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NCT Number: NCT07333911

ORLINT & ORLEXT: Orthosis for Knee

The goal of this experimental study is to test the feasibility and validity of a new orthosis in patients with lateral ligament knee lesions of both sexes and older than 18 years old. The main question it aims to answer is:

Is the new orthosis a support for knee stability?? Does the new orthosis improve knee function and patients' quality of life??

The control group will be the subjects themselves when wearing their conventional knee orthosis or without it.

Participants must wear the new knee orthosis for at least one month to assess the effectiveness of the orthosis and evaluate any changes that have occurred in the knee joint and muscles.

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Key information

Conditions

Knee Brace Knee

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Salamanca

Salamanca, 37007, Spain

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patients with chronic knee injuries
  • patients who have already been prescribed an orthosis
  • patients older than 18 years old

Exclusion criteria

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

Treatment and study plan

Orlint-Orlext orthosis device

Device

Participants must wear the new knee orthosis during assessments and in their daily lives for at least one month, which is the duration of the study.

Conventional orthosis device

Device

Participants must wear the conventional knee 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. Knee function with virtual reality

    Time frame: Baseline and up to 4 weeks

    Knee function will be assessed using a virtual reality programme that requires movement of the lower limb to assess knee 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 a 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. It will be measured in degrees (0-120º)

  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 meausure will be the percentaje of support from the sole of the foot.

Study contacts

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

Rocío Llamas-Ramos Dr.

CONTACT

[email protected]

+3465785488

Sponsors and collaborators

Lead sponsor

University of Salamanca

Other

Registry information

Official study title

ORLINT & ORLEXT: New Orthosis for the Lateral Knee Ligaments

Acronym: ORLINT&ORLEXT

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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