ORLINT & ORLEXT: Orthosis for Knee

NCT07333911 | Not Yet Recruiting

• 2 other identifiers: ORLINT&ORLEXT2026University 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 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.

Conditions

Knee Brace; Knee

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)

• Knee function with virtual reality

  Baseline and up to 4 weeks

• Range of motion with a Gyko device

  Baseline and up to 4 weeks

• Footprint with a pressure platform

  Baseline and up to 4 weeks

Study Arms (2)

Orlint-Orlext orthosis group

EXPERIMENTAL

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

Conventional orthesis group

ACTIVE COMPARATOR

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

Interventions

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.

Orlint-Orlext orthosis group

Conventional orthosis device DEVICE

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

Conventional orthesis group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Salamanca: lead

Study Sites (1)

University of Salamanca

Salamanca, Salamanca, 37007, Spain

Location

Central Study Contacts

Rocío Llamas-Ramos Dr.

CONTACT

+3465785488; 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)