Trial Outcomes & Findings for Innovative Prosthetic Systems for Pediatric Limb Loss to Accommodate Growth (NCT NCT05230004)
NCT ID: NCT05230004
Last Updated: 2026-07-02
Results Overview
12 questions selected from the Prosthetic Evaluation Questionnaire were used to rate the prosthesis on comfort, stability, and utility. The questions featured a rating scale from 1-poor to 5-excellent. The range for scores is 12 to 60 total points. Higher scores are considered better.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
35 participants
Primary outcome timeframe
Phase II: 2 months; Phase I: 1 day (approximately 2-3 hours)
Results posted on
2026-07-02
Participant Flow
Participant milestones
| Measure |
Phase II
Phase II involves a two-month home trial to determine the comfort and utility of an adjustable prosthetic system for children aged 3-18. They will complete several questionnaires on their current device and have internal socket pressures and a gait analysis completed. They will return two months later to complete the same outcome measures on their conventional device.
iFIT prosthesis: An adjustable modular prosthesis that can be fit in a single session. Fully adjustable by wearer.
|
Phase I
Phase I involves developing a final design for an adjustable, immediate fit prosthesis. We will recruit 5-10 participants age 3-12 to complete in-lab testing and evaluation of several designs. This testing will lead to the final product design to be tested in Phase II.
iFIT prosthesis: An adjustable modular prosthesis that can be fit in a single session. Fully adjustable by wearer.
|
|---|---|---|
|
Overall Study
STARTED
|
28
|
7
|
|
Overall Study
COMPLETED
|
15
|
7
|
|
Overall Study
NOT COMPLETED
|
13
|
0
|
Reasons for withdrawal
| Measure |
Phase II
Phase II involves a two-month home trial to determine the comfort and utility of an adjustable prosthetic system for children aged 3-18. They will complete several questionnaires on their current device and have internal socket pressures and a gait analysis completed. They will return two months later to complete the same outcome measures on their conventional device.
iFIT prosthesis: An adjustable modular prosthesis that can be fit in a single session. Fully adjustable by wearer.
|
Phase I
Phase I involves developing a final design for an adjustable, immediate fit prosthesis. We will recruit 5-10 participants age 3-12 to complete in-lab testing and evaluation of several designs. This testing will lead to the final product design to be tested in Phase II.
iFIT prosthesis: An adjustable modular prosthesis that can be fit in a single session. Fully adjustable by wearer.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
11
|
0
|
|
Overall Study
Deemed ineligible by PI
|
2
|
0
|
Baseline Characteristics
Innovative Prosthetic Systems for Pediatric Limb Loss to Accommodate Growth
Baseline characteristics by cohort
| Measure |
Phase II
n=28 Participants
Phase II involves a two month home trial to determine the comfort and utility of an adjustable prosthetic system for children aged 3-18. They will complete several questionnaires on their current device, and have internal socket pressures, and a gait analysis completed. They will return two months later to complete the same outcome measures on their conventional device.
iFIT prosthesis: An adjustable modular prosthesis that can be fit in a single session. Fully adjustable by wearer.
|
Phase I
n=7 Participants
Phase I involves developing a final design for an adjustable, immediate fit prosthesis. This testing will lead to the final product design to be tested in Phase II.
\\
iFIT prosthesis: An adjustable modular prosthesis that can be fit in a single session. Fully adjustable by wearer.
|
Total
n=35 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
11.5 years
STANDARD_DEVIATION 4 • n=20 Participants
|
8.4 years
STANDARD_DEVIATION 1.8 • n=20 Participants
|
11.2 years
STANDARD_DEVIATION 3.9 • n=40 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=20 Participants
|
4 Participants
n=20 Participants
|
18 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
17 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
White
|
16 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
17 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Black
|
7 Participants
n=20 Participants
|
4 Participants
n=20 Participants
|
11 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Asian
|
4 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
6 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
1 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
PRIMARY outcome
Timeframe: Phase II: 2 months; Phase I: 1 day (approximately 2-3 hours)Population: Fifteen returned for follow up in the Phase II group. All of Phase I completed in-lab testing.
12 questions selected from the Prosthetic Evaluation Questionnaire were used to rate the prosthesis on comfort, stability, and utility. The questions featured a rating scale from 1-poor to 5-excellent. The range for scores is 12 to 60 total points. Higher scores are considered better.
