Immediate Fit Using Innovative Technology Transtibial & Transfemoral Prosthesis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Amputation
- Sponsor
- University of Pennsylvania
- Enrollment
- 71
- Locations
- 1
- Primary Endpoint
- Prosthetic Comfort and Utility Questionnaire (Version 1)
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
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.
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.
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.
Secondary Outcomes
- Number of Participants With Device Related Adverse Events(2 weeks)
- Residual Limb Circumference Measurements to Internal Socket Diameter(Same Day)
- Gait Analysis - Limp Index(2 weeks)
- Gait Analysis - Stride Length(2 weeks)
- Gait Analysis Stance Phase(2 weeks)
- Gait Analysis- Walking Speed(two weeks)
- Gait Analysis - Double Support(2 weeks)
- Internal Socket Pressure(Two weeks)