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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 ankle lesions (external popliteal sciatic nerve or nerve injuries resulting in loss of ankle dorsiflexion) of both sexes and all ages. The main question it aims to answer is:Is the new orthosis a support for ankle stability??Does the new orthosis improve ankle function and patients' quality of life??The control group will be the subjects themselves when wearing their conventional ankle orthosis or without it. Participants must wear the new ankle orthosis for at least one month to assess the effectiveness of the orthosis and evaluate any changes that have occurred in the ankle joint and muscles.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EQUISOCK group | Experimental | Participants must wear the new ankle orthosis during assessments and in their daily lives for at least one month, which is the duration of the study. |
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| Other ankle orthosis | Active Comparator | Participants must wear the conventional ankle orthosis (and 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 |
|---|---|---|---|---|
| EQUISOCK | Device | Participants must wear the new ankle orthosis during assessments and in their daily lives for at least one month, which is the duration of the study. |
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| 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 |
|---|---|---|
| Ankle function with virtual reality | Ankle function will be assessed using a virtual reality programme that requires movement of the lower limb to assess ankle 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 | |
|---|---|---|---|---|
| Rocio Llamas-Ramos Dr. | Contact | +34657854188 | 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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| Other ankle orthosis | Device | Participants must wear the conventional ankle orthosis and without orthosis, during assessments and before wearing the new one |
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| Range of motion with Gyko device | The range of motion of the knee joint will be measured using the Gyko device with and without the new orthosis. The assessment will be in degrees (from 0 to 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 assessment will be the percentage of support from the sole of the foot in each movement. | Baseline and up to 4 weeks |