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NCT Number: NCT07333768

EQUISOCK: New Antiequine

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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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other ankle orthosis

Device

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

Primary outcomes

  1. 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

  1. Ankle function with virtual reality

    Time frame: Baseline and up to 4 weeks

    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).

  2. Range of motion with Gyko device

    Time frame: Baseline and up to 4 weeks

    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)

  3. Footprint with a pressure platform

    Time frame: Baseline and up to 4 weeks

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Rocio Llamas-Ramos Dr.

CONTACT

[email protected]

+34657854188

Sponsors and collaborators

Lead sponsor

University of Salamanca

Other

Registry information

Official study title

EQUISOCK: New Antiequine for Ankle

Acronym: EQUISOCK

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 12, 2026
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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