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

Operational Analysis of Depth Camera to Assist Gait Analysis in Outpatient Rehabilitation for Unilateral Transtibial and Transfemoral Amputees

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04431817

Enrollment

Registered

2020-06-16

Start date

2021-08-01

Completion date

2023-03-28

Last updated

2025-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lower Limb Amputation

Keywords

depth camera, gait analysis, LE loss, SMs and Veterans

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.

Interventions

DEVICEKinetiGait

This device is an Intel RGB depth camera that relays video to gait analysis software. The images will be taken from amputees walking at a self-selected pace on a treadmill.

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026