Immediate Fit Using Innovative Technology Transtibial & Transfemoral Prosthesis

Amputation Clinical Trial

Official title:

Immediate Fit Using Innovative Technology Transtibial & Transfemoral Prosthesis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02886936
• Other study ID #: 815654
• Secondary ID: 2R42AG0504302SB1
• Status: Completed
• Phase: N/A
• Start date: May 1, 2018
• Est. completion date: May 31, 2022

Study information

• Verified date: May 2023
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: May 31, 2022
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Amputation

Intervention

Device:
• iFIT Transtibial Prosthesis
Transtibial amputee volunteers will be fit with the iFIT device and instructed on its use. Patient will wear the iFIT device for a two week time period according to a provided wear schedule. At the end of this time patient will rate it for comfort, stability and ease of use.
• iFIT Transfemoral Prosthesis
Transfemoral amputee volunteers will be fit with the iFIT device and instructed on its use. Patient will wear the iFIT device for a two week time period according to a provided wear schedule. At the end of this time patient will rate it for comfort, stability and ease of use.

Locations

Country	Name	City	State
United States	Penn Medicine Rittenhouse	Philadelphia	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
University of Pennsylvania	iFIT Prosthetics, LLC, National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. — View 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: 10.10 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prosthetic Comfort and Utility Questionnaire (Version 1)	This questionnaire is based off of the Prosthetic Evaluation Questionnaire; it involves questions taken from the original that focus on comfort, satisfaction and utility of a prosthetic socket. We used numeric values from 1 (Poor) through 5 (Excellent) for evaluation.; This version featured seven questions for a total of 35 points possible and the lowest score being 7 (higher scores are better). Scores are reported as total with standard deviations.	2 weeks
Primary	Prosthetic Comfort and Utility Questionnaire (Version 2)	This questionnaire is based off of the Prosthetic Evaluation Questionnaire; it involves questions taken from the original that focus on comfort, satisfaction and utility of a prosthetic socket. We used numeric values from 1 (Poor) through 5 (Excellent) for evaluation.; This version features fourteen questions for a total of 70 points total, with the lowest score being 14. Higher scores are better. Scores are reported as total with standard deviations.	2 weeks
Primary	Prosthetic Comfort and Utility Evaluation (Version 3)	This questionnaire is based off of the Prosthetic Evaluation Questionnaire; it involves questions taken from the original that focus on comfort, satisfaction and utility of a prosthetic socket. We used numeric values from 1 (Poor) through 5 (Excellent) for evaluation.; This version features ten questions for a total of 50 points possible, with the lowest score being 10. Higher scores are better. Scores are reported as total with standard deviations.	2 weeks
Secondary	Number of Participants With Device Related Adverse Events	We will record any unfavorable events such that occur including: skin irritation, skin breakdown, falls, or mechanical failures.	2 weeks
Secondary	Gait Analysis- Walking Speed	Gait speed is the time one takes to walk a specified distance on level surfaces over a short distance.	two weeks
Secondary	Internal Socket Pressure	Fujifilm prescale was placed on five specific places on the outside of the participant's liner. They then ambulated for two minutes. The paper was removed and average pressure was recorded. This was completed for both sockets.	Two weeks
Secondary	Gait Analysis - Double Support	Double support is the amount of time that both feet are touching the ground during walking. A faster gait will correlate with lower values since less time is spent with both feet on the ground; consequently, a slower gait will yield higher values.	2 weeks
Secondary	Gait Analysis - Limp Index	Limp index is a temporal parameter used in gait analysis to describe symmetry when walking. For a symmetric walk, the limp index is exactly one; values significantly higher or lower than 1 denote greater asymmetry. It is calculated by using the total support (single + double) for the current foot divided by the total support for the opposite foot.	2 weeks
Secondary	Gait Analysis - Stride Length	Stride length is the distance between successive points of initial contact of the same foot. Right and left stride lengths are normally equal.	2 weeks
Secondary	Gait Analysis Stance Phase	Begins when the foot first touches the ground and ends when the same foot leaves the ground. Expressed as a percentage of the total gait cycle.	2 weeks
Secondary	Residual Limb Circumference Measurements to Internal Socket Diameter	The subject's residual limb was measured at the proximal 1/3, midpoint and distal 1/3 while wearing their liner and on skin. This was compared to their internal socket circumference.	Same Day