methods in clinical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Adults | – | –Healthy adult volunteers aged 18 to 35 years with no history of lower extremity surgery or any musculoskeletal, neurological, or systemic conditions that could affect gait or jumping performance. Participants were recruited from university departments and underwent gait and jumping assessments using the iSen and BTS G-Walk devices. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study population consists of healthy adult volunteers aged 18 to 35 years who have not undergone lower extremity surgery and have no musculoskeletal, neurological, or systemic conditions that could affect gait or jumping performance. Participants will be recruited from Gazi University and Kırıkkale University, Department of Physiotherapy and Rehabilitation.
Key inclusion criteria (1 listed)
- Age between 18 and 35 years. Voluntarily agree to participate in the study. No history of surgery in the lower extremities.
Key exclusion criteria (2 listed)
- Any musculoskeletal, neurological, or systemic pathology that could affect gait or jumping performance.
- Inability to comply with study procedures.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Gait Speed
Time frame: Baseline and 1 week later
Gait speed (m/s) will be measured using the iSen system at baseline and one week later. At baseline, measurements will also be collected using the BTS G-Walk system for comparison to determine the validity of the iSen device in healthy adults.
Cadence
Time frame: Baseline and 1 week later
Cadence (steps/min) will be measured using the iSen system at baseline and one week later. At baseline, BTS G-Walk measurements will be used for validity comparison.
Step Length
Time frame: Baseline and 1 week later
Step length (m) will be measured using the iSen system at baseline and one week later. At baseline, BTS G-Walk measurements will be used for validity comparison.
Stance Phase Duration
Time frame: Baseline and 1 week later
Stance phase duration (%) will be measured using the iSen system at baseline and one week later. BTS G-Walk will be used at baseline for validation.
Step Time
Time frame: Baseline and 1 week later
Step time (s) will be measured using the iSen system at baseline and one week later. BTS G-Walk will be used at baseline for comparison.
Swing Phase Duration
Time frame: Baseline and 1 week later
Swing phase duration (%) will be measured using the iSen system at baseline and one week later. BTS G-Walk will be used at baseline for validation.
Double Support Phase Duration
Time frame: Baseline and 1 week later
Double support phase duration (%) will be measured using the iSen system at baseline and one week later. BTS G-Walk will be used at baseline for validation.
Single Support Phase Duration
Time frame: Baseline and 1 week later
Single support phase duration (%) will be measured using the iSen system at baseline and one week later. BTS G-Walk will be used at baseline for validation
Pelvic Angles
Time frame: Baseline and 1 week later
Pelvic angles (degrees) will be measured using the iSen system at baseline and one week later. BTS G-Walk will be used at baseline for validation
Jump Height
Time frame: Baseline and 1 week later
Jump height (cm) will be measured during a countermovement jump using both the iSen and BTS G-Walk systems at baseline, and only the iSen system one week later. The highest value from three jumps will be recorded.
Take-off Force
Time frame: Baseline and 1 week later
Take-off force (kN) during a countermovement jump will be measured with the iSen and BTS G-Walk systems at baseline, and with iSen only one week later. The trial with the highest value will be analyzed.
Maximum Concentric Power
Time frame: Baseline and 1 week later
Maximum concentric power (kN) during a countermovement jump will be measured using both iSen and BTS G-Walk systems at baseline, and only iSen at one week. The value from the best trial will be used for analysis.
Landing Impact Force
Time frame: Baseline and 1 week later
Landing impact force (kN) will be assessed using both the iSen and BTS G-Walk systems at baseline, and the iSen system only at one-week follow-up.
Maximum Jump Velocity
Time frame: Baseline and 1 week later
Maximum vertical velocity (m/s) during a countermovement jump will be measured using the iSen and BTS G-Walk systems at baseline, and only iSen one week later. The maximum value from three trials will be recorded.
Take-off Velocity
Time frame: Baseline and 1 week later
Take-off velocity (m/s) will be assessed during a countermovement jump using both the iSen and BTS G-Walk systems at baseline, and only iSen at 1-week follow-up. The highest value will be selected.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2025.
- Background: PubMed 30747572De 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.
- Background: PubMed 36326313Yazici MV, Cobanoglu G, Yazici G. Test-retest reliability and minimal detectable change for measures of wearable gait analysis system (G-Walk) in children with cerebral palsy. Turk J Med Sci. 2022 Jun;52(3):658-666. doi: 10.55730/1300-0144.5358. Epub 2022 Jun 16.
- 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.
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 Adults and Gait Analysis, run by Kırıkkale 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 1 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 29 Aug 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Saniye AYDOGAN ARSLAN (+905053333457, fztsaniye1982@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gait Speed (time frame: Baseline and 1 week later). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06994793, which also lists 2 linked publications.
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 29 Aug 2025.