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

Lower Limb Amputation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04431817
• Other study ID #: 189608
• Status: Not yet recruiting
• Start date: August 2021
• Est. completion date: December 2022

Study information

• Verified date: July 2021
• Source: Henry M. Jackson Foundation for the Advancement of Military Medicine
• Contact: Tiffany R Riggleman, AAS
• Phone: (301)707-9681
• Email: tiffany.r.riggleman.ctr[@]mail.mil
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 115
• Est. completion date: December 2022
• Est. primary completion date: August 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Lower Limb Amputation

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Patient-Reported Outcomes Measurement Information System (PROMIS)-29	Measures self-reported capability rather than actual performance of physical capabilities.	5-10 minutes
Secondary	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