Amputation
Conditions
Keywords
transtibial, transfemoral
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.
Interventions
DEVICEiFIT 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.
DEVICEiFIT 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.
Sponsors
iFIT Prosthetics, LLC
National Institute on Aging (NIA)
University of Pennsylvania
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
single-group pre-post intervention study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prosthetic Comfort and Utility Questionnaire (Version 1) | 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) | 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) | 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
| Measure | Time frame | Description |
|---|---|---|
| Gait Analysis - Double Support | 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. |
| Gait Analysis - Limp Index | 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. |
| Number of Participants With Device Related Adverse Events | 2 weeks | We will record any unfavorable events such that occur including: skin irritation, skin breakdown, falls, or mechanical failures. |
| Gait Analysis Stance Phase | 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. |
| Residual Limb Circumference Measurements to Internal Socket Diameter | 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. |
| Gait Analysis - Stride Length | 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. |
| Gait Analysis- Walking Speed | two weeks | Gait speed is the time one takes to walk a specified distance on level surfaces over a short distance. |
| Internal Socket Pressure | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 26 |
| 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. | 27 |
| 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. | 18 |
| Total | 71 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 4 | 3 | 0 |
Baseline characteristics
| Characteristic | Transtibial Testing Study 1 | Transtibial Testing Study 2 | Transfemoral Testing | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 4 Participants | 6 Participants | 6 Participants | 16 Participants |
| Age, Categorical Between 18 and 65 years | 22 Participants | 21 Participants | 12 Participants | 55 Participants |
| Age, Continuous | 50 years STANDARD_DEVIATION 10.2 | 55 years STANDARD_DEVIATION 13.2 | 59.4 years STANDARD_DEVIATION 7 | 54.8 years STANDARD_DEVIATION 10.1 |
| Race/Ethnicity, Customized Race/Ethnicity African American/Black | 14 Participants | 13 Participants | 6 Participants | 33 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Asian/ Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Hispanic/ Latino | 0 Participants | 3 Participants | 2 Participants | 5 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Other | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race/Ethnicity White/ not Hispanic | 12 Participants | 11 Participants | 10 Participants | 33 Participants |
| Region of Enrollment United States | 26 Participants | 27 Participants | 18 Participants | 71 Participants |
| Sex: Female, Male Female | 4 Participants | 5 Participants | 2 Participants | 11 Participants |
| Sex: Female, Male Male | 22 Participants | 22 Participants | 16 Participants | 60 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 26 | 0 / 27 | 0 / 18 |
| other Total, other adverse events | 2 / 26 | 0 / 27 | 0 / 18 |
| serious Total, serious adverse events | 0 / 26 | 0 / 27 | 0 / 18 |
Outcome results
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.
Time frame: 2 weeks
Population: Participants with transfemoral limb loss that completed the two week follow up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Transtibial Testing Study 1 | Prosthetic Comfort and Utility Evaluation (Version 3) | iFIT Prosthesis | 40.9 score on a scale | Standard Deviation 7.2 |
| Transtibial Testing Study 1 | Prosthetic Comfort and Utility Evaluation (Version 3) | Conventional Prosthesis | 32.8 score on a scale | Standard Deviation 10.2 |
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.
Time frame: 2 weeks
Population: Persons completing the two week trial from the first cohort.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Transtibial Testing Study 1 | Prosthetic Comfort and Utility Questionnaire (Version 1) | Conventional Prosthesis | 25.52 score on a scale | Standard Deviation 6.8 |
| Transtibial Testing Study 1 | Prosthetic Comfort and Utility Questionnaire (Version 1) | iFIT Prosthesis | 29.33 score on a scale | Standard Deviation 4.51 |
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.
Time frame: 2 weeks
Population: Transtibial participants that returned for 2 week follow up in the second cohort of subjects.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Transtibial Testing Study 1 | Prosthetic Comfort and Utility Questionnaire (Version 2) | iFIT Prosthesis | 29 score on a scale | Standard Deviation 4.5 |
| Transtibial Testing Study 1 | Prosthetic Comfort and Utility Questionnaire (Version 2) | Conventional Prosthesis | 25.4 score on a scale | Standard Deviation 6.8 |
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.
Time frame: 2 weeks
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Transtibial Testing Study 1 | Gait Analysis - Double Support | Double Support Prosthetic Side- iFIT | .37 seconds |
| Transtibial Testing Study 1 | Gait Analysis - Double Support | Double Support Prosthetic Side - Conventional | .36 seconds |
| Transtibial Testing Study 1 | Gait Analysis - Double Support | Double Support Sound Side- iFIT | .37 seconds |
| Transtibial Testing Study 1 | Gait Analysis - Double Support | Double Support Sound Side- Conventional | .35 seconds |
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.
