EQUISOCK: New Antiequine

NCT07333768 | Not Yet Recruiting

• 2 other identifiers: EQUISOCK2026University of Salamanca
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Ankle Equinus; Ankle Dorsiflexion; Ankle (Ligaments); Instability (Old Injury)

Outcome Measures

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

  Baseline and up to 4 weeks

Secondary Outcomes (3)

• Ankle function with virtual reality

  Baseline and up to 4 weeks

• Range of motion with Gyko device

  Baseline and up to 4 weeks

• Footprint with a pressure platform

  Baseline and up to 4 weeks

Study Arms (2)

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.

Device: EQUISOCK

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.

Device: Other ankle orthosis

Interventions

Other ankle orthosis DEVICE

Participants must wear the conventional ankle orthosis and without orthosis, during assessments and before wearing the new one

Other ankle orthosis

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.

EQUISOCK group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• inability to stand actively and stably
• inability to walk unaided
• inability to follow instructions

Sponsors & Collaborators

• University of Salamanca: lead

Study Sites (1)

University of Salamanca

Salamanca, Salamanca, 37007, Spain

Location

Central Study Contacts

Rocio Llamas-Ramos Dr.

CONTACT

+34657854188; rociollamas@usal.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DEVICE FEASIBILITY
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 8, 2025
• First Posted: January 12, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 28, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)