EQUISOCK: New Antiequine (EQUISOCK)

EQUISOCK: New Antiequine for Ankle

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 Overview

• Status: Not yet recruiting
• Conditions: Ankle Equinus; Ankle (Ligaments); Instability (Old Injury); Ankle Dorsiflexion
• Intervention / Treatment: Device: EQUISOCK; Device: Other ankle orthosis

• Study Type: Interventional
• Enrollment (Estimated): 4
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rocio Llamas-Ramos Dr.; Phone Number: +34657854188; Email: rociollamas@usal.es

Study Locations

• Spain
  • Salamanca
    • Salamanca, Salamanca, Spain, 37007
      • University of Salamanca
      • Contact: Rocio Llamas-Ramos; Phone Number: +034657854188; Email: rociollamas@usal.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: EQUISOCK; 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.
Active Comparator: 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.	Device: Other ankle orthosis; Participants must wear the conventional ankle orthosis and without orthosis, during assessments and before wearing the new one

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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)	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

Collaborators and Investigators

• Sponsor: University of Salamanca

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: December 8, 2025
• First Submitted That Met QC Criteria: December 31, 2025
• First Posted (Actual): January 12, 2026

Study Record Updates

• Last Update Posted (Actual): April 28, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: EQUISOCK2026; University of Salamanca (Other Grant/Funding Number: University of Salamanca)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No