KinetiGait- Analysis of Depth Camera to Assist Gait Analysis for Unilateral Transtibial/Transfemoral Amputees

Completed

• Conditions: Lower Limb Amputation

• Registration Number: NCT04431817
• Lead Sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine

Brief Summary

This is a feasibility study about implementing and using the KinetiGait gait analysis system in clinical practice to enhance the rehabilitation of service members with lower limb disfunction. There will be questionnaires completed by participants and surveys completed by both participant and provider.

Detailed Description

We propose a feasibility study about implementing and using the KinetiGait gait analysis system in clinical practice to enhance the rehabilitation of service members with lower limb dysfunction. Up to 100 subjects will be consented, with the expectation that 80% (e.g., n=80) will complete the study with a complete dataset. Baseline sessions will consist of 7 minutes of walking at a self-selected speed between 0.7 and 1.3 m/s, after which participants will take the PLUS-M 12 Item Short Form and PROMIS-29 questionnaires, as well as a short survey. Participants will complete the questionnaires again at 1 month and 3 month. Providers who observed/operated the KinetiGait system will also take a short survey on ease of use and satisfaction.

Study Timeline

• Study First Submitted: 2020-06-11
• Study First Submitted QC: 2020-06-11
• Study First Posted: 2020-06-16
• Study Start: 2021-08-01
• Primary Completion: 2023-03-14
• Study Completion: 2023-03-28
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-16
• Last Update Posted: 2025-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

• Unilateral transfemoral or transtibial amputee
• Fitted by a prosthetist at a Military Treatment Facility
• K2-K4 Medicare Functional Classification Levels
• DEERS-eligible.
• For providers: MHS provider

Exclusion Criteria

• K0-K1 Medicare Functional Classification Levels
• Physically unstable or requires an ambulatory device
• Pregnant women

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prosthetic Limb Users Survey of Mobility (PLUS-M)	5-10 minutes	12-item short form to assess functional status, quality of life and perceived mobility.
Patient-Reported Outcomes Measurement Information System (PROMIS)-29	5-10 minutes	Measures self-reported capability rather than actual performance of physical capabilities.

Secondary Outcome Measures

Name	Time	Method
Provider survey	5-10 minutes	Survey for providers indicating age, level of clinical training, experience with gait analysis and views on integrating technology into the clinical environment.

Trial Locations

Locations (1)

Walter Reed National Military Medical Center; 🇺🇸 Bethesda, Maryland, United States