An interventional study of Virtual Reality and Therapeutic exercise in Knee Osteoarthritis, Task Performance and Analysis and Accidental Falls, sponsored by Universidade da Coruña. Not yet recruiting. Open to participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-17.
Sponsored by Universidade da Coruña · Not applicable, Interventional, and Treatment
The goal of this clinical trial is to learn about knee osteoarthritis, functionality, and risk of falls in community-dwelling adults aged 60 years and older. The main questions it aims to answer are:
Participants will:
Researchers will compare community-dwelling adults aged 60 years and older who execute task based exercises in a virtual environment through virtual reality and community-dwelling adults aged 60 years and older receiving conventional physiotherapy treatment based on therapeutic exercise to see if virtual reality improves knee osteoarthritis symptoms, functionality, and lowers fall risk.
Background
Knee osteoarthritis (OA) is prevalent among older adults, affecting a substantial proportion of this population and being linked to various functional impairments such as joint stiffness, reduced mobility, and chronic pain. More specifically, knee OA is one of the most disabling musculoskeletal conditions worldwide, leading to significant healthcare costs and economic burdens. Several studies have demonstrated a strong association between knee OA and falls in older adults. In particular, it has been observed that knee OA is a significant predictor of multiple falls and is closely related to deficits in balance and gait stability.
To properly understand the close relationship between knee OA and falls, it is crucial to consider motor control dysfunctions associated with joint pain and mechanical alterations, as they are often the primary triggers of falls. Research in this field highlights the importance of directing new studies toward functional tasks, as they represent the essence of motor control. Therefore, the observation and analysis of functional tasks are crucial for examining the motor control of older adults, being 3D motion capture systems the gold standard for the measurement and analysis of human movement.
On the other hand, new technologies such as immersive virtual reality (VR) are gaining recognition and popularity as treatment modalities. This is because they allow users to interact with environments and situations that simulate real life, offering activities tailored to their needs while avoiding the potential risks of the real world. Additionally, it provides an opportunity to repeat exercises, improve performance, and achieve effective learning.
Objectives Several objectives are outlined, as a comprehensive approach involving two different phases will be carried out.
Methods
To explore significant differences between groups, a bivariate statistical analysis will be conducted. The Student's T-test for independent samples will be used for comparing means if the variables under consideration are normal; otherwise, the Mann-Whitney U test will be employed for non-normal variables. The chi-square statistic (X2) with a 95% confidence interval will be applied for the association of qualitative variables. The correlation between quantitative variables will be assessed using the Pearson or Spearman correlation coefficient. A significance level of p \< 0.05 will be considered. Data processing and analysis will be carried out using the statistical package SPSS, version 24.0 for Windows (Armonk, NY: IBM Corp.).
3,292 studies on the registry are indexed under Osteoarthritis, Knee; 623 are open to participants now.
This study's planned enrollment of 110 is above the median of 68 across 2,714 interventional studies indexed under Osteoarthritis, Knee.
Browse Osteoarthritis, Knee studies →Universidade da Coruña is the lead sponsor of 33 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The intervention group will perform immersive virtual reality sessions with interactive activities involving functional movements of the spine and limb region in a virtual environment using Meta Quest 3 goggles.
Device: Virtual Reality
The control group will receive conventional physiotherapy treatment based on therapeutic exercise.
Behavioral: Therapeutic exercise
The intervention group will engage in immersive virtual reality sessions with interactive activities involving functional movements of the spine and limbs in a virtual environment using Meta Quest 3 goggles. The intervention will last for 6 weeks, comprising a total of 12 sessions, with a maximum duration of 30 minutes of virtual reality and 15 minutes of rest (45 minutes in total per session).
The control group will receive conventional therapeutic exercise treatment following the recommendations of the Osteoarthritis Research Society International (OARSI), similar to the exercises performed with VR.
Knee osteoarthritis symptoms
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a self-administered questionnaire with 24 items divided into three subscales: (i) pain while walking, using stairs, in bed, sitting, lying down, and standing; (ii) stiffness after waking up and later in the day; (iii) physical function during activities like using stairs, rising from a seated position, bending, walking, getting in/out of a car, shopping, putting on/taking off socks, and performing household tasks. Items are rated on a 0-4 scale: None (0), Mild (1), Moderate (2), Severe (3), Extreme (4). Scores are summed for each subscale (pain: 0-20, stiffness: 0-8, physical function: 0-68). The total score reflects greater pain, stiffness, and functional limitations with higher values.
