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| ID | Type | Description | Link |
|---|---|---|---|
| 2R42AG050430 | U.S. NIH Grant/Contract | View source | |
| 2SB1AG050430-06 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| iFIT Prosthetics, LLC | INDUSTRY |
| National Institute on Aging (NIA) | NIH |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 weeks |
| Gait Analysis- Walking Speed |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Timothy Dillingham, MD, MS | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Penn Medicine Rittenhouse | Philadelphia | Pennsylvania | 19146 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30734517 | Result | 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. | |
| 33381750 | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Transtibial Testing Study 1 | 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. iFIT Transtibial Prosthesis: 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. |
| FG001 | Transtibial Testing Study 2 (Follow Up) | This is a follow up 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. iFIT Transtibial Prosthesis: 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. |
| FG002 | Transfemoral Testing | 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. iFIT Transfemoral Prosthesis: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Transtibial and Transfemoral subjects that enrolled in the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Transtibial Testing Study 1 | 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. iFIT Transtibial Prosthesis: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Persons completing the two week trial from the first cohort. | Posted | Mean | Standard Deviation | score on a scale | 2 weeks |
|
2 weeks
Serious events were recorded during the follow up. They were obtained by visual inspection of the skin and prosthesis, and through verbal report from the participant.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Transtibial Testing | 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. iFIT Transtibial Prosthesis: 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. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin Breakdown | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Skin breakdown |
Participants that entered the study may have been dissatisfied with their current prosthesis.
This research was conducted at a single location.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jessica Kenia, Research Coordinator | University of Pennsylvania | 215-893-2678 | jessica.kenia@pennmedicine.upenn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 13, 2022 | Sep 13, 2022 | Prot_SAP_000.pdf |
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single-group pre-post intervention study
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|
| 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. |
|
Gait speed is the time one takes to walk a specified distance on level surfaces over a short distance.
| 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. | 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. | 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. | 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. | 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. | 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. | Same Day |
| 36123976 | 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. |
| BG001 | Transtibial Testing Study 2 | This is a follow up 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. iFIT Transtibial Prosthesis: 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. |
| BG002 | Transfemoral Testing | 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. iFIT Transfemoral Prosthesis: 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. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| Primary | 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. | Transtibial participants that returned for 2 week follow up in the second cohort of subjects. | Posted | Mean | Standard Deviation | score on a scale | 2 weeks |
|
|
|
| Primary | 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. | Participants with transfemoral limb loss that completed the two week follow up. | Posted | Mean | Standard Deviation | score on a scale | 2 weeks |
|
|
|
| Secondary | 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. | Participant completing the study | Posted | Count of Participants | Participants | 2 weeks |
|
|
|
| Secondary | Gait Analysis- Walking Speed | Gait speed is the time one takes to walk a specified distance on level surfaces over a short distance. | Persons from the first cohort (transtibial testing study 1) that completed the two week trial and had unilateral amputation. Cohort two was not tested. Persons with transfemoral amputation were not tested due to a difference in knees between testing conditions. | Posted | Mean | 95% Confidence Interval | m/s | two weeks |
|
|
|
| Secondary | 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. | This was completed on the first cohort for transtibial testing study 1. Testing was not completed on the second cohort or the transfemoral cohort. | Posted | Mean | Standard Deviation | p/si | Two weeks |
|
|
|
| Secondary | 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. | Persons from the first cohort (transtibial testing study 1) that completed the two week trial and had unilateral amputation. Cohort two was not tested. Persons with transfemoral amputation were not tested due to a difference in knees between testing conditions. | Posted | Mean | 95% Confidence Interval | seconds | 2 weeks |
|
|
|
| Secondary | 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. | Participants from the first cohort (transtibial testing study 1) that completed the two week trial and had unilateral amputation. Persons in cohort two were not tested. Persons for the transfemoral testing were not tested as the componentry (prosthetic knees) were markedly different. | Posted | Mean | 95% Confidence Interval | Index | 2 weeks |
|
|
|
| Secondary | 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. | Persons from the first cohort (transtibial testing study 1) that completed the two week trial and had unilateral amputation. Cohort two was not tested. Persons with transfemoral amputation were not tested due to a difference in knees between testing conditions. | Posted | Mean | 95% Confidence Interval | meters | 2 weeks |
|
|
|
| Secondary | 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. | Persons from the first cohort (transtibial testing study 1) that completed the two week trial and had unilateral amputation. Cohort two was not tested. Persons with transfemoral amputation were not tested due to a difference in knees between testing conditions. | Posted | Number | 95% Confidence Interval | Percentage of gait cycle | 2 weeks |
|
|
|
| Secondary | 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. | Only the transfemoral subjects were analyzed. This outcome measure was added after the transtibial subjects were tested. | Posted | Mean | Standard Deviation | cm | Same Day |
|
|
|
| 0 |
| 26 |
| 0 |
| 26 |
| 2 |
| 26 |
| EG001 | Transtibial Testing 2(Follow Up) | This is a follow up 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. iFIT Transtibial Prosthesis: 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. | 0 | 27 | 0 | 27 | 0 | 27 |
| EG002 | Transfemoral Testing | 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. iFIT Transfemoral Prosthesis: 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. | 0 | 18 | 0 | 18 | 0 | 18 |
|
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|
| NO Adverse Events |
|
|
| Walking Speed Sound Side - Conventional |
|
| Title | Measurements |
|---|---|
|
| Conventional Tibial Avg Pressure |
|
| iFIT Medial Avg Pressure |
|
| Conventional Medial Avg Pressure |
|
| iFIT Posterior Avg Pressure |
|
| Conventional Posterior Avg Pressure |
|
| iFIT Bottom Avg Pressure |
|
| Conventional Bottom Avg Pressure |
|
| iFIT Lateral Avg Pressure |
|
| Conventional Lateral Avg Pressure |
|
|
| Double Support Sound Side- Conventional |
|
|
| Limp Index Sound Side - Conventional |
|
|
| Stride Length Sounds Side - Conventional |
|
|
| Stance Phase - Sound Side Conventional Avg |
|
|
| Avg Circumference WITH Liner Proximal 1/3 |
|
| Avg Circumference WITH Liner Mid Point |
|
| Avg Circumference WITH Liner Distal 1/3 |
|
| Avg Internal Socket Circumference Proximal 1/3 |
|
| Avg Internal Socket Circumference Mid Point |
|
| Avg Internal Socket Circumference Distal 1/3 |
|
| Avg Difference Between Limb and Socket While Wearing Liner Proximal 1/3 |
|
| Avg Difference Between Limb and Socket While Wearing Liner Mid Point |
|
| Avg Difference Between Limb and Socket While Wearing Liner Distal 1/3 |
|