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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other, Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 45
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
United Kingdom
Cardiff University School of Healthcare Sciences
RECRUITING
Cardiff
University Hospital of Wales
RECRUITING
Cardiff
Contact Information
Primary
Mohammad Al-Amri
Al-AmriM@cardiff.ac.uk
02920 687 115
Backup
Samuel Bird
Samuel.Bird2@wales.nhs.uk
029 21 848 692
Time Frame
Start Date: 2024-06-04
Estimated Completion Date: 2026-04-02
Participants
Target number of participants: 50
Treatments
Experimental: VR-based home physiotherapy
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.
Active_comparator: Standard physiotherapy care
Standard care as prescribed by the treating physiotherapist.
Related Therapeutic Areas
Sponsors
Leads: Cardiff University
Collaborators: Centre for Healthcare Evaluation, Device Assessment, and Research (CEDAR)

This content was sourced from clinicaltrials.gov