Amputation Stumps
Conditions
Brief summary
The purpose of this study is to compare the College Park Sidekicks to conventional stubby prosthetics to investigate their effects on bilateral above-knee-amputee gait velocity, exertion, and balance. The investigators aim to demonstrate that: (i) greater balance will be observed and reported on a level and gravel surface with the Sidekicks; (ii) time to complete the 10-meter walk test will be decreased wearing Sidekicks compared to the conventional stubby prosthesis; and (iii) subjects will report feeling less exerted with the sidekicks.
Interventions
DEVICESidekick Stubbies
Sponsors
College Park Industries
Angela DeCandia
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* bilateral transfemoral amputee * own a pair of conventional stubby prosthesis with standard adaptation
Exclusion criteria
* dependence on assistive walking device or wheelchair (may use devices occasionally but should be able to ambulate without them) * use of prosthesis that do not allow change of feet with standard adapters * any medical condition that may put an individual in greater risk of injury than normal daily activity.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average Speed for 10 Meter Walk Test | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Timed up and go Test Time | 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. |
| Gait Symmetry Index | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Sequential Change of Interventions Conventional Stubby prostheses will be used in this intervention | 1 |
| Total | 1 |
Baseline characteristics
| Characteristic | Sequential Change of Interventions | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 1 Participants | — |
| Age, Continuous | 41 years STANDARD_DEVIATION 0 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 1 participants | — |
| Sex: Female, Male Female | 0 Participants | — |
| Sex: Female, Male Male | 1 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 1 | 0 / 1 |
| other Total, other adverse events | 0 / 1 | 0 / 1 |
| serious Total, serious adverse events | 0 / 1 | 0 / 1 |
Outcome results
Primary
Average Speed for 10 Meter Walk Test
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.
Time frame: 2 times throughout study completion (every 1 hour during the 2 hour protocol)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Stubbies | Average Speed for 10 Meter Walk Test | 0.57 m/s |
| Sidekicks | Average Speed for 10 Meter Walk Test | 0.53 m/s |
Secondary
Gait Symmetry Index
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.
Time frame: 2 times throughout study completion (every 1 hour during the 2 hour protocol)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stubbies | Gait Symmetry Index | 1.046 ratio | Standard Deviation 0.119 |
| Sidekicks | Gait Symmetry Index | 0.965 ratio | Standard Deviation 0.113 |
Secondary
Timed up and go Test Time
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.
Time frame: 6 times throughout study completion (3 every 1 hour during the 2 hour protocol)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stubbies | Timed up and go Test Time | 0.27 s | Standard Deviation 0.0103 |
| Sidekicks | Timed up and go Test Time | 0.25 s | Standard Deviation 0.0074 |