18 and older, any sex, with Amputation. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Prosthetic Comfort and Utility Questionnaire (Version 1)Primary· 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.
Conventional Prosthesis
Group
Value
95% CI
Transtibial Testing Study 1
25.52
± 6.8
iFIT Prosthesis
Group
Value
95% CI
Transtibial Testing Study 1
29.33
± 4.51
Prosthetic Comfort and Utility Questionnaire (Version 2)Primary· 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.
iFIT Prosthesis
Group
Value
95% CI
Transtibial Testing Study 2 (Follow Up)
29
± 4.5
Conventional Prosthesis
Group
Value
95% CI
Transtibial Testing Study 2 (Follow Up)
25.4
± 6.8
Prosthetic Comfort and Utility Evaluation (Version 3)Primary· 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.
iFIT Prosthesis
Group
Value
95% CI
Transfemoral Testing
40.9
± 7.2
Conventional Prosthesis
Group
Value
95% CI
Transfemoral Testing
32.8
± 10.2
Number of Participants With Device Related Adverse EventsSecondary· 2 weeks
We will record any unfavorable events such that occur including: skin irritation, skin breakdown, falls, or mechanical failures.
Group
Value
95% CI
Transtibial Testing Study 1
0
Transtibial Testing Study 2 (Follow Up)
0
Transfemoral Testing
0
Transtibial Testing Study 1
2
Transtibial Testing Study 2 (Follow Up)
0
Transfemoral Testing
0
Transtibial Testing Study 1
20
Transtibial Testing Study 2 (Follow Up)
24
Transfemoral Testing
18
Gait Analysis- Walking SpeedSecondary· two weeks
Gait speed is the time one takes to walk a specified distance on level surfaces over a short distance.
Walking Speed Prosthetic Side - iFIT
Group
Value
95% CI
Transtibial Testing Study 1
.98
.98 – 1
Walking Speed Prosthetic Side - Conventional
Group
Value
95% CI
Transtibial Testing Study 1
.98
.97 – 1
Walking Speed Sound Side- iFIT
Group
Value
95% CI
Transtibial Testing Study 1
.98
.97 – 1
Walking Speed Sound Side - Conventional
Group
Value
95% CI
Transtibial Testing Study 1
.98
.97 – 1
Internal Socket PressureSecondary· 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.
iFIT Overall Avg Pressure
Group
Value
95% CI
Transtibial Testing Study 1
17.3
± 2.3
Conventional Overall Avg Pressure
Group
Value
95% CI
Transtibial Testing Study 1
19.3
± 3.7
iFIT Tibial Avg Pressure
Group
Value
95% CI
Transtibial Testing Study 1
18
± 4.2
Conventional Tibial Avg Pressure
Group
Value
95% CI
Transtibial Testing Study 1
22
± 3.7
iFIT Medial Avg Pressure
Group
Value
95% CI
Transtibial Testing Study 1
15.5
± 2.6
Conventional Medial Avg Pressure
Group
Value
95% CI
Transtibial Testing Study 1
16.3
± 5.5
iFIT Posterior Avg Pressure
Group
Value
95% CI
Transtibial Testing Study 1
16.5
± 3.6
Conventional Posterior Avg Pressure
Group
Value
95% CI
Transtibial Testing Study 1
18.1
± 7.5
Gait Analysis - Double SupportSecondary· 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.
Double Support Prosthetic Side- iFIT
Group
Value
95% CI
Transtibial Testing Study 1
.37
.36 – .38
Double Support Prosthetic Side - Conventional
Group
Value
95% CI
Transtibial Testing Study 1
.36
.34 – .36
Double Support Sound Side- iFIT
Group
Value
95% CI
Transtibial Testing Study 1
.37
.37 – .38
Double Support Sound Side- Conventional
Group
Value
95% CI
Transtibial Testing Study 1
.35
.34 – .36
Gait Analysis - Limp IndexSecondary· 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.
Limp Index Prosthetic Side - iFIT
Group
Value
95% CI
Transtibial Testing Study 1
.99
.96 – 1
Limp Index Prosthetic Side- Conventional
Group
Value
95% CI
Transtibial Testing Study 1
.97
.95 – 1
Limp Index Sound Side- iFIT
Group
Value
95% CI
Transtibial Testing Study 1
1.01
1 – 1.04
Limp Index Sound Side - Conventional
Group
Value
95% CI
Transtibial Testing Study 1
1.03
1.01 – 1.05
Gait Analysis - Stride LengthSecondary· 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.
Stride Length Prosthetic Side - iFIT
Group
Value
95% CI
Transtibial Testing Study 1
1.22
1.21 – 1.25
Stride Length Prosthetic Side - Conventional
Group
Value
95% CI
Transtibial Testing Study 1
1.22
1.21 – 1.24
Stride Length Sound Side - iFIT
Group
Value
95% CI
Transtibial Testing Study 1
1.22
1.21 – 1.25
Stride Length Sounds Side - Conventional
Group
Value
95% CI
Transtibial Testing Study 1
1.21
1.20 – 1.24
Gait Analysis Stance PhaseSecondary· 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.
Stance Phase- Prosthetic Side iFIT Avg
Group
Value
95% CI
Transtibial Testing Study 1
64.3
63.3 – 64.6
Stance Phase- Prosthetic Side Conventional Avg
Group
Value
95% CI
Transtibial Testing Study 1
63.4
62.4 – 63.7
Stance Phase- Sound Side iFIT Avg
Group
Value
95% CI
Transtibial Testing Study 1
65.2
64.6 – 65.9
Stance Phase - Sound Side Conventional Avg
Group
Value
95% CI
Transtibial Testing Study 1
65
64.3 – 65.6
Residual Limb Circumference Measurements to Internal Socket DiameterSecondary· 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.
Avg Circumference No Liner Proximal 1/3
Group
Value
95% CI
Transfemoral Testing
51.7
± 7.2
Avg Circumference No Liner Mid Point
Group
Value
95% CI
Transfemoral Testing
47.2
± 7.7
Avg Circumference No Liner Distal 1/3
Group
Value
95% CI
Transfemoral Testing
40.6
± 7
Avg Circumference WITH Liner Proximal 1/3
Group
Value
95% CI
Transfemoral Testing
53.6
± 7.2
Avg Circumference WITH Liner Mid Point
Group
Value
95% CI
Transfemoral Testing
47.7
± 6.1
Avg Circumference WITH Liner Distal 1/3
Group
Value
95% CI
Transfemoral Testing
41.3
± 5.9
Avg Internal Socket Circumference Proximal 1/3
Group
Value
95% CI
Transfemoral Testing
46.3
± 5.3
Avg Internal Socket Circumference Mid Point
Group
Value
95% CI
Transfemoral Testing
40.5
± 4.9
Adverse events — posted to ClinicalTrials.gov
Time frame: 2 weeks.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Pennsylvania
Last refreshed: 26 June 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02886936.