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| Name | Class |
|---|---|
| Össur Iceland ehf | INDUSTRY |
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The purpose of this industry-initiated research study is to test that a powered microprocessor controlled knee improves metabolic function during walking in level and sloped conditions as compared to the subject's physician prescribed prosthesis.
The Procedures include:
Initial Visit:
Second Visit
Third Visit (1 week later)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Powered Microprocessor-controlled Knee (PMPK) | Experimental | the "Power Knee" is a commercially available PMPK. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Powered Microprocessor-controlled Knee (PMPK) | Other | A microprocessor-controlled Knee with standardized commercial prosthetic foot |
|
| Measure | Description | Time Frame |
|---|---|---|
| VO2 uptake - level ground | VO2 uptake during ambulation on a treadmill - level ground | Change between Baseline Visit (study enrollment) and Visit 2 (3 weeks post-study enrollment) |
| VO2 uptake - incline | VO2 uptake during ambulation on a treadmill - 5 degree incline | Visit 2 (3 weeks post-study enrollment) |
| Measure | Description | Time Frame |
|---|---|---|
| Balance confidence | Activities based balance confidence survey (0-100%) higher score means more balance confidence | At Baseline Visit (study enrollment) |
| Exertion | Borg Exertion Scale (0-10) with 10 being maximum exertion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michael Davidson, Ph.D. | Contact | 9095586516 | mdavidson@llu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Michael Davidson, Ph.D. | Loma Linda University Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loma Linda University | Recruiting | Loma Linda | California | 92354 | United States |
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Participants will be their own control
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| Change between Visit 2 (3 weeks post-study enrollment) and Visit 3 (4 weeks post-study enrollment) |