Trial Outcomes & Findings for What is the Optimal Stiffness and Height of a Running-specific Prosthesis? (NCT NCT02318979)
NCT ID: NCT02318979
Last Updated: 2019-07-30
Results Overview
The investigators will measure stance average vertical ground reaction forces during running and sprinting.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
30 participants
Primary outcome timeframe
4-10 days
Results posted on
2019-07-30
Participant Flow
Participant milestones
| Measure |
Running
Participants will run on an instrumented treadmill at one speed using different prostheses.
Participants will run using the Otto Bock, Ossur and Freedom Innovations prostheses at a recommended stiffness and height, one category stiffer than recommended at the recommended height, one category softter than recommended at the recommended height, at the optimal stiffness and 2 cm taller, and at the optimal stiffness and 2 cm shorter.
|
Sprinting
Participants will run on an instrumented treadmill at a range of speeds from a jogging speed up to top speed using different prostheses.
Participants will run using the Otto Bock, Ossur and Freedom Innovations prostheses at a recommended stiffness and height, one category stiffer than recommended at the recommended height, one category softter than recommended at the recommended height, at the optimal stiffness and 2 cm taller, and at the optimal stiffness and 2 cm shorter.
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
|
Overall Study
COMPLETED
|
15
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
What is the Optimal Stiffness and Height of a Running-specific Prosthesis?
Baseline characteristics by cohort
| Measure |
Running
n=15 Participants
Participants will run on an instrumented treadmill at one speed using different prostheses.
Participants will run using the Otto Bock, Ossur and Freedom Innovations prostheses at a recommended stiffness and height, one category stiffer than recommended at the recommended height, one category softter than recommended at the recommended height, at the optimal stiffness and 2 cm taller, and at the optimal stiffness and 2 cm shorter.
|
Sprinting
n=15 Participants
Participants will run on an instrumented treadmill at a range of speeds from a jogging speed up to top speed using different prostheses.
Participants will run using the Otto Bock, Ossur and Freedom Innovations prostheses at a recommended stiffness and height, one category stiffer than recommended at the recommended height, one category softter than recommended at the recommended height, at the optimal stiffness and 2 cm taller, and at the optimal stiffness and 2 cm shorter.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
33.4 years
STANDARD_DEVIATION 6.1 • n=5 Participants
|
28 years
STANDARD_DEVIATION 5 • n=7 Participants
|
30 years
STANDARD_DEVIATION 6.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Height
|
1.77 m
STANDARD_DEVIATION 0.08 • n=5 Participants
|
1.77 m
STANDARD_DEVIATION 0.12 • n=7 Participants
|
1.77 m
STANDARD_DEVIATION 0.12 • n=5 Participants
|
|
Weight
|
76.1 kg
STANDARD_DEVIATION 14.1 • n=5 Participants
|
76 kg
STANDARD_DEVIATION 12.4 • n=7 Participants
|
76.1 kg
STANDARD_DEVIATION 14.1 • n=5 Participants
|
PRIMARY outcome
Timeframe: 4-10 daysPopulation: We hypothesized that prosthetic configurations would affect stance average vertical ground reaction forces.
The investigators will measure stance average vertical ground reaction forces during running and sprinting.
Outcome measures
| Measure |
Running
n=15 Participants
Participants will run on an instrumented treadmill at one speed using different prostheses.
Participants will run using the Otto Bock, Ossur and Freedom Innovations prostheses at a recommended stiffness and height, one category stiffer than recommended at the recommended height, one category softter than recommended at the recommended height, at the optimal stiffness and 2 cm taller, and at the optimal stiffness and 2 cm shorter.
|
Sprinting
n=15 Participants
Participants will run on an instrumented treadmill at a range of speeds from a jogging speed up to top speed using different prostheses.
Participants will run using the Otto Bock, Ossur and Freedom Innovations prostheses at a recommended stiffness and height, one category stiffer than recommended at the recommended height, one category softter than recommended at the recommended height, at the optimal stiffness and 2 cm taller, and at the optimal stiffness and 2 cm shorter.
|
|---|---|---|
|
Biomechanics
|
0.1386 N/kg
Standard Deviation 0.0031
|
0.1835 N/kg
Standard Deviation 0.0204
|
SECONDARY outcome
Timeframe: 4 daysPopulation: Best metabolic cost for a running-specific prosthetic configuration.
The investigators will measure rates of oxygen consumption and carbon dioxide production during running to determine the optimal prosthesis for each participant.
Outcome measures
| Measure |
Running
n=10 Participants
Participants will run on an instrumented treadmill at one speed using different prostheses.
Participants will run using the Otto Bock, Ossur and Freedom Innovations prostheses at a recommended stiffness and height, one category stiffer than recommended at the recommended height, one category softter than recommended at the recommended height, at the optimal stiffness and 2 cm taller, and at the optimal stiffness and 2 cm shorter.
|
Sprinting
n=5 Participants
Participants will run on an instrumented treadmill at a range of speeds from a jogging speed up to top speed using different prostheses.
Participants will run using the Otto Bock, Ossur and Freedom Innovations prostheses at a recommended stiffness and height, one category stiffer than recommended at the recommended height, one category softter than recommended at the recommended height, at the optimal stiffness and 2 cm taller, and at the optimal stiffness and 2 cm shorter.
|
|---|---|---|
|
Metabolic Demand
|
3.82 Net CoT (J/kg/m)
Standard Error 1.5
|
3.38 Net CoT (J/kg/m)
Standard Error 1.0
|
SECONDARY outcome
Timeframe: 4-10 daysPopulation: Fastest top speed for a running-specific prosthetic configuration.
The investigators will measure the top sprinting speed to determine the optimal prosthesis for each participant.
Outcome measures
| Measure |
Running
n=10 Participants
Participants will run on an instrumented treadmill at one speed using different prostheses.
Participants will run using the Otto Bock, Ossur and Freedom Innovations prostheses at a recommended stiffness and height, one category stiffer than recommended at the recommended height, one category softter than recommended at the recommended height, at the optimal stiffness and 2 cm taller, and at the optimal stiffness and 2 cm shorter.
|
Sprinting
n=5 Participants
Participants will run on an instrumented treadmill at a range of speeds from a jogging speed up to top speed using different prostheses.
Participants will run using the Otto Bock, Ossur and Freedom Innovations prostheses at a recommended stiffness and height, one category stiffer than recommended at the recommended height, one category softter than recommended at the recommended height, at the optimal stiffness and 2 cm taller, and at the optimal stiffness and 2 cm shorter.
|
|---|---|---|
|
Top Speed
|
8.18 m/s
Standard Deviation 1.00
|
9.42 m/s
Standard Deviation 0.90
|
Adverse Events
Running
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sprinting
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
Judith Jung, DRI Executive Director
Denver Research Institute
Phone: 303-501-0540
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place