A Comparative Analysis Between College Park Sidekick Feet and Conventional Stubby Prosthesis

Study Overview
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Brief Summary
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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.

Conditions
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Amputation Stumps

Intervention / Treatment
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* Device: Sidekick Stubbies


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sidekick Stubbies<br>Conventional Stubby prostheses were used for baseline measures. In the sequential crossover design, articulated stubby prostheses (Sidekick manufactured by College Park Ind.) were used as intervention | Device: Sidekick Stubbies<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 2 times throughout study completion (every 1 hour during the 2 hour protocol) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 times throughout study completion (3 every 1 hour during the 2 hour protocol) | 
| 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. | 2 times throughout study completion (every 1 hour during the 2 hour protocol) |