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

Completed
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
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

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
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)-295-10 minutes

Measures self-reported capability rather than actual performance of physical capabilities.

Secondary Outcome Measures
NameTimeMethod
Provider survey5-10 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

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