Trial Outcomes & Findings for Limb Health and Socket Pressure in Response to Powered Ankle Protheses (NCT NCT05112679)
NCT ID: NCT05112679
Last Updated: 2025-11-12
Results Overview
effects of a powered transtibial prosthesis on the socket pressure for level-ground walking to a microprocessor-controlled prosthesis and a passive prosthesis
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
6 participants
Primary outcome timeframe
4 weeks
Results posted on
2025-11-12
Participant Flow
Participant milestones
| Measure |
Proprio Foot, Then Empower Ankle
Participants started with the PROPRIO FOOT® by Ossur, a microprocessor-controlled prosthesis that regulates the angle of ankle dorsiflexion during the swing phase. After four weeks of use, participants crossed over to use the Empower ankle by Ottobock, an active powered ankle prosthesis, for an additional four weeks.
|
Empower Ankle, Then Proprio Foot
Participants started with the Empower ankle by Ottobock, an active powered ankle prosthesis. After four weeks of use, participants crossed over to use the PROPRIO FOOT® by Ossur, a microprocessor-controlled prosthesis that regulates the angle of ankle dorsiflexion during the swing phase, for an additional four weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
|
Overall Study
COMPLETED
|
3
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Limb Health and Socket Pressure in Response to Powered Ankle Protheses
Baseline characteristics by cohort
| Measure |
Proprio Foot, Then Empower Ankle
n=3 Participants
Participants started with the PROPRIO FOOT® by Ossur, a microprocessor-controlled prosthesis that regulates the angle of ankle dorsiflexion during the swing phase. After four weeks of use, participants crossed over to use the Empower ankle by Ottobock, an active powered ankle prosthesis, for an additional four weeks.
|
Empower Ankle, Then Proprio Foot
n=3 Participants
Participants started with the Empower ankle by Ottobock, an active powered ankle prosthesis. After four weeks of use, participants crossed over to use the PROPRIO FOOT® by Ossur, a microprocessor-controlled prosthesis that regulates the angle of ankle dorsiflexion during the swing phase, for an additional four weeks.
|
Total
n=6 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=10 Participants
|
3 Participants
n=10 Participants
|
6 Participants
n=20 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=10 Participants
|
3 Participants
n=10 Participants
|
6 Participants
n=20 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=20 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=10 Participants
|
3 Participants
n=10 Participants
|
5 Participants
n=20 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
|
Region of Enrollment
United States
|
3 Participants
n=10 Participants
|
3 Participants
n=10 Participants
|
6 Participants
n=20 Participants
|
|
participants completed the study visits
|
3 Participants
n=10 Participants
|
3 Participants
n=10 Participants
|
6 Participants
n=20 Participants
|
PRIMARY outcome
Timeframe: 4 weeksPopulation: accurate in-socket pressure data could be only collected from 3 subjects
effects of a powered transtibial prosthesis on the socket pressure for level-ground walking to a microprocessor-controlled prosthesis and a passive prosthesis
Outcome measures
| Measure |
Proprio Foot
n=3 Participants
Participants who used the PROPRIO FOOT® by Ossur, a microprocessor-controlled prosthesis that regulates the angle of ankle dorsiflexion during the swing phase, for four weeks.
|
Empower Ankle
n=3 Participants
Participants who used the Empower ankle by Ottobock, an active powered ankle prosthesis, for four weeks.
|
|---|---|---|
|
Powered Transtibial Prosthesis on Socket Pressure
|
0.58 kPa/kg
Standard Deviation 0.01
|
0.25 kPa/kg
Standard Deviation 0.03
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: accurate data only from n=4 participants were obtained in Empower foot.
Changes measured with laser speckle imaging. The perfusion data is expressed as perfusion units (PU) which is a dimensionless ratio calculated by dividing the standard deviation of the intensity in a given area by the mean intensity within that area, essentially representing the degree of variation in the speckle pattern. Higher number indicates greater perfusion which is better outcome.
Outcome measures
| Measure |
Proprio Foot
n=6 Participants
Participants who used the PROPRIO FOOT® by Ossur, a microprocessor-controlled prosthesis that regulates the angle of ankle dorsiflexion during the swing phase, for four weeks.
|
Empower Ankle
n=4 Participants
Participants who used the Empower ankle by Ottobock, an active powered ankle prosthesis, for four weeks.
|
|---|---|---|
|
Change in Skin Perfusion
|
1.1 Perfusion Units (PU)
Standard Deviation 0.75
|
0.8 Perfusion Units (PU)
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: 4 weeksWater loss change is measured via the TEWL device- the lower score mean a better outcome for TEWL.
Outcome measures
| Measure |
Proprio Foot
n=6 Participants
Participants who used the PROPRIO FOOT® by Ossur, a microprocessor-controlled prosthesis that regulates the angle of ankle dorsiflexion during the swing phase, for four weeks.
|
Empower Ankle
n=5 Participants
Participants who used the Empower ankle by Ottobock, an active powered ankle prosthesis, for four weeks.
|
|---|---|---|
|
Transepidermal Water Loss (TEWL)
|
2.0 g/m^2 x h
Standard Deviation 0.61
|
0.8 g/m^2 x h
Standard Deviation 0.21
|
Adverse Events
Proprio Foot
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Empower Ankle
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