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| ID | Type | Description | Link |
|---|---|---|---|
| ERMI LLC Device | Other Identifier | ERMI LLC |
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| Name | Class |
|---|---|
| Ermi LLC | INDUSTRY |
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The purpose of this study is to determine whether the addition of a home-based high-intensity knee extension stretching device (Ermi Knee Extensionater) to standard postoperative physical therapy improves recovery of full knee extension following ACL reconstruction compared with standard physical therapy alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants Receiving Standard of Care | Active Comparator | Patients will receive standard physical therapy alone: postoperative rehabilitation as per the treating clinician's standard ACL protocol (this may include use of the Knee Extensionater in a clinical setting). |
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| Patient Receiving Ermi Knee Extensionator + Standard of Care | Experimental | Patients will receive the Ermi Knee Extensionater plus standard physical therapy: Standard rehabilitation protocol plus daily home use of the Knee Extensionater for terminal extension stretching. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard Physical Therapy | Behavioral | Routine standard physical therapy for post op knee reconstructive surgery. May include use of knee Extensionator in a clinic setting. |
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| Measure | Description | Time Frame |
|---|---|---|
| Changes in Knee Range of Motion | A goniometer will be used to measure the post operative knee's range of motion an angle or to rotate an object to a precise angular position. | Baseline, 2 weeks, 6 weeks, and 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amit Momaya, MD | Contact | (205) 930-8494 | amomaya@uabmc.edu | |
| Camille Crane | Contact | 303-652-7821 | camillecrane@uabmc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Amit Momaya, MD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35243 | United States |
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| Ermi Knee Extensionater | Device | Standard rehabilitation protocol plus daily home use of the Knee Extensionater for terminal extension stretching. The Ermi device will be distributed to all participants in Arm 2 preoperatively. Stretching protocols will be provided at this time. Following surgery, participants must complete daily home stretching sessions (60 total minutes of end-range stretching per day) starting at postoperative day one. Each stretching session is broken down into 10 minutes of stretching, followed by 10 minutes of rest. This is repeated throughout the day until a total of 60 minutes of stretching is completed. There should be at least one hour between sessions. Stretching sessions will continue until 3 months postop. |
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