EQUISOCK: New Antiequine
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorUniversity of Salamanca
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
patients with chronic ankle injuries
patients with external popliteal sciatic nerve lesion or nerve injuries resulting in loss of ankle dorsiflexion
patients who have already been prescribed an orthosis
patients of all ages
Disqualifiers
inability to stand actively and stably
inability to walk unaided
inability to follow instructions
Trial design
Design model
Crossover
Treatments tested in this trial
EQUISOCK
DeviceParticipants 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.
Other ankle orthosis
DeviceParticipants must wear the conventional ankle orthosis and without orthosis, during assessments and before wearing the new one
Treatment groups
4 Participants
are divided into 2 treatment groupsGroup A: EQUISOCK groupExperimental treatment 1 intervention
Group B: Other ankle orthosisActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
Baseline and up to 4 weeksSecondary outcomes
1
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).
Time frame
Baseline and up to 4 weeks2
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 120º)
Time frame
Baseline and up to 4 weeks3
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.
Time frame
Baseline and up to 4 weeksSponsors and contacts
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Source ClinicalTrials.gov
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