Immediate Fit Using Innovative Technology Transtibial & Transfemoral Prosthesis
- Conditions
- Amputation
- Interventions
- Device: iFIT Transfemoral ProsthesisDevice: iFIT Transtibial Prosthesis
- Registration Number
- NCT02886936
- Lead Sponsor
- University of Pennsylvania
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 71
- transtibial or transfemoral level of amputation
- functional ambulator with or without a cane
- six months or more since amputation.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Transfemoral Testing iFIT Transfemoral Prosthesis 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. Transtibial Testing iFIT Transtibial Prosthesis 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.
- Primary Outcome Measures
Name Time Method Prosthetic Comfort and Utility Questionnaire (Version 1) 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.Prosthetic Comfort and Utility Questionnaire (Version 2) 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.Prosthetic Comfort and Utility Evaluation (Version 3) 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.
- Secondary Outcome Measures
Name Time Method Number of Participants With Device Related Adverse Events 2 weeks We will record any unfavorable events such that occur including: skin irritation, skin breakdown, falls, or mechanical failures.
Residual Limb Circumference Measurements to Internal Socket Diameter 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.
Gait Analysis - Limp Index 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.
Gait Analysis - Stride Length 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.
Gait Analysis Stance Phase 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.
Gait Analysis- Walking Speed two weeks Gait speed is the time one takes to walk a specified distance on level surfaces over a short distance.
Gait Analysis - Double Support 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.
Internal Socket Pressure 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.
Trial Locations
- Locations (1)
Penn Medicine Rittenhouse
🇺🇸Philadelphia, Pennsylvania, United States