Knee OsteoarthritisSPIN-VRNCT06639867
Sensor-based Physiotherapy Intervention With Virtual Reality
A study testing VR-based home physiotherapy and Standard physiotherapy care in people with Knee Osteoarthritis, run by Cardiff University at 2 sites in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- VR-based home physiotherapy and Standard physiotherapy care
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 4 Oct 2024to 2 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- Previous knee arthroplasty in either knee
- Unable to walk without a walking aid
- Unable or unwilling to engage in either active or control intervention
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Cardiff University School of Healthcare Sciences
Cardiff
University Hospital of Wales
Cardiff
About this study
Official title: A Randomised Feasibility Study to Evaluate Home-based Personalised Virtual Reality Physiotherapy Rehabilitation Compared to Usual Care in the Treatment of Pain for People With Knee Osteoarthritis
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.
Read more
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.
Read the detailed description
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. This involves sensors that are strapped to the user's arms, legs, head, or chest (depending on the specific exercise). Their movement then controls a character on the screen of either a laptop or a TV. Patients then work through a series of games that replicate physiotherapist exercises. Their performance in the games determines the difficulty of the games, and as patients improve, the exercises get harder. Patients are required to perform these exercises 3 times a week over 12 weeks. During this time, patients have the opportunity to attend clinics with a physiotherapist to review their progress. This intervention is being compared to standard care physiotherapy exercises that patients perform at home in their own time. This programme is prescribed to them by a physiotherapist, and they are followed up regularly over 12 weeks as they perform the programme at home.
This is a feasibility study, and has no single primary outcome or objective. Instead, there are several main outcomes and objectives related to the feasibility of the study and the intervention. The feasibility of recruitment to the study will be measured by the ability to achieve a recruitment of 4 patients per month, over 13 months. The recruitment target is 50. Patient willingness to be randomised will be measured by the reasons for non-consent and withdrawal given by patients. The completeness of outcome measures is measured by the of questionnaires and outcomes completed at 12- and 24-weeks post randomisation. The fidelity of healthcare professionals delivering the intervention will be measured by treatment logs for face-to-face contact, and the observation of two assessments for setting up knee osteoarthritis patients with the intervention. The acceptability of intervention and trial procedures to participants will be measured by interviews with patients and staff about expectations and experience of the intervention, and barriers and facilitators to trial participation. Adverse events experienced by participants from the intervention and trial procedures will also be measure by treatment logs. Adherence to the physiotherapy programme will be measured by the number of times and when patients logged in to the VR games and if follow up consultations were used. There are a variety of secondary objectives and outcome measures. A variety of measurements relating to muscle strength and endurance, aerobic capacity, exercise technique, central pain processing, and self-reported pain mechanisms and moderators will be used to understand how the exercises work to improve pain outcomes. The ability of the intervention to treat knee osteoarthritis will be measured by the OMERACT-OARSI core domain set, a variety of patient-reported outcome measures, pain sensitisation by algometer, and a dynamic balance using a step test.
The target population is adults with knee osteoarthritis who fulfil the NICE and ACR criteria for knee osteoarthritis diagnosis and who have been referred to a physiotherapy clinic.
- Conditions
- Knee Osteoarthritis
- Being tested
- VR-based home physiotherapy, Standard physiotherapy care
- Keywords
- Virtual reality, Physiotherapy, Home-based physiotherapy
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR-based home physiotherapyDevice
VR-based home physiotherapy
Standard physiotherapy careOther
Standard physiotherapy care as prescribed by the treating physiotherapist
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: VR-based home physiotherapy |
| Standard physiotherapy care | Active comparator | Standard care as prescribed by the treating physiotherapist. Receives: Other: Standard physiotherapy care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 13-month recruitment period
Completeness of outcome measures
Number (%) of each questionnaire and mechanistic outcome completed at 12-weeks and 24-weeks post randomisation.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12-week intervention period
Secondary outcomes (2)
Evaluate the processes for exercise mechanism of action at improving pain outcomes
A variety of measurements relating to muscle strength and endurance, aerobic capacity, exercise technique, central pain processing, and self-reported pain outcomes and moderators.
Measured: 24-week follow up
Assess intervention to treat knee osteoarthritis
The OMERACT-OARSI core domain set. A variety of patient-reported outcome measures. Pain sensitisation by algometer. Dynamic balance using a step test.
Measured: 24-week follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start4 Oct 2024
- Primary completion7 Jan 2026
- Study completion2 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardiff University
- Sponsor type
- University, hospital or other
- Collaborators
- Centre for Healthcare Evaluation, Device Assessment, and Research (CEDAR)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06639867
- Sponsor's protocol ID
- SPON1947-23
- Acronym
- SPIN-VR
- Status last verified
- Oct 2026
- First submitted
- 10 Oct 2024
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 41125281
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Feasibility Study to Evaluate Home-based Personalised Virtual Reality Physiotherapy Rehabilitation Compared to Usual Care in the Treatment of Pain for People With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT06639867
- Acronym / sponsor ID
- SPIN-VR / SPON1947-23
- Conditions
- Knee Osteoarthritis
- Keywords
- Virtual reality, Physiotherapy, Home-based physiotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Cardiff UniversityUniversity, hospital or other
- Collaborators
- Centre for Healthcare Evaluation, Device Assessment, and Research (CEDAR)
- Study start
- 4 Oct 2024 (actual)
- Primary completion
- 7 Jan 2026 (actual)
- Study completion
- 2 Apr 2026 (actual)
- First posted
- 15 Oct 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.
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.
Detailed description
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. This involves sensors that are strapped to the user's arms, legs, head, or chest (depending on the specific exercise). Their movement then controls a character on the screen of either a laptop or a TV. Patients then work through a series of games that replicate physiotherapist exercises. Their performance in the games determines the difficulty of the games, and as patients improve, the exercises get harder. Patients are required to perform these exercises 3 times a week over 12 weeks. During this time, patients have the opportunity to attend clinics with a physiotherapist to review their progress. This intervention is being compared to standard care physiotherapy exercises that patients perform at home in their own time. This programme is prescribed to them by a physiotherapist, and they are followed up regularly over 12 weeks as they perform the programme at home.
This is a feasibility study, and has no single primary outcome or objective. Instead, there are several main outcomes and objectives related to the feasibility of the study and the intervention. The feasibility of recruitment to the study will be measured by the ability to achieve a recruitment of 4 patients per month, over 13 months. The recruitment target is 50. Patient willingness to be randomised will be measured by the reasons for non-consent and withdrawal given by patients. The completeness of outcome measures is measured by the of questionnaires and outcomes completed at 12- and 24-weeks post randomisation. The fidelity of healthcare professionals delivering the intervention will be measured by treatment logs for face-to-face contact, and the observation of two assessments for setting up knee osteoarthritis patients with the intervention. The acceptability of intervention and trial procedures to participants will be measured by interviews with patients and staff about expectations and experience of the intervention, and barriers and facilitators to trial participation. Adverse events experienced by participants from the intervention and trial procedures will also be measure by treatment logs. Adherence to the physiotherapy programme will be measured by the number of times and when patients logged in to the VR games and if follow up consultations were used. There are a variety of secondary objectives and outcome measures. A variety of measurements relating to muscle strength and endurance, aerobic capacity, exercise technique, central pain processing, and self-reported pain mechanisms and moderators will be used to understand how the exercises work to improve pain outcomes. The ability of the intervention to treat knee osteoarthritis will be measured by the OMERACT-OARSI core domain set, a variety of patient-reported outcome measures, pain sensitisation by algometer, and a dynamic balance using a step test.
The target population is adults with knee osteoarthritis who fulfil the NICE and ACR criteria for knee osteoarthritis diagnosis and who have been referred to a physiotherapy clinic.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VR-based home physiotherapy | Experimental | Device: VR-based home physiotherapyHome-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. |
| Standard physiotherapy care | Active comparator | Other: Standard physiotherapy careStandard care as prescribed by the treating physiotherapist. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (9 listed)
- 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
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 |
|---|---|---|
| VR-based home physiotherapyVR-based home physiotherapy | Device | VR-based home physiotherapy |
| Standard physiotherapy careStandard physiotherapy care as prescribed by the treating physiotherapist | Other | Standard physiotherapy care |
Primary outcome
Feasibility of recruitment
Time frame: 13-month recruitment period
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).
Completeness of outcome measures
Time frame: 24-week follow up
Number (%) of each questionnaire and mechanistic outcome completed at 12-weeks and 24-weeks post randomisation.
Fidelity of healthcare professionals delivering intervention
Time frame: 12-week intervention period
Treatment logs for face-to-face contact, observation of two assessments and training sessions for setting up patients with knee osteoarthritis with the intervention.
Acceptability of intervention and trial procedures
Time frame: 12-week intervention period
Interviews with patients and staff about expectations and experience of the intervention, and barriers and facilitators to trial participation.
Adverse events
Time frame: 24-week follow up
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.
Adherence to the intervention
Time frame: 12-week intervention period
Number of times and date/time of when patients logged in to the VR games and number of physiotherapy follow-up consultations.
2 secondary outcomes
Evaluate the processes for exercise mechanism of action at improving pain outcomes
Time frame: 24-week follow up
Assess intervention to treat knee osteoarthritis
Time frame: 24-week follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- Derived from this study: PubMed 41125281Al-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.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VR-based home physiotherapy and Standard physiotherapy care in people with Knee Osteoarthritis, run by Cardiff University at 2 sites in United Kingdom.
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 8 inclusion and 9 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: finished, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of recruitment (time frame: 13-month recruitment period). The study lists 6 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 NCT06639867, which also lists 1 linked publication.
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 23 Oct 2026.