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| Name | Class |
|---|---|
| College Park Industries | UNKNOWN |
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sidekick Stubbies | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sidekick Stubbies | Device |
|
| 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) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bakery Square MSPO labs | Pittsburgh | Pennsylvania | 15206 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sequential Change of Intervention | Conventional Stubby prostheses and Sidekicks prostheses were used in a randomized sequence |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sidekicks |
| |||||||||||||
| Conventional Prostheses |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sequential Change of Interventions | Conventional Stubby prostheses will be used in this intervention |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Number | m/s | 2 times throughout study completion (every 1 hour during the 2 hour protocol) |
|
1 day
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Stubbies | Control intervention | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Goeran Fiedler | University of Pittsburgh | 4126246475 | gfiedler@pitt.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 27, 2016 | Mar 19, 2018 | SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 27, 2016 | Mar 26, 2018 | ICF_001.pdf |
| Prot | Yes | No | No | Study Protocol | Sep 27, 2016 | May 23, 2018 | Prot_003.pdf |
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| 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) |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 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. | Posted | Mean | Standard Deviation | s | 6 times throughout study completion (3 every 1 hour during the 2 hour protocol) |
|
|
|
| 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. | Posted | Mean | Standard Deviation | ratio | 2 times throughout study completion (every 1 hour during the 2 hour protocol) |
|
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| 1 |
| 0 |
| 1 |
| 0 |
| 1 |
| EG001 | Sidekicks | active intervention | 0 | 1 | 0 | 1 | 0 | 1 |
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