Trial Outcomes & Findings for Junior LP Foot - Clinical Investigation Protocol (NCT NCT06156839)
NCT ID: NCT06156839
Last Updated: 2026-06-16
Results Overview
User perception of provided prosthetic foot stiffness. Too soft good Too stiff
Recruitment status
COMPLETED
Target enrollment
13 participants
Primary outcome timeframe
2 hours
Results posted on
2026-06-16
Participant Flow
Recruitment took place between January and March 2024, participants recruited from clinic database.
Participant milestones
| Measure |
Prosthetic Foot - Stiffness Testing
Test prosthetic feet with different stiffness properties.
Prosthetic Foot: Stiffness Testing Procedure:
* Potential subjects identified, fitting inclusion/exclusion criteria, by Principle Investigator (PI).
* Informed consent obtained from participant if applicable, legal guardian or both.
* Subject (legal guardian) signs Informed Consent Form (ICF)
* Subject ambulates on their current prescribed foot for observation - Questions administered, by PI or delegated by PI
* Subject fitted with investigational device, by PI
* Subject ambulates in the investigational device for observation - Questions administered, by PI or delegated by PI
* Subject is fitted back to their prescribed prosthesis, by PI
|
|---|---|
|
Overall Study
STARTED
|
13
|
|
Overall Study
COMPLETED
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Prosthetic Foot - Stiffness Testing
n=13 Participants
Test prosthetic feet with different stiffness properties.
Prosthetic Foot: Stiffness Testing Procedure:
* Potential subjects identified, fitting inclusion/exclusion criteria, by Principle Investigator (PI).
* Informed consent obtained from participant if applicable, legal guardian or both.
* Subject (legal guardian) signs Informed Consent Form (ICF)
* Subject ambulates on their current prescribed foot for observation - Questions administered, by PI or delegated by PI
* Subject fitted with investigational device, by PI
* Subject ambulates in the investigational device for observation - Questions administered, by PI or delegated by PI
* Subject is fitted back to their prescribed prosthesis, by PI
|
|---|---|
|
Age, Categorical
<=18 years
|
12 Participants
n=13 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=13 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=13 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=13 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=13 Participants
|
|
Region of Enrollment
United States
|
13 Participants
n=13 Participants
|
|
Weight
|
38.3 kilogram
STANDARD_DEVIATION 12 • n=13 Participants
|
PRIMARY outcome
Timeframe: 2 hoursUser perception of provided prosthetic foot stiffness. Too soft good Too stiff
Outcome measures
| Measure |
Prosthetic Foot - Stiffness Testing
n=13 Participants
Test prosthetic feet with different stiffness properties.
Prosthetic Foot: Stiffness Testing Procedure:
* Potential subjects identified, fitting inclusion/exclusion criteria, by Principle Investigator (PI).
* Informed consent obtained from participant if applicable, legal guardian or both.
* Subject (legal guardian) signs Informed Consent Form (ICF)
* Subject ambulates on their current prescribed foot for observation - Questions administered, by PI or delegated by PI
* Subject fitted with investigational device, by PI
* Subject ambulates in the investigational device for observation - Questions administered, by PI or delegated by PI
* Subject is fitted back to their prescribed prosthesis, by PI
|
|---|---|
|
Overall Prosthetic Foot Stiffness
More stiff
|
5 participants
|
|
Overall Prosthetic Foot Stiffness
Calculated Stiffness
|
3 participants
|
|
Overall Prosthetic Foot Stiffness
Less stiff
|
5 participants
|
SECONDARY outcome
Timeframe: 2 hoursUser perception of provided prosthetic foot performance.
Outcome measures
| Measure |
Prosthetic Foot - Stiffness Testing
n=13 Participants
Test prosthetic feet with different stiffness properties.
Prosthetic Foot: Stiffness Testing Procedure:
* Potential subjects identified, fitting inclusion/exclusion criteria, by Principle Investigator (PI).
* Informed consent obtained from participant if applicable, legal guardian or both.
* Subject (legal guardian) signs Informed Consent Form (ICF)
* Subject ambulates on their current prescribed foot for observation - Questions administered, by PI or delegated by PI
* Subject fitted with investigational device, by PI
* Subject ambulates in the investigational device for observation - Questions administered, by PI or delegated by PI
* Subject is fitted back to their prescribed prosthesis, by PI
|
|---|---|
|
Overall Prosthetic Foot Performance
Performance of the investigational device preferred
|
10 Participants
|
|
Overall Prosthetic Foot Performance
Performance of the previous device preferred
|
3 Participants
|
Adverse Events
Prosthetic Foot - Stiffness 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
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place