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
1 other identifier
observational
41
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Aug 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 11, 2020
CompletedFirst Posted
Study publicly available on registry
June 16, 2020
CompletedStudy Start
First participant enrolled
August 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 14, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 28, 2023
CompletedJuly 20, 2025
July 1, 2025
1.6 years
June 11, 2020
July 16, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (1)
Provider survey
5-10 minutes
Study Arms (5)
Left transtibial
Left below knee amputation- 25
Right transtibial
Right below knee amputation- 25
Left transfemoral
Left above knee amputation- 25
Right transfemoral
Right above knee amputation- 25
Provider
Provider- 15
Interventions
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.
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- K0-K1 Medicare Functional Classification Levels
- Physically unstable or requires an ambulatory device
- Pregnant women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889, United States
Related Publications (1)
B Aledi L, Flumignan CD, Trevisani VF, Miranda F Jr. Interventions for motor rehabilitation in people with transtibial amputation due to peripheral arterial disease or diabetes. Cochrane Database Syst Rev. 2023 Jun 5;6(6):CD013711. doi: 10.1002/14651858.CD013711.pub2.
PMID: 37276273DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Gabriel M Kim, M.D.
WRNMMC
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 11, 2020
First Posted
June 16, 2020
Study Start
August 1, 2021
Primary Completion
March 14, 2023
Study Completion
March 28, 2023
Last Updated
July 20, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share