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Completed

NCT Number: NCT02886936

Immediate Fit Using Innovative Technology Transtibial & Transfemoral Prosthesis

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Penn Medicine Rittenhouse

Philadelphia, Pennsylvania, 19146, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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

  1. 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.

  2. Gait Analysis- Walking Speed

    Time frame: two weeks

    Gait speed is the time one takes to walk a specified distance on level surfaces over a short distance.

  3. Internal Socket Pressure

    Time frame: 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.

  4. Gait Analysis - Double Support

    Time frame: 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.

  5. Gait Analysis - Limp Index

    Time frame: 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.

  6. Gait Analysis - Stride Length

    Time frame: 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.

  7. Gait Analysis Stance Phase

    Time frame: 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.

  8. Residual Limb Circumference Measurements to Internal Socket Diameter

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • National Institute on Aging (NIA)
  • iFIT Prosthetics, LLC

Registry information

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Sep 1, 2016
Registry last updated
Jun 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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