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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Lower Limb Amputation

Intervention / Treatment
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* Device: KinetiGait


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Left transtibial<br>Left below knee amputation- 25 | Device: KinetiGait<br>* 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.<br>|
| Right transtibial<br>Right below knee amputation- 25 | Device: KinetiGait<br>* 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.<br>|
| Left transfemoral<br>Left above knee amputation- 25 | Device: KinetiGait<br>* 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.<br>|
| Right transfemoral<br>Right above knee amputation- 25 | Device: KinetiGait<br>* 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.<br>|
| Provider<br>Provider- 15 | Device: KinetiGait<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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depth camera, gait analysis, LE loss, SMs and Veterans