Trial Outcomes & Findings for Peak Plantar Pressures While Wearing a Carbon Fiber Off Loading Orthoses (NCT NCT03618628)
NCT ID: NCT03618628
Last Updated: 2019-05-13
Results Overview
Plantar pressure during walking while the participant wears the brace fabricated based on the finite element (FE) model compared to 1) the brace fabricated based on current clinical standards and 2) barefoot.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
3 participants
Primary outcome timeframe
Participant was tested in new brace (based on FE model) after wearing for 1 week.
Results posted on
2019-05-13
Participant Flow
Participant milestones
| Measure |
People Using a CFO
People who are currently wearing a carbon fiber off loading orthosis (CFO) will have a new CFO fabricated for them based on the results of our finite element (FE) model. We will then test both CFOs ability to reduce peak plantar compared to barefoot and the peak plantarflexor power of both braces.
Carbon Fiber Off Loading Orthosis (CFO): A finite element (FE) model will be created to determine properties that will improve CFO strength while maintaining reduction of peak plantar pressures of the CFO and plantarflexor power. A new CFO will then be fabricated for the participant. Participants will be tested in while walking barefoot, wearing their current CFO, and wearing the FE model driven CFO.
|
|---|---|
|
Overall Study
STARTED
|
3
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
People Using a CFO
People who are currently wearing a carbon fiber off loading orthosis (CFO) will have a new CFO fabricated for them based on the results of our finite element (FE) model. We will then test both CFOs ability to reduce peak plantar compared to barefoot and the peak plantarflexor power of both braces.
Carbon Fiber Off Loading Orthosis (CFO): A finite element (FE) model will be created to determine properties that will improve CFO strength while maintaining reduction of peak plantar pressures of the CFO and plantarflexor power. A new CFO will then be fabricated for the participant. Participants will be tested in while walking barefoot, wearing their current CFO, and wearing the FE model driven CFO.
|
|---|---|
|
Overall Study
Death
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
Baseline Characteristics
Peak Plantar Pressures While Wearing a Carbon Fiber Off Loading Orthoses
Baseline characteristics by cohort
| Measure |
People Using a CFO
n=3 Participants
People who are currently wearing a carbon fiber off loading orthosis (CFO) will have a new CFO fabricated for them based on the results of our finite element (FE) model. We will then test both CFOs ability to reduce peak plantar compared to barefoot and the peak plantarflexor power of both braces.
Carbon Fiber Off Loading Orthosis (CFO): A finite element (FE) model will be created to determine properties that will improve CFO strength while maintaining reduction of peak plantar pressures of the CFO and plantarflexor power. A new CFO will then be fabricated for the participant. Participants will be tested in while walking barefoot, wearing their current CFO, and wearing the FE model driven CFO.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
|
Age, Continuous
|
66.3 years
STANDARD_DEVIATION 11.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Participant was tested in new brace (based on FE model) after wearing for 1 week.Plantar pressure during walking while the participant wears the brace fabricated based on the finite element (FE) model compared to 1) the brace fabricated based on current clinical standards and 2) barefoot.
Outcome measures
| Measure |
People Using a CFO
n=1 Participants
People who are currently wearing a carbon fiber off loading orthosis (CFO) will have a new CFO fabricated for them based on the results of our finite element (FE) model. We will then test both CFOs ability to reduce peak plantar compared to barefoot and the peak plantarflexor power of both braces.
Carbon Fiber Off Loading Orthosis (CFO): A finite element (FE) model will be created to determine properties that will improve CFO strength while maintaining reduction of peak plantar pressures of the CFO and plantarflexor power. A new CFO will then be fabricated for the participant. Participants will be tested in while walking barefoot, wearing their current CFO, and wearing the FE model driven CFO.
|
|---|---|
|
Peak Plantar Pressure
Barefoot (midfoot)
|
75.3 Newtons per squared centimeters
|
|
Peak Plantar Pressure
Current CFO (midfoot)
|
14.2 Newtons per squared centimeters
|
|
Peak Plantar Pressure
Model driven CFO (midfoot)
|
14.5 Newtons per squared centimeters
|
|
Peak Plantar Pressure
Barefoot (Forefoot)
|
22.8 Newtons per squared centimeters
|
|
Peak Plantar Pressure
Current CFO (Forefoot)
|
3.5 Newtons per squared centimeters
|
|
Peak Plantar Pressure
Model driven CFO (Forefoot)
|
6.6 Newtons per squared centimeters
|
|
Peak Plantar Pressure
Barefoot (Heel)
|
60.0 Newtons per squared centimeters
|
|
Peak Plantar Pressure
Current CFO (Heel)
|
23.4 Newtons per squared centimeters
|
|
Peak Plantar Pressure
Model driven CFO (Heel)
|
14.5 Newtons per squared centimeters
|
Adverse Events
People Using a CFO
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Mary Hastings
Washington University School of Medicine
Phone: 3142861433
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place