ORLINT & ORLEXT: Orthosis for Knee (ORLINT&ORLEXT)

ORLINT & ORLEXT: New Orthosis for the Lateral Knee Ligaments

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Knee; Knee Brace
• Intervention / Treatment: Device: Orlint-Orlext orthosis device; Device: Conventional orthosis device

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

Contacts and Locations

• Study Contact: Name: Rocío Llamas-Ramos Dr.; Phone Number: +3465785488; Email: rociollamas@usal.es

Study Locations

• Spain
  • Salamanca
    • Salamanca, Salamanca, Spain, 37007
      • University of Salamanca

Participation Criteria

Eligibility Criteria

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

Description

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

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: Orlint-Orlext orthosis group; 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.	Device: Orlint-Orlext orthosis 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.
Active Comparator: Conventional orthesis group; Participants must wear the conventional knee orthosis (a without orthosis) during assessments and in their daily lives, before wear the new one.	Device: Conventional orthosis device; Participants must wear the conventional knee 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
Knee function with virtual reality	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).	Baseline and up to 4 weeks
Range of motion with a Gyko device	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)	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 meausure will be the percentaje of support from the sole of the foot.	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: ORLINT&ORLEXT2026; 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