Trial Outcomes & Findings for Immediate Fit Using Innovative Technology Transtibial & Transfemoral Prosthesis (NCT NCT02886936)
NCT ID: NCT02886936
Last Updated: 2023-06-26
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
71 participants
Primary outcome timeframe
2 weeks
Results posted on
2023-06-26
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
26
|
27
|
18
|
|
Overall Study
COMPLETED
|
22
|
24
|
18
|
|
Overall Study
NOT COMPLETED
|
4
|
3
|
0
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
3
|
0
|
Baseline Characteristics
Immediate Fit Using Innovative Technology Transtibial & Transfemoral Prosthesis
Baseline characteristics by cohort
| Measure |
Transtibial Testing Study 1
n=26 Participants
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.
|
Transtibial Testing Study 2
n=27 Participants
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.
|
Transfemoral Testing
n=18 Participants
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.
|
Total
n=71 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
22 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
55 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Age, Continuous
|
50 years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
55 years
STANDARD_DEVIATION 13.2 • n=7 Participants
|
59.4 years
STANDARD_DEVIATION 7 • n=5 Participants
|
54.8 years
STANDARD_DEVIATION 10.1 • n=4 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
60 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · White/ not Hispanic
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Hispanic/ Latino
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · African American/Black
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Asian/ Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
26 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
71 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 2 weeksPopulation: Persons completing the two week trial from the first cohort.
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.
Outcome measures
| Measure |
Transtibial Testing Study 1
n=22 Participants
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.
|
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.
|
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.
|
|---|---|---|---|
|
Prosthetic Comfort and Utility Questionnaire (Version 1)
Conventional Prosthesis
|
25.52 score on a scale
Standard Deviation 6.8
|
—
|
—
|
|
Prosthetic Comfort and Utility Questionnaire (Version 1)
iFIT Prosthesis
|
29.33 score on a scale
Standard Deviation 4.51
|
—
|
—
|
PRIMARY outcome
Timeframe: 2 weeksPopulation: Transtibial participants that returned for 2 week follow up in the second cohort of subjects.
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.
Outcome measures
| Measure |
Transtibial Testing Study 1
n=24 Participants
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.
|
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.
|
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.
|
|---|---|---|---|
|
Prosthetic Comfort and Utility Questionnaire (Version 2)
iFIT Prosthesis
|
29 score on a scale
Standard Deviation 4.5
|
—
|
—
|
|
Prosthetic Comfort and Utility Questionnaire (Version 2)
Conventional Prosthesis
|
25.4 score on a scale
Standard Deviation 6.8
|
—
|
—
|
PRIMARY outcome
Timeframe: 2 weeksPopulation: Participants with transfemoral limb loss that completed the two week follow up.
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.
Outcome measures
| Measure |
Transtibial Testing Study 1
n=18 Participants
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.
|
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.
|
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.
|
|---|---|---|---|
|
Prosthetic Comfort and Utility Evaluation (Version 3)
iFIT Prosthesis
|
40.9 score on a scale
Standard Deviation 7.2
|
—
|
—
|
|
Prosthetic Comfort and Utility Evaluation (Version 3)
Conventional Prosthesis
|
32.8 score on a scale
Standard Deviation 10.2
|
—
|
—
|
SECONDARY outcome
Timeframe: 2 weeksPopulation: Participant completing the study
We will record any unfavorable events such that occur including: skin irritation, skin breakdown, falls, or mechanical failures.
Outcome measures
| Measure |
Transtibial Testing Study 1
n=22 Participants
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.
|
Transtibial Testing Study 2 (Follow Up)
n=24 Participants
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.
|
Transfemoral Testing
n=18 Participants
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.
|
|---|---|---|---|
|
Number of Participants With Device Related Adverse Events
Serious adverse event: Fall, device breakage, limb ischemia
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Device Related Adverse Events
Minor adverse event: skin irritation or minor skin breakdown
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Device Related Adverse Events
NO Adverse Events
|
20 Participants
|
24 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: two weeksPopulation: 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.
Gait speed is the time one takes to walk a specified distance on level surfaces over a short distance.
