Knee OsteoarthritisNCT06362785
Knee Osteoarthritis, Motor Control, Risk of Falls and Virtual Reality
A study testing Virtual Reality and Therapeutic exercise in people with Knee Osteoarthritis and Task Performance and Analysis, run by Universidade da Coruña.
Trial summary
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: What are the characteristics of a community-dwelling population over 60 years and older in terms of knee… Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Knee Osteoarthritis, Task Performance and Analysis, Accidental Falls
- What is being tested?
- Virtual Reality and Therapeutic exercise
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2025to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age over 60 years.
- Non-institutionalized individuals.
- Subjects who wish and consent through informed consent to participate in the study.
- Have the ability to walk independently (with or without assistive devices).
- Diagnosis of primary knee osteoarthritis according to the clinical and radiological criteria of the American College of Rheumatology.
- Specifically, for phase 1, subjects without a knee osteoarthritis diagnosis will also be included.
Who cannot join
- History of significant previous traumas or surgeries to the spine, pelvis, or legs in the last 12 months.
- Self-reported presence of dizziness, seizures, or epilepsy, aiming to prevent potential exacerbation of symptoms with VR.
- Vestibular disorders (balance).
- Neurological diseases, cardiovascular, or respiratory disorders affecting activity; as well as inflammatory or autoimmune diseases affecting the lower limb joints, and other forms of secondary osteoarthritis.
- Diagnosis of a terminal illness or a health condition that prevents attendance.
- To have a medical contraindication for exercise.
- Body Mass Index (BMI) ≥ 40
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Study on the Relationship Between Knee Osteoarthritis, Motor Control and the Risk of Falls, and the Effectiveness of Virtual Reality in Managing It in Older People
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:
- What are the characteristics of a community-dwelling population over 60 years and older in terms of knee osteoarthritis, functionality, and risk of falls?
- Does an intervention with virtual reality lower knee osteoarthritis symptoms, raise functionality and prevent falls in community-dwelling adults aged 60 years and older, compared to a control group receiving conventional physiotherapy treatment based on therapeutic exercise?
Read more
Participants will:
- Answer questionnaires.
- Perform physical laboratory tests through a camera-based motion capture system.
- Execute task-based exercises in a virtual environment through virtual reality.
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.
Read the detailed description
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.
- Phase 1 (Cross-Sectional Study) Main objective: to describe the population aged 60 and older living in the community in terms of knee osteoarthritis symptoms, functionality, and fall risk.
- Phase 2 (Experimental Study) Main objective: to assess the efficacy of a virtual reality intervention in a community-dwelling population aged 60 and above in terms of knee osteoarthritis symptoms improvement, functionality improvement, and fall risk reduction.
Methods
- Setting, locations and relevant dates: testing is going to be conducted in the Research Center for Information and Communication Technologies (CITIC) (A Coruña, Spain) and Senior University Center of the University of A Coruña (A Coruña, Spain).
- Data collection is planned for the months of May 2024 to May 2025.
- Participants: the recruitment of participants will be carried out through the dissemination of the study via informative posters distributed in the University of A Coruña, including the Senior University; in the network of civic centers in the city of A Coruña; as well as electronically through the researchers' social media networks (Twitter, Facebook, and Instagram). The participant information process, as well as the request for informed consent, will be conducted in the CITIC, after having answered the pre-selection questionnaires.
- Variables: see "outcomes measures".
- Study size: the sample size is estimated using the G-power program, indicating that the minimum number of participants needed to detect medium effect sizes, with a type I error probability of 0.05 and a power of 0.95, with an effect size of 0.7 and considering the analysis through the t-test: the difference between two independent means would be a total of 110 participants.
- Statistical analysis: a descriptive analysis will be performed to characterize the subjects in detail. Qualitative variables will be presented as absolute figures with their respective percentages, and quantitative variables as measures of central tendency (mean and median) and dispersion (standard deviation, minimum, and maximum values). The Kolmogorov-Smirnov test will be used to assess the normality of data distribution.
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.).
- Being tested
- Virtual Reality, Therapeutic exercise
- Keywords
- Knee osteoarthritis, Task Performance and Analysis, Accidental Falls, Aged, Virtual Reality
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual RealityDevice
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).
Therapeutic exerciseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| virtual reality | Experimental | 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. Receives: Device: Virtual Reality |
| Control | Active comparator | The control group will receive conventional physiotherapy treatment based on therapeutic exercise. Receives: Behavioral: Therapeutic exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Baseline and change from baseline at 7th week and at 12th month
Secondary outcomes (21)
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.
Measured: Baseline
Falls history
Through an ad hoc question: Have you had any falls in the last year? How many?
Measured: 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.
Measured: 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.
Measured: Baseline
Gender
Gender will be collected as male or female.
Measured: Baseline
Height
Height of the individual in meters (m) measured using a stadiometer.
Measured: Baseline
Weight
Weight of the individual in kilograms (kg) measured using a scale.
Measured: Baseline
Body mass index (BMI)
Weight and height will be combined to report BMI in kg/m^2.
Measured: 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.
Measured: 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.
Measured: 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?
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and change from baseline at 7th week and at 12th month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2024
- Study start1 May 2025 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade da Coruña
- Sponsor type
- University, hospital or other
- Collaborators
- Centre for Information and Communications Technology Research (CITIC), Faculty of Physiotherapy
- Responsible party
- Sponsor
- Investigators
- Beatriz Rodríguez-Romero, PhD, Study director, Universidade da Coruña
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06362785
- Sponsor's protocol ID
- Virtual Reality-Seniors
- Status last verified
- Dec 2024
- First submitted
- 26 Mar 2024
- Last updated
- 17 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data that support the findings of this study will be openly available in Zenodo.
Publications
Altenburger P, Ambike SS, Haddad JM. Integrating Motor Variability Evaluation Into Movement System Assessment. Phys Ther. 2023 Oct 3;103(10):pzad075. doi: 10.1093/ptj/pzad075.
PubMed 37364059Quinn L, Riley N, Tyrell CM, Judd DL, Gill-Body KM, Hedman LD, Packel A, Brown DA, Nabar N, Scheets P. A Framework for Movement Analysis of Tasks: Recommendations From the Academy of Neurologic Physical Therapy's Movement System Task Force. Phys Ther. 2021 Sep 1;101(9):pzab154. doi: 10.1093/ptj/pzab154.
PubMed 34160044Benham S, Kang M, Grampurohit N. Immersive Virtual Reality for the Management of Pain in Community-Dwelling Older Adults. OTJR (Thorofare N J). 2019 Apr;39(2):90-96. doi: 10.1177/1539449218817291. Epub 2018 Dec 29.
PubMed 30595096Bannuru RR, Osani MC, Vaysbrot EE, Arden NK, Bennell K, Bierma-Zeinstra SMA, Kraus VB, Lohmander LS, Abbott JH, Bhandari M, Blanco FJ, Espinosa R, Haugen IK, Lin J, Mandl LA, Moilanen E, Nakamura N, Snyder-Mackler L, Trojian T, Underwood M, McAlindon TE. OARSI guidelines for the non-surgical management of knee, hip, and polyarticular osteoarthritis. Osteoarthritis Cartilage. 2019 Nov;27(11):1578-1589. doi: 10.1016/j.joca.2019.06.011. Epub 2019 Jul 3.
PubMed 31278997Stratford PW, Kennedy DM, Woodhouse LJ. Performance measures provide assessments of pain and function in people with advanced osteoarthritis of the hip or knee. Phys Ther. 2006 Nov;86(11):1489-96. doi: 10.2522/ptj.20060002.
PubMed 17079748Tunas-Maceiras I, Pereira J, Pertega Diaz S, Lopez Campos JA, Rodriguez-Romero B. Virtual reality versus conventional exercise for knee osteoarthritis: protocol for a randomised controlled trial on functionality and fall risk. BMJ Open. 2025 Oct 20;15(10):e102776. doi: 10.1136/bmjopen-2025-102776.
PubMed 41120141
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Relationship Between Knee Osteoarthritis, Motor Control and the Risk of Falls, and the Effectiveness of Virtual Reality in Managing It in Older People
- ClinicalTrials.gov ID
- NCT06362785
- Acronym / sponsor ID
- Virtual Reality-Seniors
- Keywords
- Knee osteoarthritis, Task Performance and Analysis, Accidental Falls, Aged, Virtual Reality
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Universidade da CoruñaUniversity, hospital or other
- Collaborators
- Centre for Information and Communications Technology Research (CITIC), Faculty of Physiotherapy
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 12 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- What are the characteristics of a community-dwelling population over 60 years and older in terms of knee osteoarthritis, functionality, and risk of falls?
- Does an intervention with virtual reality lower knee osteoarthritis symptoms, raise functionality and prevent falls in community-dwelling adults aged 60 years and older, compared to a control group receiving conventional physiotherapy treatment based on therapeutic exercise?
Participants will:
- Answer questionnaires.
- Perform physical laboratory tests through a camera-based motion capture system.
- Execute task-based exercises in a virtual environment through virtual reality.
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.
Detailed description
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.
- Phase 1 (Cross-Sectional Study) Main objective: to describe the population aged 60 and older living in the community in terms of knee osteoarthritis symptoms, functionality, and fall risk.
- Phase 2 (Experimental Study) Main objective: to assess the efficacy of a virtual reality intervention in a community-dwelling population aged 60 and above in terms of knee osteoarthritis symptoms improvement, functionality improvement, and fall risk reduction.
Methods
- Setting, locations and relevant dates: testing is going to be conducted in the Research Center for Information and Communication Technologies (CITIC) (A Coruña, Spain) and Senior University Center of the University of A Coruña (A Coruña, Spain).
- Data collection is planned for the months of May 2024 to May 2025.
- Participants: the recruitment of participants will be carried out through the dissemination of the study via informative posters distributed in the University of A Coruña, including the Senior University; in the network of civic centers in the city of A Coruña; as well as electronically through the researchers' social media networks (Twitter, Facebook, and Instagram). The participant information process, as well as the request for informed consent, will be conducted in the CITIC, after having answered the pre-selection questionnaires.
- Variables: see "outcomes measures".
- Study size: the sample size is estimated using the G-power program, indicating that the minimum number of participants needed to detect medium effect sizes, with a type I error probability of 0.05 and a power of 0.95, with an effect size of 0.7 and considering the analysis through the t-test: the difference between two independent means would be a total of 110 participants.
- Statistical analysis: a descriptive analysis will be performed to characterize the subjects in detail. Qualitative variables will be presented as absolute figures with their respective percentages, and quantitative variables as measures of central tendency (mean and median) and dispersion (standard deviation, minimum, and maximum values). The Kolmogorov-Smirnov test will be used to assess the normality of data distribution.
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.).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| virtual reality | Experimental | Device: Virtual RealityThe 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. |
| Control | Active comparator | Behavioral: Therapeutic exerciseThe control group will receive conventional physiotherapy treatment based on therapeutic exercise. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age over 60 years.
- Non-institutionalized individuals.
- Subjects who wish and consent through informed consent to participate in the study.
- Have the ability to walk independently (with or without assistive devices).
- Diagnosis of primary knee osteoarthritis according to the clinical and radiological criteria of the American College of Rheumatology.
Key exclusion criteria (7 listed)
- History of significant previous traumas or surgeries to the spine, pelvis, or legs in the last 12 months.
- Self-reported presence of dizziness, seizures, or epilepsy, aiming to prevent potential exacerbation of symptoms with VR.
- Vestibular disorders (balance).
- Neurological diseases, cardiovascular, or respiratory disorders affecting activity; as well as inflammatory or autoimmune diseases affecting the lower limb joints, and other forms of secondary osteoarthritis.
- Diagnosis of a terminal illness or a health condition that prevents attendance.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual RealityThe 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). | Device | virtual reality |
| Therapeutic exerciseThe 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. | Behavioural | Control |
Primary outcome
Knee osteoarthritis symptoms
Time frame: Baseline and change from baseline at 7th week and at 12th month
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.
Pain Intensity
Time frame: Baseline and change from baseline at 7th week and at 12th month
Visual Analog Scale (VAS) with a score ranging from 0 to 100 millimeters (mm).
Initial positioning
Time frame: Baseline and change from baseline at 7th week and at 12th month
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.
Final positioning
Time frame: Baseline and change from baseline at 7th week and at 12th month
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.
Angular velocity
Time frame: Baseline and change from baseline at 7th week and at 12th month
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).
Acceleration
Time frame: Baseline and change from baseline at 7th week and at 12th month
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).
Movement execution time
Time frame: Baseline and change from baseline at 7th week and at 12th month
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.
Range of joint movement
Time frame: Baseline and change from baseline at 7th week and at 12th month
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.
