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Immediate Fit Using Innovative Technology Transtibial Prosthesis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02886936
Recruitment Status : Suspended (COVID 19 is causing us to suspend bringing patients into the hospital for safety reasons.)
First Posted : September 1, 2016
Last Update Posted : May 8, 2020
Sponsor:
Collaborators:
iFIT Prosthetics, LLC
National Institute on Aging (NIA)
Information provided by (Responsible Party):
University of Pennsylvania

Brief Summary:
The goal of iFIT Prosthetics, LLC® was to create and commercialize a modular, immediate fit, fully adjustable, transtibial prosthesis system suitable for mass production using high strength injection molded polymer materials. This goal was achieved and the aim of this project is now to conduct a feasibility and effectiveness study and to assess the design of the device. The investigators will be fitting transtibial amputees that are current prosthesis users with the iFIT device. Patients will wear the device for 2 weeks in order to compare the device to their own. 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.

Condition or disease Intervention/treatment Phase
Amputation Device: iFIT Transtibial Prosthesis Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: single-group pre-post intervention study
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Immediate Fit Using Innovative Technology Transtibial Prosthesis
Actual Study Start Date : May 1, 2018
Estimated Primary Completion Date : May 31, 2020
Estimated Study Completion Date : May 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: iFIT Group
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.




Primary Outcome Measures :
  1. Questionnaire [ Time Frame: 2 weeks ]
    Participants will fill out an evaluation on their current prosthesis, and the iFIT prosthesis after a two week time interval. The questionnaire intends to compare the immediate fit prosthesis to the conventional prosthetic to determine if it is a feasible alternative for persons with limb loss.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • transtibial level of amputation
  • functional ambulator with or without a cane with a well-fitting standard prosthesis on one or both limbs
  • 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 250 lbs

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02886936


Locations
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United States, Pennsylvania
Penn Medicine Rittenhouse
Philadelphia, Pennsylvania, United States, 19146
Sponsors and Collaborators
University of Pennsylvania
iFIT Prosthetics, LLC
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Timothy Dillingham, MD, MS University of Pennsylvania
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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02886936    
Other Study ID Numbers: 815654
2R42AG050430 ( U.S. NIH Grant/Contract )
2SB1AG050430-06 ( U.S. NIH Grant/Contract )
First Posted: September 1, 2016    Key Record Dates
Last Update Posted: May 8, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Pennsylvania:
transtibial amputees