Trial Outcomes & Findings for A Comparative Analysis Between College Park Sidekick Feet and Conventional Stubby Prosthesis (NCT NCT02921295)
NCT ID: NCT02921295
Last Updated: 2018-06-21
Results Overview
The participant is timed while covering a 10-m distance unassisted (running start). The average speed is then calculated for each pass (one with each set of prosthetic feet), using the equation 10m/(recorded time in seconds). The average speed is computed as it is more reliable and representative than the instantaneous gait speed that may not be consistently maintained during the 10-m walk.
COMPLETED
NA
1 participants
2 times throughout study completion (every 1 hour during the 2 hour protocol)
2018-06-21
Participant Flow
Participant milestones
| Measure |
Sequential Change of Intervention
Conventional Stubby prostheses and Sidekicks prostheses were used in a randomized sequence
|
|---|---|
|
Conventional Prostheses
STARTED
|
1
|
|
Conventional Prostheses
COMPLETED
|
1
|
|
Sidekicks
STARTED
|
1
|
|
Sidekicks
COMPLETED
|
1
|
|
Sidekicks
NOT COMPLETED
|
0
|
|
Conventional Prostheses
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 |
Sequential Change of Interventions
n=1 Participants
Conventional Stubby prostheses will be used in this intervention
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=1 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=1 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=1 Participants
|
|
Age, Continuous
|
41 years
STANDARD_DEVIATION 0 • n=1 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=1 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=1 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=1 Participants
|
PRIMARY outcome
Timeframe: 2 times throughout study completion (every 1 hour during the 2 hour protocol)The participant is timed while covering a 10-m distance unassisted (running start). The average speed is then calculated for each pass (one with each set of prosthetic feet), using the equation 10m/(recorded time in seconds). The average speed is computed as it is more reliable and representative than the instantaneous gait speed that may not be consistently maintained during the 10-m walk.
Outcome measures
| Measure |
Stubbies
n=1 Participants
Conventional Stubby prostheses as control intervention in cross-over trial
|
Sidekicks
n=1 Participants
Active intervention in cross-over trial
|
|---|---|---|
|
Average Speed for 10 Meter Walk Test
|
0.57 m/s
|
0.53 m/s
|
SECONDARY outcome
Timeframe: 6 times throughout study completion (3 every 1 hour during the 2 hour protocol)The test, as described in the protocol form, is performed three times with each intervention. This allows averaging to reduce the risk of random errors in timing the exercise. Accordingly, the participant is asked to repeat (with resting breaks in between) the tests three times with the stubbies and three times with the sidekicks.
Outcome measures
| Measure |
Stubbies
n=1 Participants
Conventional Stubby prostheses as control intervention in cross-over trial
|
Sidekicks
n=1 Participants
Active intervention in cross-over trial
|
|---|---|---|
|
Timed up and go Test Time
|
0.27 s
Standard Deviation 0.0103
|
0.25 s
Standard Deviation 0.0074
|
SECONDARY outcome
Timeframe: 2 times throughout study completion (every 1 hour during the 2 hour protocol)Left/Right Step Duration Ratio. Perfect gait symmetry would result in a ratio of 1.000. Any deviation would indicate that step lengths differ between legs, indicating a more or less pronounced limping. The measure is computed from the intermediary step sample of gait with each intervention. This allows averaging to reduce the risk of random errors in assessment. Step samples were extracted from walking trial data with the stubbies and with the sidekicks. Each walking trial contains more than 30 individual steps for analysis.
Outcome measures
| Measure |
Stubbies
n=1 Participants
Conventional Stubby prostheses as control intervention in cross-over trial
|
Sidekicks
n=1 Participants
Active intervention in cross-over trial
|
|---|---|---|
|
Gait Symmetry Index
|
1.046 ratio
Standard Deviation 0.119
|
0.965 ratio
Standard Deviation 0.113
|
Adverse Events
Stubbies
Sidekicks
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