Time frame: Baseline and change from baseline at 7th week and at 12th month
Pain Intensity
Visual Analog Scale (VAS) with a score ranging from 0 to 100 millimeters (mm).
Time frame: Baseline and change from baseline at 7th week and at 12th month
Initial positioning
Initial positioning in centimeters (cm) of the spine and limbs through the 3D motion capture system Optitrack, defined as the moment when the orientation angle was 2% greater than the average of the first 20 data points.
Time frame: Baseline and change from baseline at 7th week and at 12th month
Final positioning
Final positioning in centimeters (cm) of the spine and limbs through the 3D motion capture system Optitrack, defined as the moment when the orientation angle was 2% lower than the average of the first 20 data points.
Time frame: Baseline and change from baseline at 7th week and at 12th month
Angular velocity
Angular velocity of the spine and limbs through the 3D motion capture system Optitrack, determined from the slope of calculated linear regressions for the frames identified from the start to the peak of a movement, measured in degrees per second (°/s).
Time frame: Baseline and change from baseline at 7th week and at 12th month
Acceleration
Acceleration of the spine and limbs through the 3D motion capture system Optitrack, defined as the velocity of the spine and limbs change over time in meters per second square (m/s²).
Time frame: Baseline and change from baseline at 7th week and at 12th month
Movement execution time
Movement execution time of the spine and limbs through the 3D motion capture system Optitrack, defined as time in seconds to complete or initiate a task.
Time frame: Baseline and change from baseline at 7th week and at 12th month
Range of joint movement
Range of joint movement of the spine and limbs through the 3D motion capture system Optitrack, defined as the angle in degrees (°) between the initial and final positions of the spine and limb movements; two 3D vectors defined by the markers to calculate the arctangent.
Time frame: Baseline and change from baseline at 7th week and at 12th month
Kinesiophobia
Tampa Scale for Kinesiophobia (TSK): consists of 11 statements indicating from 1 (completely disagree) to 4 (completely agree) about the fear of movement. A score equal to or greater than 34 indicates kinesiophobia.
Time frame: Baseline
Falls history
Through an ad hoc question: Have you had any falls in the last year? How many?
Time frame: Baseline and change from baseline at 12th month
General health status
Short Form 12 health questionnaire (SF-12): the questionnaire consists of 12 items that assess physical and mental health in eight dimensions. It uses Likert-type scales with 3 to 6 points to measure the intensity and frequency of subjects' health. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning. Scores above 50 indicate a better-than-average health-related quality of life, while scores below 50 suggest below-average health. Additionally, it provides a syntax that compares subjects' scores with reference values for the Spanish population (50±10) in the 8 dimensions and the two summary components (physical and mental) obtained from these dimensions.
Time frame: Baseline and change from baseline at 7th week and at 12th month
Date of birth
Date of birth will be collected as day/month/year.
Time frame: Baseline
Gender
Gender will be collected as male or female.
Time frame: Baseline
Height
Height of the individual in meters (m) measured using a stadiometer.
Time frame: Baseline
Weight
Weight of the individual in kilograms (kg) measured using a scale.
Time frame: Baseline
Body mass index (BMI)
Weight and height will be combined to report BMI in kg/m\^2.
Time frame: Baseline
Depressive symptoms
Through the Geriatric Depression Scale (GDS-15), which consists of 15 questions with 2 response options (yes/no). The scale's scoring includes: 0-5: normal; \>5: depression.
Time frame: Baseline and change from baseline at 7th week and at 12th month
Cognitive capacity
Trail Making Test (TMT), which consists of two parts (A and B). It involves connecting letters and numbers as quickly as possible without making mistakes. In Part A, the cutoff point between normal and impaired attention is 75 seconds. In Part B, the cutoff point between normal executive function and impairment is \>180 seconds. The test is considered complete when Part A exceeds 100 seconds and Part B exceeds 300.
