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| Name | Class |
|---|---|
| Centre for Information and Communications Technology Research (CITIC) | UNKNOWN |
| Faculty of Physiotherapy | UNKNOWN |
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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.).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Control | Active Comparator | The control group will receive conventional physiotherapy treatment based on therapeutic exercise. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual Reality | Device | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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). | 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. | 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. | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline |
| Falls history |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Beatriz Rodríguez-Romero, PhD | Contact | 00034 981167000 | 5841 | beatriz.romero@udc.es |
| Silvia Rey Abuín | Contact | 00034 981167000 | 1153 | vit@udc.gal |
| Name | Affiliation | Role |
|---|---|---|
| Beatriz Rodríguez-Romero, PhD | Universidade da Coruña | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37364059 | Background | 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. | |
| 34160044 | Background | Quinn 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. |
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The data that support the findings of this study will be openly available in Zenodo.
The supporting information will be available in the official repository of the University of A Coruña for an indefinite period of time.
Upon request of access to the authors of the study.
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
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|
| Therapeutic exercise | Behavioral | 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. |
|
| 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). | 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. | 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. | Baseline and change from baseline at 7th week and at 12th month |
Through an ad hoc question: Have you had any falls in the last year? How many? |
| 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. | 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. | Baseline |
| Gender | Gender will be collected as male or female. | Baseline |
| Height | Height of the individual in meters (m) measured using a stadiometer. | Baseline |
| Weight | Weight of the individual in kilograms (kg) measured using a scale. | Baseline |
| Body mass index (BMI) | Weight and height will be combined to report BMI in kg/m^2. | 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. | 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. | 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? | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Baseline and change from baseline at 7th week and at 12th month |
| 30595096 | Background | Benham 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. |
| 31278997 | Background | Bannuru 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. |
| 17079748 | Background | Stratford 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. |
| 41120141 | Derived | Tunas-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. |
| D012216 |
| Rheumatic Diseases |
| D013812 |
| Therapeutics |
| D026741 | Physical Therapy Modalities |