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| ID | Type | Description | Link |
|---|---|---|---|
| CDMRP-OP230030 | Other Grant/Funding Number | DoD - USAMRAA |
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| Name | Class |
|---|---|
| Medical University of South Carolina | OTHER |
| Rancho Los Amigos National Rehabilitation Center | OTHER |
| Hanger Clinic: Prosthetics & Orthotics | OTHER |
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The overall goal of this study is to attain the highest possible health-related quality of life for individuals with lower-limb impairment through a clinical trial examining three different modern carbon fiber ankle-foot orthosis (AFO) treatment options targeting the rehabilitation of individuals post-stroke. To achieve this goal, the investigators will:
Participants will be asked to:
In addition, the subset of individuals participating in goal 2) will also be asked to:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PF-CS-MA | Experimental | Participants will wear each of the three ankle-foot orthosis (AFO) treatment options over three separate four-week periods. In this arm, participants first use the pre-fabricated (PF) AFO, followed by the carbon strut (CS) AFO, and finally the multifunctional articulating (MA) AFO. |
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| PF-MA-CS | Experimental | Participants will wear each of the three ankle-foot orthosis (AFO) treatment options over three separate four-week periods. In this arm, participants first use the pre-fabricated (PF) AFO, followed by the multifunctional articulating (MA) AFO, and finally the carbon strut (CS) AFO. |
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| CS-PF-MA | Experimental | Participants will wear each of the three ankle-foot orthosis (AFO) treatment options over three separate four-week periods. In this arm, participants first use the carbon strut (CS) AFO, followed by the pre-fabricated (PF) AFO, and finally the multifunctional articulating (MA) AFO. |
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| CS-MA-PF | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pre-fabricated (PF) ankle-foot orthosis (AFO) | Device | These pre-manufactured orthoses are customized to fit each patient. These devices can help to distribute weight evenly along the foot, but do not offer much opportunity for adjustment to a patient's specific needs. These AFOs achieve ankle motion through material deflection and lack a single point of articulation. |
| Measure | Description | Time Frame |
|---|---|---|
| Health-related quality of life (HRQoL) | Health-related quality of life (HRQoL) is a framework that considers physical, mental, emotional, and social function when assessing the satisfaction of AFO users with their AFO. | Over the real-world use period (4 weeks) for each AFO |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Richard R Neptune, PhD | Contact | 512-471-0848 | rneptune@mail.utexas.edu | |
| Shelby L Walford, PhD | Contact | shelbywalford@utexas.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rancho Research Institute | Recruiting | Downey | California | 90242 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 7996652 | Background | Wilson IB, Cleary PD. Linking clinical variables with health-related quality of life. A conceptual model of patient outcomes. JAMA. 1995 Jan 4;273(1):59-65. |
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Final research de-identified data generated from this project will be made available to the research community upon request. Data requests may be subject to a signed data user agreement (DUA).
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| Brooks Rehabilitation |
| OTHER |
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Participants will wear each of the three ankle-foot orthosis (AFO) treatment options over three separate four-week periods. In this arm, participants first use the carbon strut (CS) AFO, followed by the multifunctional articulating (MA) AFO, and finally the pre-fabricated (PF) AFO. |
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| MA-PF-CS | Experimental | Participants will wear each of the three ankle-foot orthosis (AFO) treatment options over three separate four-week periods. In this arm, participants first use the multifunctional articulating (MA) AFO, followed by the pre-fabricated (PF) AFO, and finally the carbon strut (CS) AFO. |
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| MA-CS-PF | Experimental | Participants will wear each of the three ankle-foot orthosis (AFO) treatment options over three separate four-week periods. In this arm, participants first use the multifunctional articulating (MA) AFO, followed by the carbon strut (CS) AFO, and finally the pre-fabricated (PF) AFO. |
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| Carbon-strut (CS) ankle-foot orthosis (AFO) | Device | These AFO designs are built from a custom mold of the patient's affected limb for a more individualized fit. It includes a solid ankle design and achieves ankle motion through material deflection and lacks a single point of articulation. |
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| Multifunctional articulating (MA) ankle-foot orthosis (AFO) | Device | These AFO designs are also built from a custom mold of the patient's affected limb, but these orthoses have a true articulation at the ankle to provide controlled ankle movement in a range determined appropriate by the orthotist through gait analysis. |
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| Brooks Rehabilitation | Recruiting | Jacksonville | Florida | 32216 | United States |
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| Medical University of South Carolina | Recruiting | Charleston | South Carolina | 29425 | United States |
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| Hanger Clinic | Recruiting | Houston | Texas | 77025 | United States |
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