Immediate Fit Using Innovative Technology Transtibial & Transfemoral Prosthesis

Study Overview
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Brief Summary
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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.

Official Title
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Immediate Fit Using Innovative Technology Transtibial & Transfemoral Prosthesis

Conditions
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Amputation

Intervention / Treatment
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* Device: iFIT Transtibial Prosthesis
* Device: iFIT Transfemoral Prosthesis


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: single-group pre-post intervention study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transtibial Testing<br>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<br>* 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.<br>|
| Experimental: Transfemoral Testing<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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transtibial, transfemoral