Outcome measures
| Measure |
Phase II
n=15 Participants
Phase II involves a two month home trial to determine the comfort and utility of an adjustable prosthetic system for children. They will complete several questionnaires on their current device, as well as have internal socket pressures and a gait analysis completed. They will return two months later to complete the same outcome measures on their conventional device.
iFIT prosthesis: An adjustable modular prosthesis that can be fit in a single session. Fully adjustable by wearer.
|
Phase I
n=7 Participants
Phase I involves developing a final design for an adjustable, immediate fit prosthesis. We will recruit 5-10 participants age 3-12 to complete in-lab testing and evaluation of several designs. This testing will lead to the final product design to be tested in Phase II.
iFIT prosthesis: An adjustable modular prosthesis that can be fit in a single session. Fully adjustable by wearer.
|
|---|---|---|
|
Modified Prosthetic Evaluation Questionnaire
Conventional Prosthesis Rating
|
45.8 score on a scale
Standard Deviation 3.2
|
32.1 score on a scale
Standard Deviation 11.2
|
|
Modified Prosthetic Evaluation Questionnaire
Adjustable (iFIT) Prosthesis Rating
|
42.5 score on a scale
Standard Deviation 8.8
|
40.9 score on a scale
Standard Deviation 5.3
|
PRIMARY outcome
Timeframe: Phase II: 2 months; Phase I: 1 day (approximately 2-3 hours)Population: Analyzed returning subjects' conventional socket versus the adjustable (iFIT) socket.
Fujifilm pressure paper will be taped to the participant's liner on five different locations. They will don their socket and walk for approximately 2 minutes at a self-selected walking speed to assess internal socket pressures. The pressures from the five sites are averaged to obtain one overall peak internal socket pressure.
Outcome measures
| Measure |
Phase II
n=15 Participants
Phase II involves a two month home trial to determine the comfort and utility of an adjustable prosthetic system for children. They will complete several questionnaires on their current device, as well as have internal socket pressures and a gait analysis completed. They will return two months later to complete the same outcome measures on their conventional device.
iFIT prosthesis: An adjustable modular prosthesis that can be fit in a single session. Fully adjustable by wearer.
|
Phase I
Phase I involves developing a final design for an adjustable, immediate fit prosthesis. We will recruit 5-10 participants age 3-12 to complete in-lab testing and evaluation of several designs. This testing will lead to the final product design to be tested in Phase II.
iFIT prosthesis: An adjustable modular prosthesis that can be fit in a single session. Fully adjustable by wearer.
|
|---|---|---|
|
Internal Socket Peak Overall Pressure
Conventional
|
21.36 PSI
Standard Deviation 5.48
|
—
|
|
Internal Socket Peak Overall Pressure
Adjustable (iFIT) Prosthesis
|
20.74 PSI
Standard Deviation 6.58
|
—
|
PRIMARY outcome
Timeframe: Phase II: 2 months; Phase I: 1 day (approximately 2-3 hours)Participants will walk at a self-selected walking speed while being recorded by 3d motional analysis cameras. They will walk across a 10 meter runway six times in their conventional socket and six times in the test socket to determine average walking speed.
Outcome measures
| Measure |
Phase II
n=15 Participants
Phase II involves a two month home trial to determine the comfort and utility of an adjustable prosthetic system for children. They will complete several questionnaires on their current device, as well as have internal socket pressures and a gait analysis completed. They will return two months later to complete the same outcome measures on their conventional device.
iFIT prosthesis: An adjustable modular prosthesis that can be fit in a single session. Fully adjustable by wearer.
|
Phase I
Phase I involves developing a final design for an adjustable, immediate fit prosthesis. We will recruit 5-10 participants age 3-12 to complete in-lab testing and evaluation of several designs. This testing will lead to the final product design to be tested in Phase II.
iFIT prosthesis: An adjustable modular prosthesis that can be fit in a single session. Fully adjustable by wearer.
|
|---|---|---|
|
Average Gait Speed
Conventional Prosthesis
|
1.04 mph
Standard Deviation .2
|
—
|
|
Average Gait Speed
Adjustable (iFIT) Prosthesis
|
0.98 mph
Standard Deviation .27
|
—
|
Adverse Events
Phase I
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Phase II
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place