EQUISOCK: New Antiequine for Ankle
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- University of Salamanca
- Enrollment
- 4
- Locations
- 1
- Primary Endpoint
- Device Feasibility
Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Device Feasibility
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •inability to stand actively and stably
- •inability to walk unaided
- •inability to follow instructions
Arms & Interventions
EQUISOCK group
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.
Intervention: EQUISOCK (Device)
Other ankle orthosis
Participants must wear the conventional ankle orthosis (and without orthosis) during assessments and in their daily lives, before wear the new one.
Intervention: Other ankle orthosis (Device)
Outcomes
Primary Outcomes
Device Feasibility
Time Frame: Baseline and up to 4 weeks
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
Secondary Outcomes
- Footprint with a pressure platform(Baseline and up to 4 weeks)
- Ankle function with virtual reality(Baseline and up to 4 weeks)
- Range of motion with Gyko device(Baseline and up to 4 weeks)
Investigators
Rocío Llamas-Ramos
Principal Investigator
University of Salamanca