Health, SubjectiveNCT06157749
Gait Assessment Via Telephone Application
An observational study of Health, Subjective, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
The evaluation of human gait is a crucial component of the clinical assessment and decision-making process. The gold standard in gait analysis is computerized gait analysis, which allows for three-dimensional digital data acquisition through computers (3D Computerized Gait Analysis). Read more about this study
- Who is it for?
- Ages 18 to 26 years
- Conditions the study is for
- Health, Subjective
- What is being tested?
- Gait analysis
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 31 Jul 2024to Sep 2025
- How long will I take part?
- 1 Week
- 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 26 years
- All sexes
- Adult
Study population: Volunteers willing to participate in the study and who meet the inclusion criteria of being healthy
Who may be able to join
- Age between 18 and 26 years.
- Body Mass Index (BMI) within normal limits (18.5-24.9 kg/m2)
Who cannot join
- Presence of lower extremity rotational problems (such as high femoral anteversion, internal tibial torsion, metatarsus adductus).
- History of Botulinum Toxin Type A (BoNT-A) application or surgery within the last 6 months.
- History of lower extremity injury within the last 6 months.
- Leg length discrepancy.
- Presence of third-degree pes planus.
- Any neurological, rheumatic, musculoskeletal, metabolic, or connective tissue diseases.
- History of pain, deformity, or surgery related to the vertebral column and upper extremities.
- Presence of cognitive, mental, and/or severe psychiatric disorders
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
Acibadem Mehmet Ali Aydinlar University
Istanbul, 34752
Tekin K Ulku, Assoc. Prof., +902166494444, tekin.ulku@acibadem.edu.tr
About this study
Official title: Validity and Reliability of a Smartphone Application for Gait Assessment
The evaluation of human gait is a crucial component of the clinical assessment and decision-making process. The gold standard in gait analysis is computerized gait analysis, which allows for three-dimensional digital data acquisition through computers (3D Computerized Gait Analysis). However, this technology is not readily accessible in routine analyses, as it proves to be a time-consuming and expensive endeavor in terms of infrastructure and human resources. The utilization of smartphones in clinical applications is on the rise, facilitated by the increasing accessibility of low-cost or free "applications," thereby addressing the limitations associated with traditional gait analysis methods. The Gait-Analyzer application is among the mentioned applications. However, in the literature, no evidence has been found regarding the validity and reliability of Gait-Analyzer application compared to the gold standard 3D computerized gait analysis systems within the context of gait analyses.
The aim of this study is to comparatively examine the effectiveness of the Gait-Analyzer smartphone application with established 3D Computerized Gait Analysis systems, which have proven validity and reliability in gait analyses. Through this research, the study intends to elucidate the validity and reliability of spatiotemporal parameters of walking within the Gait-Analyzer smartphone application.
Read the detailed description
Voluntary healthy participants will be included in the study. Signed voluntary consent will be obtained from participants. Participants will be divided into two groups. 3D Computerized Gait Analysis will be applied to one group first, and Gait-Analyzer smarthphone application will be applied to the other group first.
- Conditions
- Health, Subjective
- Being tested
- Gait analysis
- Keywords
- 3D Computerized Gait Analysis, Gait-Analyzer, Gait Analysis, Smartphone Application
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gait analysisOther
It will be carried out on a 10-meter flat surface, with the participant walking at normal walking speed.
| Study group | Role | What they receive |
|---|---|---|
| 3D Computerized Gait Analysis | The gait analysis will be conducted through 3D computerized gait analysis. Receives: Other: Gait analysis | |
| Gait-Analyzer | The gait analysis will be performed using a smartphone application called Gait-Analyzer. Receives: Other: Gait analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Three-Dimensional Computerized Gait Analysis
Reflective markers are placed on specific anatomical points to record varying joint angles throughout the walking cycle. Patients walk a distance of 9-10 meters, capturing records of their walking patterns and speed in everyday life, either barefoot or using assistive walking devices.
Measured: change from baseline at first week
Gait-Analyzer
Gait-Analyzer is a mobile application for smartphones capable of real-time analysis of walking parameters. Using a smartphone with an Android processor and the "Gait Analyzer" application, directly attached to the participants' lumbar spine (nearest to L5) with a waist belt, participants will be instructed to complete 6 laps (12 forward and backward walks) on a 10-meter walking path.
Measured: change from baseline at first week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2023
- Study start31 Jul 2024
- Primary completionJul 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Health, SubjectiveStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 34 participants (estimated)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aysenur Erekdag, Istanbul University - Cerrahpasa
- Investigators
- Ayşenur Erekdağ, MSc, Principal investigator, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06157749
- Sponsor's protocol ID
- 93402A830
- Status last verified
- Mar 2025
- First submitted
- 27 Nov 2023
- Last updated
- 24 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Stuberg WA, Colerick VL, Blanke DJ, Bruce W. Comparison of a clinical gait analysis method using videography and temporal-distance measures with 16-mm cinematography. Phys Ther. 1988 Aug;68(8):1221-5.
PubMed 3399519Norris BS, Olson SL. Concurrent validity and reliability of two-dimensional video analysis of hip and knee joint motion during mechanical lifting. Physiother Theory Pract. 2011 Oct;27(7):521-30. doi: 10.3109/09593985.2010.533745. Epub 2011 May 15.
PubMed 21568816Finkbiner MJ, Gaina KM, McRandall MC, Wolf MM, Pardo VM, Reid K, Adams B, Galen SS. Video Movement Analysis Using Smartphones (ViMAS): A Pilot Study. J Vis Exp. 2017 Mar 14;(121):54659. doi: 10.3791/54659.
