Gait Assessment Via Telephone Application

Health, Subjective Clinical Trial

Official title:

Validity and Reliability of a Smartphone Application for Gait Assessment

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06157749
• Other study ID #: 93402A830
• Status: Not yet recruiting
• Start date: April 2024
• Est. completion date: April 2025

Study information

• Verified date: March 2024
• Source: Istanbul University - Cerrahpasa (IUC)
• Contact: Aysenur Erekdag, MSc
• Phone: 05548959013
• Email: aysenurerekdag[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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). 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 34
• Est. completion date: April 2025
• Est. primary completion date: December 2024
• Gender: All
• Age group: 18 Years to 26 Years

Eligibility

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

Related Conditions & MeSH terms

• Health, Subjective

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University - Cerrahpasa (IUC)

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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