NCT06157749

Brief 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). 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
34

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 27, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 6, 2023

Completed
8 months until next milestone

Study Start

First participant enrolled

July 31, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

March 24, 2025

Status Verified

March 1, 2025

Enrollment Period

11 months

First QC Date

November 27, 2023

Last Update Submit

March 21, 2025

Conditions

Keywords

3D Computerized Gait AnalysisGait-AnalyzerGait AnalysisSmartphone Application

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    change from baseline at first week

Study Arms (2)

3D Computerized Gait Analysis

The gait analysis will be conducted through 3D computerized gait analysis.

Other: Gait analysis

Gait-Analyzer

The gait analysis will be performed using a smartphone application called Gait-Analyzer.

Other: Gait analysis

Interventions

It will be carried out on a 10-meter flat surface, with the participant walking at normal walking speed.

3D Computerized Gait AnalysisGait-Analyzer

Eligibility Criteria

Age18 Years - 26 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Volunteers willing to participate in the study and who meet the inclusion criteria of being healthy

You may qualify if:

  • Age between 18 and 26 years.
  • Body Mass Index (BMI) within normal limits (18.5-24.9 kg/m2)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Acibadem Mehmet Ali Aydinlar University

Istanbul, 34752, Turkey (Türkiye)

RECRUITING

Related Publications (4)

  • 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.

    PMID: 3399519BACKGROUND
  • 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.

    PMID: 21568816BACKGROUND
  • 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.

    PMID: 28362382BACKGROUND
  • 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.

    PMID: 35369360BACKGROUND

MeSH Terms

Interventions

Gait Analysis

Intervention Hierarchy (Ancestors)

GaitPhysical ExaminationDiagnostic Techniques and ProceduresDiagnosisPhysical Functional PerformancePhysical FitnessHealthPopulation Characteristics

Study Officials

  • Ayşenur Erekdağ, MSc

    Bezmialem Vakif University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ayşenur Erekdağ, MSc

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
1 Week
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 27, 2023

First Posted

December 6, 2023

Study Start

July 31, 2024

Primary Completion

July 1, 2025

Study Completion

September 1, 2025

Last Updated

March 24, 2025

Record last verified: 2025-03

Locations