Time frame: 2 weeks
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Transtibial Testing Study 1 | Gait Analysis - Limp Index | Limp Index Prosthetic Side - iFIT | .99 Index |
| Transtibial Testing Study 1 | Gait Analysis - Limp Index | Limp Index Sound Side- iFIT | 1.01 Index |
| Transtibial Testing Study 1 | Gait Analysis - Limp Index | Limp Index Prosthetic Side- Conventional | .97 Index |
| Transtibial Testing Study 1 | Gait Analysis - Limp Index | Limp Index Sound Side - Conventional | 1.03 Index |
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.
Time frame: 2 weeks
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Transtibial Testing Study 1 | Gait Analysis Stance Phase | Stance Phase- Prosthetic Side iFIT Avg | 64.3 Percentage of gait cycle |
| Transtibial Testing Study 1 | Gait Analysis Stance Phase | Stance Phase- Prosthetic Side Conventional Avg | 63.4 Percentage of gait cycle |
| Transtibial Testing Study 1 | Gait Analysis Stance Phase | Stance Phase- Sound Side iFIT Avg | 65.2 Percentage of gait cycle |
| Transtibial Testing Study 1 | Gait Analysis Stance Phase | Stance Phase - Sound Side Conventional Avg | 65 Percentage of gait cycle |
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.
Time frame: 2 weeks
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Transtibial Testing Study 1 | Gait Analysis - Stride Length | Stride Length Prosthetic Side - iFIT | 1.22 meters |
| Transtibial Testing Study 1 | Gait Analysis - Stride Length | Stride Length Prosthetic Side - Conventional | 1.22 meters |
| Transtibial Testing Study 1 | Gait Analysis - Stride Length | Stride Length Sound Side - iFIT | 1.22 meters |
| Transtibial Testing Study 1 | Gait Analysis - Stride Length | Stride Length Sounds Side - Conventional | 1.21 meters |
Secondary
Gait Analysis- Walking Speed
Gait speed is the time one takes to walk a specified distance on level surfaces over a short distance.
Time frame: two weeks
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Transtibial Testing Study 1 | Gait Analysis- Walking Speed | Walking Speed Sound Side- iFIT | .98 m/s |
| Transtibial Testing Study 1 | Gait Analysis- Walking Speed | Walking Speed Prosthetic Side - iFIT | .98 m/s |
| Transtibial Testing Study 1 | Gait Analysis- Walking Speed | Walking Speed Prosthetic Side - Conventional | .98 m/s |
| Transtibial Testing Study 1 | Gait Analysis- Walking Speed | Walking Speed Sound Side - Conventional | .98 m/s |
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.
Time frame: Two weeks
Population: This was completed on the first cohort for transtibial testing study 1. Testing was not completed on the second cohort or the transfemoral cohort.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Transtibial Testing Study 1 | Internal Socket Pressure | iFIT Overall Avg Pressure | 17.3 p/si | Standard Deviation 2.3 |
| Transtibial Testing Study 1 | Internal Socket Pressure | Conventional Overall Avg Pressure | 19.3 p/si | Standard Deviation 3.7 |
| Transtibial Testing Study 1 | Internal Socket Pressure | iFIT Tibial Avg Pressure | 18 p/si | Standard Deviation 4.2 |
| Transtibial Testing Study 1 | Internal Socket Pressure | Conventional Tibial Avg Pressure | 22 p/si | Standard Deviation 3.7 |
| Transtibial Testing Study 1 | Internal Socket Pressure | iFIT Medial Avg Pressure | 15.5 p/si | Standard Deviation 2.6 |
| Transtibial Testing Study 1 | Internal Socket Pressure | Conventional Medial Avg Pressure | 16.3 p/si | Standard Deviation 5.5 |
| Transtibial Testing Study 1 | Internal Socket Pressure | iFIT Posterior Avg Pressure | 16.5 p/si | Standard Deviation 3.6 |
| Transtibial Testing Study 1 | Internal Socket Pressure | Conventional Posterior Avg Pressure | 18.1 p/si | Standard Deviation 7.5 |
| Transtibial Testing Study 1 | Internal Socket Pressure | iFIT Bottom Avg Pressure | 20 p/si | Standard Deviation 3.5 |
| Transtibial Testing Study 1 | Internal Socket Pressure | Conventional Bottom Avg Pressure | 20.5 p/si | Standard Deviation 4.1 |
| Transtibial Testing Study 1 | Internal Socket Pressure | iFIT Lateral Avg Pressure | 16.5 p/si | Standard Deviation 4.8 |
| Transtibial Testing Study 1 | Internal Socket Pressure | Conventional Lateral Avg Pressure | 19.3 p/si | Standard Deviation 4.9 |
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.
