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
|Condition or disease||Intervention/treatment||Phase|
|Amputation||Device: iFIT Transtibial Prosthesis||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||single-group pre-post intervention study|
|Masking:||None (Open Label)|
|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|
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.
- 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.
- 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.
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
|United States, Pennsylvania|
|Penn Medicine Rittenhouse|
|Philadelphia, Pennsylvania, United States, 19146|
|Principal Investigator:||Timothy Dillingham, MD, MS||University of Pennsylvania|