Clinical trial NCT06157749: Gait Assessment Via Telephone Application
Official title: Validity and Reliability of a Smartphone Application for Gait Assessment
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Health, Subjective
Keywords: 3D Computerized Gait Analysis
Gait-Analyzer
Gait Analysis
Smartphone Application
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2023-12-06
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 26
Standard ages: ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Volunteers willing to participate in the study and who meet the inclusion criteria of being healthy

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Three-Dimensional Computerized Gait Analysis
timeFrame: change from baseline at first week
measure: Gait-Analyzer
timeFrame: change from baseline at first week
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Acibadem Mehmet Ali Aydinlar University
Study officials:
affiliation: Bezmialem Vakif University
name: Ayşenur Erekdağ, MSc
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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.
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.