RE-SCALE: Rehabilitation Engagement and Scaled Access With eXtended Reality and Artificial Intelligence
Not yet recruitingNot applicableNCT07202975
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
Background Chronic musculoskeletal pain, especially chronic low back pain (CLBP), is the leading cause of disability worldwide, with a burden expected to rise due to aging and increased longevity. Despite strong evidence supporting multimodal and non-pharmacological management-particularly active physical therapy and self-management-clinical practice still shows low adherence to guidelines, with excessive reliance on imaging, rest, injections, and surgery. Adherence to physical therapy remains one of the most significant barriers: only 40-50% of patients follow prescribed exercise programs. Factors include kinesiophobia, low motivation, and logistical obstacles. Mixed realities (XR: VR, AR, MR) offer solutions by enhancing motivation, reducing barriers, and personalizing rehabilitation. Evidence from systematic reviews shows VR-based rehabilitation can reduce pain, disability, and kinesiophobia, with immersive VR offering additional benefits like presence and habit-building. The SHARESPACE project developed and tested a novel XR rehabilitation environment for CLBP that integrates immersive VR/AR, tele-rehabilitation, real-time motor tracking, avatars for social support, and cognitive architectures for synchronization. Usability studies with patients, clinicians, and the general population confirm its feasibility and acceptance. SHARESPACE has completed phases 1 and 2 of XR intervention development (design and feasibility), now aiming to move to phase 3: large-scale clinical validation. Objectives The main goal is to evaluate not only short-term efficacy but long-term, as well as including more accurate and objective measures. A second objective is the commercial exploitation WE will valuate the efficacy, adherence, and cost-effectiveness of the SHARESPACE XR rehabilitation system compared to usual care in patients with CLBP. Specific objectives include: 1. To conduct a two-site randomized controlled trial (RCT) comparing XR rehabilitation with conventional group reh…
Study details
- Official title
- RE-SCALE: Rehabilitation Engagement and Scaled Access With eXtended Reality and Artificial Intelligence
- Conditions
- Interventions
- Other: Mixed realities rehabilitation program
- Other: Usual Care
- Sponsor
- Universitat Jaume I
- Collaborators
- Hospital Vall d'Hebron; Villa Beretta Rehabilitation Center; German Research Center for Artificial Intelligence (DFKI)
- Start date
- 2027-01-01
- Primary completion
- 2027-07-01
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Total sites listed
- 0
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Age range: Adults over 18 and under 70 * Diagnosis of chronic low back pain with or without radiculopathy * Minimum of moderate disability (21% ODI score) * Acceptance of participation and signed consent form * Internet access at home Exclusion Criteria: * History of spinal surgery or fracture * Signs of upper motor neuron injury: bilateral paresthesia, hyperreflexia, or spasticity, or other negative signs such as fractures * Other severe medical or psychological conditions that prevent participation in the trial.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT07202975