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| ID | Type | Description | Link |
|---|---|---|---|
| University of Salamanca | Other Grant/Funding Number | University of Salamanca |
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The goal of this experimental study is to test the feasibility and validity of a new orthosis in patients with lateral ligament knee lesions of both sexes and older than 18 years old. The main question it aims to answer is:
Is the new orthosis a support for knee stability?? Does the new orthosis improve knee function and patients' quality of life??
The control group will be the subjects themselves when wearing their conventional knee orthosis or without it.
Participants must wear the new knee orthosis for at least one month to assess the effectiveness of the orthosis and evaluate any changes that have occurred in the knee joint and muscles.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Orlint-Orlext orthosis group | Experimental | Participants must wear the new knee orthosis during assessments and in their daily lives for at least one month, which is the duration of the study. |
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| Conventional orthesis group | Active Comparator | Participants must wear the conventional knee orthosis (a without orthosis) during assessments and in their daily lives, before wear the new one. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Orlint-Orlext orthosis device | Device | Participants must wear the new knee orthosis during assessments and in their daily lives for at least one month, which is the duration of the study. |
| Measure | Description | Time Frame |
|---|---|---|
| Device feasibility | Device feasibility will be assessed through participants' awareness of the device, as an indicator of its accessibility, visibility, and potential for effective implementation within the target population. A self-diary will be requested | Baseline and up to 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Knee function with virtual reality | Knee function will be assessed using a virtual reality programme that requires movement of the lower limb to assess knee stability, with and without orthosis. The assessment will be using a Borg scale (range of effort that the individual perceives when exercising). From 0 points (minimum effort) to 10 points (maximum effort). | Baseline and up to 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rocรญo Llamas-Ramos Dr. | Contact | +3465785488 | rociollamas@usal.es |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Salamanca | Salamanca | Salamanca | 37007 | Spain |
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| Conventional orthosis device | Device | Participants must wear the conventional knee orthosis and without orthosis, during assessments and before wearing the new one |
|
| Range of motion with a Gyko device | The range of motion of the knee joint will be measured using the Gyko device with and without the new orthosis. It will be measured in degrees (0-120ยบ) | Baseline and up to 4 weeks |
| Footprint with a pressure platform | The distribution of static and dynamic load will be assessed with and without orthosis, using a pressure platform, as well as static balance with eyes open and closed and dynamic balance. The meausure will be the percentaje of support from the sole of the foot. | Baseline and up to 4 weeks |