Time frame: Baseline and change from baseline at 7th week and at 12th month
Amount and type of medication consumed
Through an ad hoc question: In case of taking medication, what type of medication do you use? How often per day/week?
Time frame: Baseline and change from baseline at 7th week and at 12th month
Existence of comorbidity
Through the Charlson Comorbidity Index. The score on this index includes: 0-1 point: absence of comorbidity; 2 points: low comorbidity; \>3 points: high comorbidity.
Time frame: Baseline
Physical performance and fall risk
4x10 m Fast-Paced Walk Test: This test measures the total time (in seconds) required to walk a 10-meter distance four times as fast as possible without running. Times below 8 seconds indicate excellent functional mobility, times between 8 and 12 seconds reflect adequate mobility with slight limitations, and times exceeding 12 seconds suggest significant functional impairment.
Time frame: Baseline and change from baseline at 7th week and at 12th month
Lower limb strength and function
Stair Climb Test: This test measures the time (in seconds) it takes for a person to ascend and descend a predefined number of steps. Times below 10 seconds indicate good functional capacity, times between 10 and 15 seconds are considered acceptable, while times exceeding 15 seconds suggest reduced functional capacity and possible muscle weakness.
Time frame: Baseline and change from baseline at 7th week and at 12th month
Mobility and balance
Timed Up and Go (TUG) Test: This test measures the time (in seconds) required to stand up from a chair, walk 3 meters, turn around, and return to the chair to sit down again. A result below 10 seconds represents excellent mobility, times between 11 and 20 seconds are considered normal, and times exceeding 20 seconds indicate mobility limitations and a higher risk of falls.
Time frame: Baseline and change from baseline at 7th week and at 12th month
Muscle Strength
30-Second Chair Stand Test: This test measures the number of times a person can stand up from and sit down on a chair within 30 seconds. More than 14 repetitions indicate adequate lower limb muscle strength, between 8 and 14 repetitions reflect moderate strength with potential for improvement, and fewer than 8 repetitions suggest muscle weakness and possible functional limitations.
Time frame: Baseline and change from baseline at 7th week and at 12th month
Aerobic capacity
6 Minutes Walking Test (6MWT): this test measures the total distance covered in 6 minutes at a self-paced speed. Walking more than 500 meters indicates excellent functional capacity, between 400 and 500 meters reflects normal capacity with a slight decline, while distances under 400 meters signal significant physical endurance limitations.
Time frame: Baseline and change from baseline at 7th week and at 12th month
Heart Rate
HR: Measured using a pulse oximeter or smartwatches/fitness trackers. At rest, normal values range from 50 to 100 beats per minute (bpm). A rate over 100 bpm may indicate stress or cardiovascular issues, while values below 50 bpm may reflect good physical conditioning.
Time frame: Baseline and change from baseline at 7th week and at 12th month
Blood Pressure
BP: Measured using a sphygmomanometer. Normal values are below 120/80 mmHg. Values between 120/80 and 139/89 mmHg indicate prehypertension, while readings above 140/90 mmHg suggest hypertension and an increased cardiovascular risk.
Time frame: Baseline and change from baseline at 7th week and at 12th month
Oxygen Saturation
SpO2: Measured using a pulse oximeter. Normal values range from 95% to 100%. Values below this range may indicate insufficient oxygen levels.
Time frame: Baseline and change from baseline at 7th week and at 12th month
Cibersickness
Simulator Sickness Questionnaire (SSQ): assesses symptoms associated with VR use through three subscales (nausea, disorientation, and fatigue) and a total score. A score of 0-20 points reflects a low level of symptoms and adequate tolerance; 21-40 indicates moderate symptoms with mild discomfort; 41-100 points signify a high level of symptoms with noticeable discomfort; and values above 100 represent severe discomfort, requiring an immediate interruption of VR use.
Time frame: Baseline and change from baseline at 7th week and at 12th month
No study locations are listed for this record.
Plan to share: Yes — The data that support the findings of this study will be openly available in Zenodo.
Supporting information: Clinical study report
Time frame: The supporting information will be available in the official repository of the University of A Coruña for an indefinite period of time.
Access criteria: Upon request of access to the authors of the study.
Data sharing details ↗ · www.udc.es
This study is not yet recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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