Time frame: 2 weeks
Population: Participant completing the study
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Transtibial Testing Study 1 | Number of Participants With Device Related Adverse Events | Minor adverse event: skin irritation or minor skin breakdown | 2 Participants |
| Transtibial Testing Study 1 | Number of Participants With Device Related Adverse Events | Serious adverse event: Fall, device breakage, limb ischemia | 0 Participants |
| Transtibial Testing Study 1 | Number of Participants With Device Related Adverse Events | NO Adverse Events | 20 Participants |
| Transtibial Testing Study 2 (Follow Up) | Number of Participants With Device Related Adverse Events | Minor adverse event: skin irritation or minor skin breakdown | 0 Participants |
| Transtibial Testing Study 2 (Follow Up) | Number of Participants With Device Related Adverse Events | Serious adverse event: Fall, device breakage, limb ischemia | 0 Participants |
| Transtibial Testing Study 2 (Follow Up) | Number of Participants With Device Related Adverse Events | NO Adverse Events | 24 Participants |
| Transfemoral Testing | Number of Participants With Device Related Adverse Events | Serious adverse event: Fall, device breakage, limb ischemia | 0 Participants |
| Transfemoral Testing | Number of Participants With Device Related Adverse Events | NO Adverse Events | 18 Participants |
| Transfemoral Testing | Number of Participants With Device Related Adverse Events | Minor adverse event: skin irritation or minor skin breakdown | 0 Participants |
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.
Time frame: Same Day
Population: Only the transfemoral subjects were analyzed. This outcome measure was added after the transtibial subjects were tested.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Transtibial Testing Study 1 | Residual Limb Circumference Measurements to Internal Socket Diameter | Avg Circumference No Liner Proximal 1/3 | 51.7 cm | Standard Deviation 7.2 |
| Transtibial Testing Study 1 | Residual Limb Circumference Measurements to Internal Socket Diameter | Avg Circumference No Liner Mid Point | 47.2 cm | Standard Deviation 7.7 |
| Transtibial Testing Study 1 | Residual Limb Circumference Measurements to Internal Socket Diameter | Avg Circumference No Liner Distal 1/3 | 40.6 cm | Standard Deviation 7 |
| Transtibial Testing Study 1 | Residual Limb Circumference Measurements to Internal Socket Diameter | Avg Circumference WITH Liner Proximal 1/3 | 53.6 cm | Standard Deviation 7.2 |
| Transtibial Testing Study 1 | Residual Limb Circumference Measurements to Internal Socket Diameter | Avg Circumference WITH Liner Mid Point | 47.7 cm | Standard Deviation 6.1 |
| Transtibial Testing Study 1 | Residual Limb Circumference Measurements to Internal Socket Diameter | Avg Circumference WITH Liner Distal 1/3 | 41.3 cm | Standard Deviation 5.9 |
| Transtibial Testing Study 1 | Residual Limb Circumference Measurements to Internal Socket Diameter | Avg Internal Socket Circumference Proximal 1/3 | 46.3 cm | Standard Deviation 5.3 |
| Transtibial Testing Study 1 | Residual Limb Circumference Measurements to Internal Socket Diameter | Avg Internal Socket Circumference Mid Point | 40.5 cm | Standard Deviation 4.9 |
| Transtibial Testing Study 1 | Residual Limb Circumference Measurements to Internal Socket Diameter | Avg Internal Socket Circumference Distal 1/3 | 35.7 cm | Standard Deviation 5.6 |
| Transtibial Testing Study 1 | Residual Limb Circumference Measurements to Internal Socket Diameter | Avg Difference Between Limb and Socket While Wearing Liner Proximal 1/3 | 7.3 cm | Standard Deviation 3.6 |
| Transtibial Testing Study 1 | Residual Limb Circumference Measurements to Internal Socket Diameter | Avg Difference Between Limb and Socket While Wearing Liner Mid Point | 7.2 cm | Standard Deviation 3.9 |
| Transtibial Testing Study 1 | Residual Limb Circumference Measurements to Internal Socket Diameter | Avg Difference Between Limb and Socket While Wearing Liner Distal 1/3 | 5.6 cm | Standard Deviation 4.2 |