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

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.

Study Overview

• Status: Completed
• Conditions: Lower Limb Amputation
• Intervention / Treatment: Device: KinetiGait

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 Type: Observational
• Enrollment (Actual): 41

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Bethesda, Maryland, United States, 20889
      • Walter Reed National Military Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

The study population will include individuals who are DEERS-eligible between the ages of 18 and 65 and in K2-K4 Medical Functional Classification levels. The providers must be MHS providers.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Left transtibial; Left below knee amputation- 25	Device: KinetiGait; 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.
Right transtibial; Right below knee amputation- 25	Device: KinetiGait; 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.
Left transfemoral; Left above knee amputation- 25	Device: KinetiGait; 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.
Right transfemoral; Right above knee amputation- 25	Device: KinetiGait; 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.
Provider; Provider- 15	Device: KinetiGait; 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine
• Collaborators: Telemedicine & Advanced Technology Research Center
• Investigators: Principal Investigator: Gabriel M Kim, M.D., WRNMMC

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2021
• Primary Completion (Actual): March 14, 2023
• Study Completion (Actual): March 28, 2023

Study Registration Dates

• First Submitted: June 11, 2020
• First Submitted That Met QC Criteria: June 11, 2020
• First Posted (Actual): June 16, 2020

Study Record Updates

• Last Update Posted (Actual): July 20, 2025
• Last Update Submitted That Met QC Criteria: July 16, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: depth camera, gait analysis, LE loss, SMs and Veterans
• Other Study ID Numbers: 189608

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No