Outcome measures
| Measure |
Transtibial Testing Study 1
n=17 Participants
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.
|
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.
|
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.
|
|---|---|---|---|
|
Gait Analysis- Walking Speed
Walking Speed Prosthetic Side - iFIT
|
.98 m/s
Interval 0.98 to 1.0
|
—
|
—
|
|
Gait Analysis- Walking Speed
Walking Speed Prosthetic Side - Conventional
|
.98 m/s
Interval 0.97 to 1.0
|
—
|
—
|
|
Gait Analysis- Walking Speed
Walking Speed Sound Side- iFIT
|
.98 m/s
Interval 0.97 to 1.0
|
—
|
—
|
|
Gait Analysis- Walking Speed
Walking Speed Sound Side - Conventional
|
.98 m/s
Interval 0.97 to 1.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Two weeksPopulation: This was completed on the first cohort for transtibial testing study 1. Testing was not completed on the second cohort or the transfemoral cohort.
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.
Outcome measures
| Measure |
Transtibial Testing Study 1
n=22 Participants
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.
|
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.
|
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.
|
|---|---|---|---|
|
Internal Socket Pressure
iFIT Overall Avg Pressure
|
17.3 p/si
Standard Deviation 2.3
|
—
|
—
|
|
Internal Socket Pressure
Conventional Overall Avg Pressure
|
19.3 p/si
Standard Deviation 3.7
|
—
|
—
|
|
Internal Socket Pressure
iFIT Tibial Avg Pressure
|
18 p/si
Standard Deviation 4.2
|
—
|
—
|
|
Internal Socket Pressure
Conventional Tibial Avg Pressure
|
22 p/si
Standard Deviation 3.7
|
—
|
—
|
|
Internal Socket Pressure
iFIT Medial Avg Pressure
|
15.5 p/si
Standard Deviation 2.6
|
—
|
—
|
|
Internal Socket Pressure
Conventional Medial Avg Pressure
|
16.3 p/si
Standard Deviation 5.5
|
—
|
—
|
|
Internal Socket Pressure
iFIT Posterior Avg Pressure
|
16.5 p/si
Standard Deviation 3.6
|
—
|
—
|
|
Internal Socket Pressure
Conventional Posterior Avg Pressure
|
18.1 p/si
Standard Deviation 7.5
|
—
|
—
|
|
Internal Socket Pressure
iFIT Bottom Avg Pressure
|
20 p/si
Standard Deviation 3.5
|
—
|
—
|
|
Internal Socket Pressure
Conventional Bottom Avg Pressure
|
20.5 p/si
Standard Deviation 4.1
|
—
|
—
|
|
Internal Socket Pressure
iFIT Lateral Avg Pressure
|
16.5 p/si
Standard Deviation 4.8
|
—
|
—
|
|
Internal Socket Pressure
Conventional Lateral Avg Pressure
|
19.3 p/si
Standard Deviation 4.9
|
—
|
—
|
SECONDARY outcome
Timeframe: 2 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Transtibial Testing Study 1
n=17 Participants
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.
|
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.
|
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.
|
|---|---|---|---|
|
Gait Analysis - Double Support
Double Support Prosthetic Side - Conventional
|
.36 seconds
Interval 0.34 to 0.36
|
—
|
—
|
|
Gait Analysis - Double Support
Double Support Sound Side- iFIT
|
.37 seconds
Interval 0.37 to 0.38
|
—
|
—
|
|
Gait Analysis - Double Support
Double Support Prosthetic Side- iFIT
|
.37 seconds
Interval 0.36 to 0.38
|
—
|
—
|
|
Gait Analysis - Double Support
Double Support Sound Side- Conventional
|
.35 seconds
Interval 0.34 to 0.36
|
—
|
—
|
SECONDARY outcome
Timeframe: 2 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Transtibial Testing Study 1
n=17 Participants
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.
|
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.
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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.
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|---|---|---|---|
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Gait Analysis - Limp Index
Limp Index Sound Side- iFIT
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1.01 Index
Interval 1.0 to 1.04
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—
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—
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Gait Analysis - Limp Index
Limp Index Sound Side - Conventional
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1.03 Index
Interval 1.01 to 1.05
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—
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—
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Gait Analysis - Limp Index
Limp Index Prosthetic Side - iFIT
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.99 Index
Interval 0.96 to 1.0
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—
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—
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Gait Analysis - Limp Index
Limp Index Prosthetic Side- Conventional
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.97 Index
Interval 0.95 to 1.0
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—
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—
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SECONDARY outcome
Timeframe: 2 weeksPopulation: 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.
Stride length is the distance between successive points of initial contact of the same foot. Right and left stride lengths are normally equal.
Outcome measures
| Measure |
Transtibial Testing Study 1
n=17 Participants
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.
|
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.
|
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.
