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

Sponsor
Henry M. Jackson Foundation for the Advancement of Military Medicine (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04431817
Collaborator
Telemedicine & Advanced Technology Research Center (Other)
115
16

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
115 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Operational Analysis of Depth Camera to Assist Gait Analysis in Outpatient Rehabilitation for Unilateral Transtibial and Transfemoral Amputees
Anticipated Study Start Date :
Aug 1, 2021
Anticipated Primary Completion Date :
Aug 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Henry M. Jackson Foundation for the Advancement of Military Medicine
  • Telemedicine & Advanced Technology Research Center

Investigators

  • Principal Investigator: Gabriel M Kim, M.D., WRNMMC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Henry M. Jackson Foundation for the Advancement of Military Medicine
ClinicalTrials.gov Identifier:
NCT04431817
Other Study ID Numbers:
  • 189608
First Posted:
Jun 16, 2020
Last Update Posted:
Jul 27, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Henry M. Jackson Foundation for the Advancement of Military Medicine

Study Results

No Results Posted as of Jul 27, 2021