PubMed 28362382Kelly M, Jones P, Wuebbles R, Lugade V, Cipriani D, Murray NG. A novel smartphone application is reliable for repeat administration and comparable to the Tekscan Strideway for spatiotemporal gait. Measurement (Lond). 2022 Mar 31;192:110882. doi: 10.1016/j.measurement.2022.110882. Epub 2022 Feb 11.
PubMed 35369360
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity and Reliability of a Smartphone Application for Gait Assessment
- ClinicalTrials.gov ID
- NCT06157749
- Acronym / sponsor ID
- 93402A830
- Conditions
- Health, Subjective
- Keywords
- 3D Computerized Gait Analysis, Gait-Analyzer, Gait Analysis, Smartphone Application
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 31 Jul 2024 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 6 Dec 2023 (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.
The evaluation of human gait is a crucial component of the clinical assessment and decision-making process. The gold standard in gait analysis is computerized gait analysis, which allows for three-dimensional digital data acquisition through computers (3D Computerized Gait Analysis). However, this technology is not readily accessible in routine analyses, as it proves to be a time-consuming and expensive endeavor in terms of infrastructure and human resources. The utilization of smartphones in clinical applications is on the rise, facilitated by the increasing accessibility of low-cost or free "applications," thereby addressing the limitations associated with traditional gait analysis methods. The Gait-Analyzer application is among the mentioned applications. However, in the literature, no evidence has been found regarding the validity and reliability of Gait-Analyzer application compared to the gold standard 3D computerized gait analysis systems within the context of gait analyses.
The aim of this study is to comparatively examine the effectiveness of the Gait-Analyzer smartphone application with established 3D Computerized Gait Analysis systems, which have proven validity and reliability in gait analyses. Through this research, the study intends to elucidate the validity and reliability of spatiotemporal parameters of walking within the Gait-Analyzer smartphone application.
Detailed description
Voluntary healthy participants will be included in the study. Signed voluntary consent will be obtained from participants. Participants will be divided into two groups. 3D Computerized Gait Analysis will be applied to one group first, and Gait-Analyzer smarthphone application will be applied to the other group first.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Week
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3D Computerized Gait Analysis | – | Other: Gait analysisThe gait analysis will be conducted through 3D computerized gait analysis. |
| Gait-Analyzer | – | Other: Gait analysisThe gait analysis will be performed using a smartphone application called Gait-Analyzer. |
Who may qualify
- Ages
- 18 to 26 years
- Sex
- All
- Age groups
- Adult
- Study population
- Volunteers willing to participate in the study and who meet the inclusion criteria of being healthy
Key inclusion criteria (2 listed)
- Age between 18 and 26 years.
- Body Mass Index (BMI) within normal limits (18.5-24.9 kg/m2)
Key exclusion criteria (8 listed)
- Presence of lower extremity rotational problems (such as high femoral anteversion, internal tibial torsion, metatarsus adductus).
- History of Botulinum Toxin Type A (BoNT-A) application or surgery within the last 6 months.
- History of lower extremity injury within the last 6 months.
- Leg length discrepancy.
- Presence of third-degree pes planus.
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 |
|---|---|---|
| Gait analysisIt will be carried out on a 10-meter flat surface, with the participant walking at normal walking speed. | Other | 3D Computerized Gait Analysis, Gait-Analyzer |
Primary outcome
Three-Dimensional Computerized Gait Analysis
Time frame: change from baseline at first week
Reflective markers are placed on specific anatomical points to record varying joint angles throughout the walking cycle. Patients walk a distance of 9-10 meters, capturing records of their walking patterns and speed in everyday life, either barefoot or using assistive walking devices.
Gait-Analyzer
Time frame: change from baseline at first week
Gait-Analyzer is a mobile application for smartphones capable of real-time analysis of walking parameters. Using a smartphone with an Android processor and the "Gait Analyzer" application, directly attached to the participants' lumbar spine (nearest to L5) with a waist belt, participants will be instructed to complete 6 laps (12 forward and backward walks) on a 10-meter walking path.
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 24 Mar 2025.
- Background: PubMed 3399519Stuberg WA, Colerick VL, Blanke DJ, Bruce W. Comparison of a clinical gait analysis method using videography and temporal-distance measures with 16-mm cinematography. Phys Ther. 1988 Aug;68(8):1221-5.
- Background: PubMed 21568816Norris BS, Olson SL. Concurrent validity and reliability of two-dimensional video analysis of hip and knee joint motion during mechanical lifting. Physiother Theory Pract. 2011 Oct;27(7):521-30. doi: 10.3109/09593985.2010.533745. Epub 2011 May 15.
- Background: PubMed 28362382Finkbiner MJ, Gaina KM, McRandall MC, Wolf MM, Pardo VM, Reid K, Adams B, Galen SS. Video Movement Analysis Using Smartphones (ViMAS): A Pilot Study. J Vis Exp. 2017 Mar 14;(121):54659. doi: 10.3791/54659.
- Background: PubMed 35369360Kelly M, Jones P, Wuebbles R, Lugade V, Cipriani D, Murray NG. A novel smartphone application is reliable for repeat administration and comparable to the Tekscan Strideway for spatiotemporal gait. Measurement (Lond). 2022 Mar 31;192:110882. doi: 10.1016/j.measurement.2022.110882. Epub 2022 Feb 11.
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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.
Ayşenur Erekdağ, MSc principal investigator
Bezmialem Vakif 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 Health, Subjective, run by Istanbul University - Cerrahpasa 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 2 inclusion and 8 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 24 Mar 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 Ayşenur Erekdağ, MSc (05548959013, aysenurerekdag@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Three-Dimensional Computerized Gait Analysis (time frame: change from baseline at first week). 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?
On the ClinicalTrials.gov record for NCT06157749, which also lists 4 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 24 Mar 2025.