KinetiGait- Analysis of Depth Camera to Assist Gait Analysis for Unilateral Transtibial/Transfemoral Amputees
- Conditions
- Lower Limb Amputation
- Registration Number
- NCT04431817
- Lead Sponsor
- Henry M. Jackson Foundation for the Advancement of Military Medicine
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 41
- 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
- K0-K1 Medicare Functional Classification Levels
- Physically unstable or requires an ambulatory device
- Pregnant women
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.
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
Name Time Method 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.
Trial Locations
- Locations (1)
Walter Reed National Military Medical Center
🇺🇸Bethesda, Maryland, United States
Walter Reed National Military Medical Center🇺🇸Bethesda, Maryland, United States