Skip to main content
OpenTrials
Completed

NCT Number: NCT04431817

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Lower Limb Amputation

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

KinetiGait

Device

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.

Primary outcomes

  1. Prosthetic Limb Users Survey of Mobility (PLUS-M)

    Time frame: 5-10 minutes

    12-item short form to assess functional status, quality of life and perceived mobility.

  2. Patient-Reported Outcomes Measurement Information System (PROMIS)-29

    Time frame: 5-10 minutes

    Measures self-reported capability rather than actual performance of physical capabilities.

Secondary outcomes

  1. Provider survey

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Henry M. Jackson Foundation for the Advancement of Military Medicine

Other

Collaborators

  • Telemedicine & Advanced Technology Research Center

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jun 16, 2020
Registry last updated
Jul 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.