ORLINT & ORLEXT: Orthosis for Knee
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Salamanca
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
patients with chronic knee injuries
patients who have already been prescribed an orthosis
patients older than 18 years old
Disqualifiers
inability to stand actively and stably
inability to walk unaided
Trial design
Design model
Crossover
Treatments tested in this trial
Orlint-Orlext orthosis device
DeviceParticipants 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
DeviceParticipants must wear the conventional knee orthosis and without orthosis, during assessments and before wearing the new one
Treatment groups
4 Participants
are divided into 2 treatment groupsGroup A: Orlint-Orlext orthosis groupExperimental treatment 1 intervention
Group B: Conventional orthesis groupActive comparator 1 intervention
Trial outcomes
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
Time frame
Baseline and up to 4 weeksSecondary outcomes
1
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).
Time frame
Baseline and up to 4 weeks2
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)
Time frame
Baseline and up to 4 weeks3
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.
Time frame
Baseline and up to 4 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: