- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06157749
Gait Assessment Via Telephone Application
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.
Study Overview
Detailed Description
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Ayşenur Erekdağ, MSc
- Phone Number: 05548959013
- Email: aysenurerekdag@gmail.com
Study Locations
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Istanbul, Turkey, 34752
- Recruiting
- Acibadem Mehmet Ali Aydinlar University
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Contact:
- Tekin K Ulku, Assoc. Prof.
- Phone Number: +902166494444
- Email: tekin.ulku@acibadem.edu.tr
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age between 18 and 26 years.
- Body Mass Index (BMI) within normal limits (18.5-24.9 kg/m2)
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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3D Computerized Gait Analysis
The gait analysis will be conducted through 3D computerized gait analysis.
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It will be carried out on a 10-meter flat surface, with the participant walking at normal walking speed.
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Gait-Analyzer
The gait analysis will be performed using a smartphone application called Gait-Analyzer.
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It will be carried out on a 10-meter flat surface, with the participant walking at normal walking speed.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Three-Dimensional Computerized Gait Analysis
Time Frame: change from baseline at first week
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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.
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change from baseline at first week
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Gait-Analyzer
Time Frame: change from baseline at first week
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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.
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change from baseline at first week
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ayşenur Erekdağ, MSc, Bezmialem Vakif University
Publications and helpful links
General 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.
- Norris 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.
- Finkbiner 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.
- Kelly 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
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
- 93402A830
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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