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|---|---|---|---|
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Gait Analysis - Stride Length
Stride Length Prosthetic Side - iFIT
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1.22 meters
Interval 1.21 to 1.25
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—
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—
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Gait Analysis - Stride Length
Stride Length Prosthetic Side - Conventional
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1.22 meters
Interval 1.21 to 1.24
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—
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—
|
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Gait Analysis - Stride Length
Stride Length Sound Side - iFIT
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1.22 meters
Interval 1.21 to 1.25
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—
|
—
|
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Gait Analysis - Stride Length
Stride Length Sounds Side - Conventional
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1.21 meters
Interval 1.2 to 1.24
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—
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—
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SECONDARY outcome
Timeframe: 2 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Transtibial Testing Study 1
n=17 Participants
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.
|
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.
|
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.
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|---|---|---|---|
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Gait Analysis Stance Phase
Stance Phase- Prosthetic Side iFIT Avg
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64.3 Percentage of gait cycle
Interval 63.3 to 64.6
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—
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—
|
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Gait Analysis Stance Phase
Stance Phase- Prosthetic Side Conventional Avg
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63.4 Percentage of gait cycle
Interval 62.4 to 63.7
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—
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—
|
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Gait Analysis Stance Phase
Stance Phase- Sound Side iFIT Avg
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65.2 Percentage of gait cycle
Interval 64.6 to 65.9
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—
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—
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Gait Analysis Stance Phase
Stance Phase - Sound Side Conventional Avg
|
65 Percentage of gait cycle
Interval 64.3 to 65.6
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—
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—
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SECONDARY outcome
Timeframe: Same DayPopulation: Only the transfemoral subjects were analyzed. This outcome measure was added after the transtibial subjects were tested.
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.
Outcome measures
| Measure |
Transtibial Testing Study 1
n=18 Participants
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.
|
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.
|
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.
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|---|---|---|---|
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Residual Limb Circumference Measurements to Internal Socket Diameter
Avg Circumference No Liner Proximal 1/3
|
51.7 cm
Standard Deviation 7.2
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—
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—
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Residual Limb Circumference Measurements to Internal Socket Diameter
Avg Circumference No Liner Mid Point
|
47.2 cm
Standard Deviation 7.7
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—
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—
|
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Residual Limb Circumference Measurements to Internal Socket Diameter
Avg Circumference No Liner Distal 1/3
|
40.6 cm
Standard Deviation 7
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—
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—
|
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Residual Limb Circumference Measurements to Internal Socket Diameter
Avg Circumference WITH Liner Proximal 1/3
|
53.6 cm
Standard Deviation 7.2
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—
|
—
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Residual Limb Circumference Measurements to Internal Socket Diameter
Avg Circumference WITH Liner Mid Point
|
47.7 cm
Standard Deviation 6.1
|
—
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—
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Residual Limb Circumference Measurements to Internal Socket Diameter
Avg Circumference WITH Liner Distal 1/3
|
41.3 cm
Standard Deviation 5.9
|
—
|
—
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Residual Limb Circumference Measurements to Internal Socket Diameter
Avg Internal Socket Circumference Proximal 1/3
|
46.3 cm
Standard Deviation 5.3
|
—
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—
|
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Residual Limb Circumference Measurements to Internal Socket Diameter
Avg Internal Socket Circumference Mid Point
|
40.5 cm
Standard Deviation 4.9
|
—
|
—
|
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Residual Limb Circumference Measurements to Internal Socket Diameter
Avg Internal Socket Circumference Distal 1/3
|
35.7 cm
Standard Deviation 5.6
|
—
|
—
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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
|
—
|
—
|
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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
|
—
|
—
|
|
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
|
—
|
—
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Adverse Events
Transtibial Testing
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Transtibial Testing 2(Follow Up)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Transfemoral Testing
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Transtibial Testing
n=26 participants at risk
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.
|
Transtibial Testing 2(Follow Up)
n=27 participants at risk
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.
|
Transfemoral Testing
n=18 participants at risk
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.
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|---|---|---|---|
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Skin and subcutaneous tissue disorders
Skin Breakdown
|
7.7%
2/26 • Number of events 2 • 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.
|
0.00%
0/27 • 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.
|
0.00%
0/18 • 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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Additional Information
Jessica Kenia, Research Coordinator
University of Pennsylvania
Phone: 215-893-2678
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place