ORLINT & ORLEXT: New Orthosis for the Lateral Knee Ligaments
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- University of Salamanca
- Enrollment
- 4
- Locations
- 1
- Primary Endpoint
- Device feasibility
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Device Feasibility
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Orlint-Orlext orthosis device (Device)
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.
Intervention: Conventional orthosis device (Device)
Outcomes
Primary Outcomes
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
- 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)
Investigators
Rocío Llamas-Ramos
Principal Investigator
University of Salamanca