Knee, Knee Brace
Conditions
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.
Interventions
DEVICEOrlint-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.
DEVICEConventional orthosis device
Participants must wear the conventional knee orthosis and without orthosis, during assessments and before wearing the new one
Sponsors
University of Salamanca
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DEVICE_FEASIBILITY
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Device feasibility | 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
| Measure | Time frame | Description |
|---|---|---|
| Knee function with virtual reality | 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). |
| Range of motion with a Gyko device | 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) |
| Footprint with a pressure platform | 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. |
Countries
Spain
Contacts
CONTACTRocío Llamas-Ramos Dr.
Outcome results
None listed