Health TrialsbyHealthPanel

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

ConditionsKnee OsteoarthritisTask Performance and AnalysisAccidental FallsVirtual Reality
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorUniversidade da Coruña

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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).

  • 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.

Treatment groups

110 Participants
are divided into 2 treatment groups
Group A: virtual realityExperimental treatment 1 intervention
Group B: ControlActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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
3

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
4

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

Secondary outcomes

1

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
2

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
3

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
4

Date of birth

Date of birth will be collected as day/month/year.

Time frame
Baseline

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Universidade da Coruña

Lead sponsor

Centre for Information and Communications Technology Research (CITIC)

Collaborator

Faculty of Physiotherapy

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: