AmputationNCT02886936
Immediate Fit Using Innovative Technology Transtibial & Transfemoral Prosthesis
A study testing iFIT Transtibial Prosthesis and iFIT Transfemoral Prosthesis in people with Amputation, run by University of Pennsylvania at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amputation
- What is being tested?
- iFIT Transtibial Prosthesis and iFIT Transfemoral Prosthesis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2018to 31 May 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- transtibial or transfemoral level of amputation
- functional ambulator with or without a cane
- six months or more since amputation.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn Medicine Rittenhouse
Philadelphia, Pennsylvania, 19146
About this study
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
- Being tested
- iFIT Transtibial Prosthesis, iFIT Transfemoral Prosthesis
- Keywords
- transtibial, transfemoral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iFIT Transtibial ProsthesisDevice
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 ProsthesisDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: iFIT Transfemoral Prosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 2 weeks
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Same Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2016 (estimated)
- Study start1 May 2018
- Primary completion31 May 2022
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AmputationStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- single-group pre-post intervention study
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- iFIT Prosthetics, LLC, National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Timothy Dillingham, MD, MS, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02886936
- Sponsor's protocol ID
- 815654
- Other IDs
- 2R42AG050430, 2SB1AG050430-06
- Status last verified
- May 2023
- First submitted
- 29 Aug 2016
- Last updated
- 26 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 30734517McCloskey 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.
PubMed 33381750Dillingham 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.
PubMed 36123976
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Fit Using Innovative Technology Transtibial & Transfemoral Prosthesis
- ClinicalTrials.gov ID
- NCT02886936
- Acronym / sponsor ID
- 815654
- Conditions
- Amputation
- Keywords
- transtibial, transfemoral
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- iFIT Prosthetics, LLC, National Institute on Aging (NIA)
- Study start
- 1 May 2018 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 1 Sep 2016 (estimated)
- Results
- Posted 26 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- single-group pre-post intervention study
| Arm | Type | Receives |
|---|---|---|
| Transtibial Testing | Experimental | Device: iFIT Transtibial ProsthesisThis 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. |
| Transfemoral Testing | Experimental | Device: iFIT Transfemoral ProsthesisThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- transtibial or transfemoral level of amputation
- functional ambulator with or without a cane
- six months or more since amputation.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iFIT Transtibial ProsthesisTranstibial 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. | Device | Transtibial Testing |
| iFIT Transfemoral ProsthesisTransfemoral 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. | Device | Transfemoral Testing |
Primary outcome
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.
8 secondary outcomes
Number of Participants With Device Related Adverse Events
Time frame: 2 weeks
Gait Analysis- Walking Speed
Time frame: two weeks
Internal Socket Pressure
Time frame: Two weeks
Gait Analysis - Double Support
Time frame: 2 weeks
Gait Analysis - Limp Index
Time frame: 2 weeks
Gait Analysis - Stride Length
Time frame: 2 weeks
Gait Analysis Stance Phase
Time frame: 2 weeks
Residual Limb Circumference Measurements to Internal Socket Diameter
Time frame: Same Day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 30734517Dillingham 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.
- Results publication: PubMed 33381750McCloskey 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.
- Results publication: PubMed 36123976Dillingham 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Timothy Dillingham, MD, MS principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iFIT Transtibial Prosthesis and iFIT Transfemoral Prosthesis in people with Amputation, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prosthetic Comfort and Utility Questionnaire (Version 1) (time frame: 2 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02886936, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2023.