NCT07202975

RE-SCALE: Rehabilitation Engagement and Scaled Access With eXtended Reality and Artificial Intelligence

Not yet recruiting NA Last updated 2 October 2025

What this trial tests

NA trial testing Mixed realities rehabilitation program in Chronic Low Back Pain (CLBP) in 314 participants. Not yet recruiting.

Timeline

1 January 2027

Primary endpoint
1 July 2027

31 December 2027

Quick facts

Lead sponsor	Universitat Jaume I
Phase	NA
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	314
Start date	1 January 2027
Primary completion	1 July 2027
Estimated completion	31 December 2027

Drugs / interventions tested

• Mixed realities rehabilitation program
• Usual Care

Conditions studied

• Chronic Low Back Pain (CLBP) — all drugs for Chronic Low Back Pain (CLBP) →

Sponsor

Universitat Jaume I — full company profile →

Who can join

18 and older, any sex, with Chronic Low Back Pain (CLBP). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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 rehabilitation.
2. To assess both short-term and long-term outcomes (pain intensity, disability, kinesiophobia).
3. To monitor and improve adherence through ecological momentary assessment and intervention (EMA/EMI) using an app and activity trackers.
4. To enhance motivation and engagement with gamification, social connectedness, and avatar-based interaction.
5. To generate evidence for commercial exploitation and integration into health systems.

Methodology

The project will conduct a two-site RCT with CLBP patients. Participants will be randomly allocated to:

* XR rehabilitation:

* Two hospital sessions (traditional + XR-assisted training).
* Four remote XR sessions with therapist and patients (L1 avatars).
* Continued home-based XR with automated therapist avatars (L3) for up to 120 days.
* Integration of EMA/EMI via an app and wearable devices to monitor daily activity, sleep, and adherence, with automated prompts to encourage compliance.
* Usual care: standard group rehabilitation sessions for 8 weeks.

Primary outcomes:

* Pain intensity (VAS, BPI).
* Disability (Oswestry Disability Index).
* Kinesiophobia (Tampa Scale of Kinesiophobia). Secondary outcomes: adherence rates, motivation, patient satisfaction, feasibility, and cost-effectiveness. Motor performance data will be captured in real time via XR tracking and transmitted to therapists for feedback.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.