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| Name | Class |
|---|---|
| Stevens Institute of Technology | OTHER |
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The purpose of this research study is to assess the ease, convenience, and efficacy of walking when using a motor powered ankle foot orthosis (AFO) brace, in adults who have had a lower limb injury.
The long-term goal of this project is to improve the outcomes of robot-assisted exercise interventions for patients with reconstructed lower limb following high-energy lower extremity traumas using novel machine learning methods to enable individualized ankle foot orthosis (AFO) designs and self-adaptive AFO assistance.
The main hypothesis predicts greater comfort and lower pain levels when using the new AFO as well as improvements in gait mechanics, which will outperform those induced by patients' daily-use AFOs. The main goal is this adaptive assistance will encourage the wearer's active engagement in RAGT thereby promoting patient self-efficacy/satisfaction and leading to improvements in ambulation after a 6-week rehabilitation program.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adults with lower limb injury | Experimental | All enrolled subjects will be asked to complete the intervention. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Utilization of motorized orthosis | Device | While part of this study, participants will be fitted for the motorized orthosis and will complete walking tests with and without the AFO. |
| Measure | Description | Time Frame |
|---|---|---|
| 10MWT (Aim 1) | 10 meter walk test to evaluate walking speed after lower limb injury and in response to the intervention. Walking evaluated without versus with the motorized orthosis. | Measured before and after 6 week intervention to assess change from baseline. |
| TUG (Aim 1) | Timed up and go (TUG) test to measure functional balance and walking ability after lower limb injury and in response to the intervention. Walking evaluated without versus with the motorized orthosis. | Measured before and after 6 week intervention to assess change from baseline. |
| 6MWT (Aim 1) | 6 minute walking test to evaluate endurance after lower limb injury and in response to the intervention. Walking evaluated without versus with the motorized orthosis. | Measured before and after 6 week intervention to assess change from baseline. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kate Goworek | Contact | 973-324-3560 | 3560 | kgoworek@kesslerfoundation.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kessler Foundation | Recruiting | West Orange | New Jersey | 07052 | United States |
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| ID | Term |
|---|---|
| D007869 | Leg Injuries |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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