Knee Osteoarthritis, Motor Control, Risk of Falls and Virtual Reality

NCT06362785 | Not Yet Recruiting

• 1 other identifier: Virtual Reality-Seniors
• Study Type: interventional
• Target: 110
• Locations: 0 countries
• Sites: N/A

Brief 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 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.

Conditions

Knee Osteoarthritis; Task Performance and Analysis; Accidental Falls; Virtual Reality

Keywords

Knee osteoarthritis; Task Performance and Analysis; Accidental Falls; Aged; Virtual Reality

Outcome Measures

Primary Outcomes (8)

• 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).

  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

Secondary Outcomes (21)

• Kinesiophobia

  Baseline

• Falls history

  Baseline and change from baseline at 12th month

• General health status

  Baseline and change from baseline at 7th week and at 12th month

• Date of birth

  Baseline

• Gender

  Baseline

Study Arms (2)

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.

Device: Virtual Reality

Control

ACTIVE COMPARATOR

The control group will receive conventional physiotherapy treatment based on therapeutic exercise.

Behavioral: Therapeutic exercise

Interventions

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).

virtual reality

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.

Control

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidade da Coruña: lead
• Centre for Information and Communications Technology Research (CITIC): collaborator
• Faculty of Physiotherapy: collaborator

Related Publications (6)

• 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.

  PMID: 37364059 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.

  PMID: 34160044 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.

  PMID: 30595096 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.

  PMID: 31278997 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.

  PMID: 17079748 BACKGROUND

• 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.

  PMID: 41120141 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Officials

• Beatriz Rodríguez-Romero, PhD

  Universidade da Coruña

  STUDY DIRECTOR

Central Study Contacts

Beatriz Rodríguez-Romero, PhD

CONTACT

00034 981167000; beatriz.romero@udc.es

Silvia Rey Abuín

CONTACT

00034 981167000; vit@udc.gal

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2024
• First Posted: April 12, 2024
• Study Start: May 1, 2025
• Primary Completion: December 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: March 17, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• 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.