NCT06639867

Brief Summary

This study is looking at the how the use of non-immersive virtual reality technology can be used to help people that have pain in their knees caused by osteoarthritis. It is a feasibility randomised controlled trial to investigate the feasibility of the use of the intervention by patients in their homes in a larger randomised controlled trial. The intervention is a non-immersive virtual reality system. Through the use of painless sensors, patients are able to control an animated character on a screen through a series of games that replicates real physiotherapy exercises used to treat knee osteoarthritis. This intervention is being compared to a standard care physiotherapy programme. As this is a feasibility study, it has no single primary outcome. Instead, the main outcome measures relate to feasibility of the study. This includes; feasibility of recruitment, completeness of outcome measures, the fidelity of healthcare professionals delivering the intervention, the acceptability of the intervention and trial procedures, adverse events, and adherence of the intervention. Patients are randomised to receive either the intervention or control, and then spend 12-weeks in their assigned treatment. They then receive a 12-week and a 24-week follow up. Patient interviews are offered for those in the intervention arm to collect qualitative data regarding acceptability of the intervention and their participation in the study.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable knee-osteoarthritis

Timeline
2mo left

Started Oct 2024

Typical duration for not_applicable knee-osteoarthritis

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress92%
Oct 2024Jun 2026

Study Start

First participant enrolled

October 4, 2024

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

October 10, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 15, 2024

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 7, 2026

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Expected
Last Updated

January 15, 2026

Status Verified

January 1, 2026

Enrollment Period

1.3 years

First QC Date

October 10, 2024

Last Update Submit

January 13, 2026

Conditions

Knee Osteoarthritis

Keywords

Virtual realityPhysiotherapyHome-based physiotherapy

Outcome Measures

Primary Outcomes (6)

  • Feasibility of recruitment

    Ability to achieve a recruitment and randomisation of 4 patients per month, 50 patients within 13 months (number screened, consented, and randomised will be logged; reasons for non-consent or withdrawal will be recorded).

    13-month recruitment period

  • Completeness of outcome measures

    Number (%) of each questionnaire and mechanistic outcome completed at 12-weeks and 24-weeks post randomisation.

    24-week follow up

  • Fidelity of healthcare professionals delivering intervention

    Treatment logs for face-to-face contact, observation of two assessments and training sessions for setting up patients with knee osteoarthritis with the intervention.

    12-week intervention period

  • Acceptability of intervention and trial procedures

    Interviews with patients and staff about expectations and experience of the intervention, and barriers and facilitators to trial participation.

    12-week intervention period

  • Adverse events

    Treatment logs and patient interviews will be used to find issues related to knee symptoms or muscle soreness and falls, and motion sickness, plus any unexpected adverse events.

    24-week follow up

  • Adherence to the intervention

    Number of times and date/time of when patients logged in to the VR games and number of physiotherapy follow-up consultations.

    12-week intervention period

Secondary Outcomes (2)

  • Evaluate the processes for exercise mechanism of action at improving pain outcomes

    24-week follow up

  • Assess intervention to treat knee osteoarthritis

    24-week follow up

Study Arms (2)

VR-based home physiotherapy

EXPERIMENTAL

Home-based non-immersive virtual reality using sensors strapped to the users limbs and body. They take part in a variety of games associated with movements of physiotherapy exercises.

Device: VR-based home physiotherapy

Standard physiotherapy care

ACTIVE COMPARATOR

Standard care as prescribed by the treating physiotherapist.

Other: Standard physiotherapy care

Interventions

VR-based home physiotherapyDEVICE

VR-based home physiotherapy

VR-based home physiotherapy
Standard physiotherapy careOTHER

Standard physiotherapy care as prescribed by the treating physiotherapist

Standard physiotherapy care

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults aged 45 or older years
  • Clinical diagnosis of knee osteoarthritis
  • Referred for physiotherapy for clinically diagnosed knee osteoarthritis pain
  • Activity related joint pain
  • Self-reported knee pain on most days for the past 3 months
  • Average pain severity in the past week of 4 or greater on a 10-point numeric rating scale
  • Able to understand written and spoken English
  • Able to provide written informed consent

You may not qualify if:

  • Where knee is not identified by the participant as the main source of pain (e.g. comorbid painful conditions, widespread pain).
  • Contraindication to exercise
  • Pain caused by malignancy, fractures, or inflammatory arthritis
  • Has received surgery for their knee pain in the last 12 months
  • Has commenced another new treatment for knee pain, including intra-articular injection, during the preceding 12 weeks
  • Concurrent ongoing treatment by physiotherapy other than the trial interventions
  • Previous knee arthroplasty in either knee
  • Unable to walk without a walking aid
  • Unable or unwilling to engage in either active or control intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Cardiff University School of Healthcare Sciences

Cardiff, United Kingdom

Location

University Hospital of Wales

Cardiff, United Kingdom

Location

Related Publications (1)

  • Al-Amri M, Bird S, Nistor DT, White J, Button K, Warner M, Walsh D, Shorten D, Evans R. Evaluating home-based personalised virtual reality physiotherapy rehabilitation compared with usual care in the treatment of pain for people with knee osteoarthritis: protocol for a randomised feasibility study. BMJ Open. 2025 Oct 21;15(10):e102994. doi: 10.1136/bmjopen-2025-102994.

    PMID: 41125281DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 10, 2024

First Posted

October 15, 2024

Study Start

October 4, 2024

Primary Completion

January 7, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

January 15, 2026

Record last verified: 2026-01

Locations

GB(2)