An interventional study of Physioterapy rehabilitation with IVR and standard physiotherapy rehabilitation in Arthroplasty, Replacement, Knee, sponsored by University of Malaga. Status unknown at 1 site in Spain. Open to participants aged 60 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-06-11.
Sponsored by University of Malaga · Not applicable, Interventional, and Treatment
The number of knee arthroplasties performed each year is constantly increasing. Although the outcome is generally favourable, 10-20% do not achieve a satisfactory clinical result. This study evaluates the effectiveness of immersive virtual reality rehabilitation in older people who have undergone knee arthroplasty surgery. The 6 Meter Walking Test is used to determine the improvement of patients after the procedure.
University of Malaga is the lead sponsor of 118 studies on the registry; 34 are open to participants now.
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Exclusion Criteria:
This program includes: static bicycle with virtual reality glasses, analytical lower limb exercises, global lower limb exerciseswith virtual reality glasses and activities to be done at home.
Other: standard physiotherapy rehabilitation
static bicycle, analytical lower limb exercises, global lower limb exercises and activities to be done at home.
Other: Physioterapy rehabilitation with IVR
This program includes: static bicycle with virtual reality glasses, analytical lower limb exercises, global lower limb exerciseswith virtual reality glasses and activities to be done at home.
static bicycle, analytical lower limb exercises, global lower limb exercises and activities to be done at home. This group will perform only five minutes of virtual reality play, but will not use their lower limbs. This way, the results of rehabilitation will not be affected and therapists and patients will be blinded.
Changes in six meter walking test (6-MWT) score
Six-meter walking test is a a well-established outcome measure in a variety of diseases. It is accurate, reproducible, simple to administer, and well tolerated. The 6MWT is a robust assessment tool for use in clinical trials given its ability to quantitatively evaluate ambulation in a controlled environment. Participants will be asked to do quick laps in a flat corridor for 6 minutes with the verbal stimulus provided by the assessor at the end of each lap. A significant improvement threshold after surgery could be between 26 and 55m
Time frame: Baseline, up to three an six months.
Sit to Stand Test
Sit to Stand Test is a simple test to evaluate lower limb muscle strength and balance ability. This test measures the time it takes to sit down completely and get up 5 times with arms crossed over the chest and using a standard height chair (46cm).
Time frame: Baseline, up to three an six months.
The range of motion
The range of motion (ROM) of knee flexion and extension measured with a goniometer.
Time frame: Baseline, up to three an six months.
The Oxford Knee Score (OKS)
The Oxford Knee Score (OKS) is a specific measurement for assessing knee function and condition. It consists of 12 patient-reported questions that measure pain and function after knee arthroplasty surgery. Each question is scored from 0 to 4 with 4 being the best result, producing overall scores that range from 0 to 48, 48 being the best result.
Time frame: Baseline, up to three an six months.
The BERG scale
The BERG scale which is a valid and sensitive scale for assessing balance in the elderly. It is based on the performance of 14 common balance tasks, experienced in daily life, which are graded on an ordinal scale of 5 points (0-4) with a maximum score of 56. Higher scores indicate better balance.
Time frame: Baseline, up to three an six months.
The McMaster Western Ontario McMaster Universities Osteoarthritis Index (WOMAC)
The McMaster Western Ontario McMaster Universities Osteoarthritis Index (WOMAC) is a specific questionnaire to assess the treatment effects of osteoarthritis on patients and their health-related quality of life. It is composed of a multidimensional scale with 24 items grouped in three dimensions: pain (5 items), stiffness (2 items) and physical function (17 items). They are answered by a Likert-type scale with 5 levels of response representing different degrees of intensity (none, mild, moderate, severe, extreme) scoring from 0 to 4. The final score is the sum of the scores of each item. The higher the score, the worse the patient's condition. The data are standardized on a range of 0 (best health condition) to 100 (worst possible condition).
Time frame: Baseline, up to three an six months.
The User Satisfaction Evaluation Questionnaire
The User Satisfaction Evaluation Questionnaire (USEQ) is a questionnaire to evaluate the satisfaction and ease of use of virtual rehabilitation systems. It includes, with a 5-point Likert scale, 6 questions which we can see in Annex 4. The total score ranges from 6 (low satisfaction) to 30 (excellent satisfaction).
Time frame: up to six months
Plan to share: No
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University of Malaga