Immediate Fit Using Innovative Technology Transtibial & Transfemoral Prosthesis

May 31, 2023 updated by: University of Pennsylvania
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

71

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19146
        • Penn Medicine Rittenhouse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Transtibial Testing
This is a feasibility and effectiveness study to assess the iFIT transtibial prosthesis as a viable alternative to a traditional prosthesis. We also hope to gain information that will influence future design iterations.
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.
Experimental: Transfemoral Testing
This is a feasibility and effectiveness study to assess the iFIT transfemoral prosthesis as a viable alternative to a traditional prosthesis. We also hope to gain information that will influence future design iterations.
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prosthetic Comfort and Utility Questionnaire (Version 1)
Time Frame: 2 weeks

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
Prosthetic Comfort and Utility Questionnaire (Version 2)
Time Frame: 2 weeks

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
Prosthetic Comfort and Utility Evaluation (Version 3)
Time Frame: 2 weeks

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Device Related Adverse Events
Time Frame: 2 weeks
We will record any unfavorable events such that occur including: skin irritation, skin breakdown, falls, or mechanical failures.
2 weeks
Gait Analysis- Walking Speed
Time Frame: two weeks
Gait speed is the time one takes to walk a specified distance on level surfaces over a short distance.
two weeks
Internal Socket Pressure
Time Frame: Two weeks
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
Gait Analysis - Double Support
Time Frame: 2 weeks
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
Gait Analysis - Limp Index
Time Frame: 2 weeks
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
Gait Analysis - Stride Length
Time Frame: 2 weeks
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
Gait Analysis Stance Phase
Time Frame: 2 weeks
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
Residual Limb Circumference Measurements to Internal Socket Diameter
Time Frame: Same Day
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pennsylvania

Collaborators

National Institute on Aging (NIA)
iFIT Prosthetics, LLC

Investigators

  • Principal Investigator: Timothy Dillingham, MD, MS, University of Pennsylvania

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2018

Primary Completion (Actual)

May 31, 2022

Study Completion (Actual)

May 31, 2022

Study Registration Dates

First Submitted

August 29, 2016

First Submitted That Met QC Criteria

August 31, 2016

First Posted (Estimated)

September 1, 2016

Study Record Updates

Last Update Posted (Actual)

June 26, 2023

Last Update Submitted That Met QC Criteria

May 31, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 815654
  • 2R42AG050430 (U.S. NIH Grant/Contract)
  • 2SB1AG050430-06 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Amputation

Clinical Trials on iFIT Transtibial Prosthesis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Peru

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe