Immediate Fit Using Innovative Technology Transtibial & Transfemoral Prosthesis

NCT02886936 | Completed Results

• 3 other identifiers: 8156542R42AG0504302SB1AG050430-06
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

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.

Conditions

Amputation

Keywords

transtibial; transfemoral

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (8)

• Number of Participants With Device Related Adverse Events

  2 weeks

• Gait Analysis- Walking Speed

  two weeks

• Internal Socket Pressure

  Two weeks

• Gait Analysis - Double Support

  2 weeks

• Gait Analysis - Limp Index

  2 weeks

Study Arms (2)

Transtibial Testing

EXPERIMENTAL

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

Transfemoral Testing

EXPERIMENTAL

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

Interventions

iFIT Transtibial Prosthesis DEVICE

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.

Transtibial Testing

iFIT Transfemoral Prosthesis DEVICE

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.

Transfemoral Testing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• transtibial or transfemoral level of amputation
• functional ambulator with or without a cane
• six months or more since amputation.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead
• iFIT Prosthetics, LLC: collaborator
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Penn Medicine Rittenhouse

Philadelphia, Pennsylvania, 19146, United States

Location

Related Publications (3)

• Dillingham T, Kenia J, Shofer F, Marschalek J. A Prospective Assessment of an Adjustable, Immediate Fit, Transtibial Prosthesis. PM R. 2019 Nov;11(11):1210-1217. doi: 10.1002/pmrj.12133. Epub 2019 Apr 1.

  PMID: 30734517 RESULT

• McCloskey C, Kenia J, Shofer F, Marschalek J, Dillingham T. Improved Self-Reported Comfort, Stability, and Limb Temperature Regulation with an Immediate Fit, Adjustable Transtibial Prosthesis. Arch Rehabil Res Clin Transl. 2020 Dec;2(4):100090. doi: 10.1016/j.arrct.2020.100090. Epub 2020 Nov 2.

  PMID: 33381750 RESULT

• Dillingham TR, Kenia JL, Shofer FS, Marschalek JS. A Prospective Assessment of an Adjustable, Immediate Fit, Subischial Transfemoral Prosthesis. Arch Rehabil Res Clin Transl. 2022 May 2;4(3):100200. doi: 10.1016/j.arrct.2022.100200. eCollection 2022 Sep.

  PMID: 36123976 RESULT

Limitations and Caveats

Participants that entered the study may have been dissatisfied with their current prosthesis. This research was conducted at a single location.

Results Point of Contact

• Title: Jessica Kenia, Research Coordinator
• Organization: University of Pennsylvania

jessica.kenia@pennmedicine.upenn.edu

215-893-2678

Study Officials

• Timothy Dillingham, MD, MS

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: single-group pre-post intervention study

Study Record Dates

• First Submitted: August 29, 2016
• First Posted: September 1, 2016
• Study Start: May 1, 2018
• Primary Completion: May 31, 2022
• Study Completion: May 31, 2022
• Last Updated: June 26, 2023
• Results First Posted: June 26, 2023

Record last verified: 2023-05

Locations

US (1)