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This study will look to examine the overall performance of a custom fit knee or ankle brace as a means of providing ankle or knee joint support in subjects that have determined the need for bracing based upon chronic joint instability and/or joint swelling and pain following daily activity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ankle/Knee brace | Experimental | Dr. Scholl's Prototype Ankle or Knee Brace |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dr. Scholl's Prototype Ankle Brace | Device | Subjects will be instructed to wear the assigned Ankle/Knee brace for 8 ± 2 hours per day, for a minimun of 5 days out of a 7-day/1 week wear period. |
| Measure | Description | Time Frame |
|---|---|---|
| Comfort | Comfort is assessed utilizing a 7-point Comfort/Discomfort Likert scale. | Up to 15 days |
| Pain Relief of Knee or Ankle joint | Evaluation of Knee or Ankle joint pain will be performed using the Visual Analog Scale utilizing a 100 mm line defined at each end of the line by 0 = no pain and 100 = Worst pain possible. | Up to 15 days |
| Measure | Description | Time Frame |
|---|---|---|
| Product Fit | Product Fit is assessed utilizing a 7-point scale. | Up to 15 days |
| Product Support | Support is assessed utilizing a 5-point scale. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Colorado Springs | Colorado | 80915 | United States | |||
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| Dr. Scholl's Prototype Knee Brace | Device | Subjects will be instructed to wear the assigned Ankle/Knee brace for 8 ± 2 hours per day, for a minimun of 5 days out of a 7-day/1 week wear period. |
|
| Up to 15 days |
| Freedom of Movement | Freedom of Movement is assessed utilizing a 6-point scale. | Up to 15 days |
| Subjective Questions | Applicable subjective questions will be assessed utilizing the subjective questionnaire. | Up to 15 days |
| Richardson |
| Texas |
| 75081 |
| United States |
| ID | Term |
|---|---|
| D007593 | Joint Instability |
| D010146 | Pain |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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