21 secondary outcomes
Kinesiophobia
Time frame: Baseline
Falls history
Time frame: Baseline and change from baseline at 12th month
General health status
Time frame: Baseline and change from baseline at 7th week and at 12th month
Date of birth
Time frame: Baseline
Gender
Time frame: Baseline
Height
Time frame: Baseline
Weight
Time frame: Baseline
Body mass index (BMI)
Time frame: Baseline
Depressive symptoms
Time frame: Baseline and change from baseline at 7th week and at 12th month
Cognitive capacity
Time frame: Baseline and change from baseline at 7th week and at 12th month
Amount and type of medication consumed
Time frame: Baseline and change from baseline at 7th week and at 12th month
Existence of comorbidity
Time frame: Baseline
Physical performance and fall risk
Time frame: Baseline and change from baseline at 7th week and at 12th month
Lower limb strength and function
Time frame: Baseline and change from baseline at 7th week and at 12th month
Mobility and balance
Time frame: Baseline and change from baseline at 7th week and at 12th month
Muscle Strength
Time frame: Baseline and change from baseline at 7th week and at 12th month
Aerobic capacity
Time frame: Baseline and change from baseline at 7th week and at 12th month
Heart Rate
Time frame: Baseline and change from baseline at 7th week and at 12th month
Blood Pressure
Time frame: Baseline and change from baseline at 7th week and at 12th month
Oxygen Saturation
Time frame: Baseline and change from baseline at 7th week and at 12th month
Cibersickness
Time frame: Baseline and change from baseline at 7th week and at 12th month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2025.
- Background: PubMed 37364059Altenburger P, Ambike SS, Haddad JM. Integrating Motor Variability Evaluation Into Movement System Assessment. Phys Ther. 2023 Oct 3;103(10):pzad075. doi: 10.1093/ptj/pzad075.
- Background: PubMed 34160044Quinn L, Riley N, Tyrell CM, Judd DL, Gill-Body KM, Hedman LD, Packel A, Brown DA, Nabar N, Scheets P. A Framework for Movement Analysis of Tasks: Recommendations From the Academy of Neurologic Physical Therapy's Movement System Task Force. Phys Ther. 2021 Sep 1;101(9):pzab154. doi: 10.1093/ptj/pzab154.
- Background: PubMed 30595096Benham S, Kang M, Grampurohit N. Immersive Virtual Reality for the Management of Pain in Community-Dwelling Older Adults. OTJR (Thorofare N J). 2019 Apr;39(2):90-96. doi: 10.1177/1539449218817291. Epub 2018 Dec 29.
- Background: PubMed 31278997Bannuru RR, Osani MC, Vaysbrot EE, Arden NK, Bennell K, Bierma-Zeinstra SMA, Kraus VB, Lohmander LS, Abbott JH, Bhandari M, Blanco FJ, Espinosa R, Haugen IK, Lin J, Mandl LA, Moilanen E, Nakamura N, Snyder-Mackler L, Trojian T, Underwood M, McAlindon TE. OARSI guidelines for the non-surgical management of knee, hip, and polyarticular osteoarthritis. Osteoarthritis Cartilage. 2019 Nov;27(11):1578-1589. doi: 10.1016/j.joca.2019.06.011. Epub 2019 Jul 3.
- Background: PubMed 17079748Stratford PW, Kennedy DM, Woodhouse LJ. Performance measures provide assessments of pain and function in people with advanced osteoarthritis of the hip or knee. Phys Ther. 2006 Nov;86(11):1489-96. doi: 10.2522/ptj.20060002.
- Derived from this study: PubMed 41120141Tunas-Maceiras I, Pereira J, Pertega Diaz S, Lopez Campos JA, Rodriguez-Romero B. Virtual reality versus conventional exercise for knee osteoarthritis: protocol for a randomised controlled trial on functionality and fall risk. BMJ Open. 2025 Oct 20;15(10):e102776. doi: 10.1136/bmjopen-2025-102776.
- Individual participant dataSharing planned: Yes. The data that support the findings of this study will be openly available in Zenodo.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Beatriz Rodríguez-Romero, PhD study director
Universidade da Coruña
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality and Therapeutic exercise in people with Knee Osteoarthritis and Task Performance and Analysis, run by Universidade da Coruña.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Beatriz Rodríguez-Romero, PhD (00034 981167000 ext. 5841, beatriz.romero@udc.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee osteoarthritis symptoms (time frame: Baseline and change from baseline at 7th week and at 12th month). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06362785, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2025.