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

Henry M. Jackson Foundation for the Advancement of Military Medicine

Status: Completed

Conditions: Lower Limb Amputation

Treatments: Device: KinetiGait

Study type: Observational

Funder types: Other

Identifiers

NCT04431817

189608

Details and patient eligibility

About

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.

Full 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.

Enrollment: 41 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

41 participants in 5 patient groups

Left transtibial

Description:

Left below knee amputation- 25

Treatment:

Device: KinetiGait

Right transtibial

Description:

Right below knee amputation- 25

Treatment:

Device: KinetiGait

Left transfemoral

Description:

Left above knee amputation- 25

Treatment:

Device: KinetiGait

Right transfemoral

Description:

Right above knee amputation- 25

Treatment:

Device: KinetiGait

Provider

Description:

Provider- 15

Treatment:

Device: KinetiGait