Clinical trial NCT02886936: Immediate Fit Using Innovative Technology Transtibial & Transfemoral Prosthesis
Official title: Immediate Fit Using Innovative Technology Transtibial & Transfemoral Prosthesis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Amputation
Keywords: transtibial
transfemoral
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: iFIT Prosthetics, LLC
name: National Institute on Aging (NIA)
First posted: 2016-09-01
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: single-group pre-post intervention study
Primary purpose: OTHER

Brief summary: iFIT Prosthetics, LLC® created and commercialized a modular, immediate fit, fully adjustable, prosthetic system suitable for mass production using high strength injection molded polymer materials. The aim of this project is to assess the design, user satisfaction and feasibility of this device. The investigators will be fitting transtibial and transfemoral amputees with the iFIT prosthetic system. Patients will wear the device for 2 weeks in order to compare the device to their own prosthetic (if they currently have one). They will report any device breakages or adverse events. They will also fill out a questionnaire to determine if the iFIT prosthetic is a feasible option for treating patients with limb loss.


Eligibility criteria: Inclusion Criteria:

* transtibial or transfemoral level of amputation
* functional ambulator with or without a cane
* six months or more since amputation.

Exclusion Criteria:

* patient have skin ulcerations on the residual limb
* have other central nervous system disorders such as strokes and brain injuries that interfere with safe ambulation and gait testing
* severe phantom or limb pain
* weight over 260 lbs

Primary outcomes:
measure: Prosthetic Comfort and Utility Questionnaire (Version 1)
timeFrame: 2 weeks
measure: Prosthetic Comfort and Utility Questionnaire (Version 2)
timeFrame: 2 weeks
measure: Prosthetic Comfort and Utility Evaluation (Version 3)
timeFrame: 2 weeks
Secondary outcomes:
measure: Number of Participants With Device Related Adverse Events
timeFrame: 2 weeks
measure: Gait Analysis- Walking Speed
timeFrame: two weeks
measure: Internal Socket Pressure
timeFrame: Two weeks
measure: Gait Analysis - Double Support
timeFrame: 2 weeks
measure: Gait Analysis - Limp Index
timeFrame: 2 weeks
measure: Gait Analysis - Stride Length
timeFrame: 2 weeks
measure: Gait Analysis Stance Phase
timeFrame: 2 weeks
measure: Residual Limb Circumference Measurements to Internal Socket Diameter
timeFrame: Same Day
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Penn Medicine Rittenhouse
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Timothy Dillingham, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dillingham T, Kenia J, Shofer F, Marschalek J. A Prospective Assessment of an Adjustable, Immediate Fit, Transtibial Prosthesis. PM R. 2019 Nov;11(11):1210-1217. doi: 10.1002/pmrj.12133. Epub 2019 Apr 1.
citation: McCloskey C, Kenia J, Shofer F, Marschalek J, Dillingham T. Improved Self-Reported Comfort, Stability, and Limb Temperature Regulation with an Immediate Fit, Adjustable Transtibial Prosthesis. Arch Rehabil Res Clin Transl. 2020 Dec;2(4):100090. doi: 10.1016/j.arrct.2020.100090. Epub 2020 Nov 2.
citation: Dillingham TR, Kenia JL, Shofer FS, Marschalek JS. A Prospective Assessment of an Adjustable, Immediate Fit, Subischial Transfemoral Prosthesis. Arch Rehabil Res Clin Transl. 2022 May 2;4(3):100200. doi: 10.1016/j.arrct.2022.100200. eCollection 2022 Sep.