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

NCT07202975 | Not Yet Recruiting

• 1 other identifier: RE-SCALE
• Study Type: interventional
• Target: 314
• Locations: 0 countries
• Sites: N/A

Brief Summary

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:

• 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.

Conditions

Chronic Low Back Pain (CLBP)

Outcome Measures

Primary Outcomes (4)

• Pain intensity by VAS (0-100mm)

  Significant change at 25 mm

  Baseline, through study completion, an average of 8 week and follow-up at 6, 12 and 18

• Pain intensity by Brief Pain Inventory

  Baseline, through study completion, an average of 8 week and follow-up at 6, 12 and 18

• Pain disability by Oswestry Disability Index (ODI)

  Baseline, through study completion, an average of 8 week and follow-up at 6, 12 and 18

• Pain Kinesiophobia by Tampa Scale of Kinesiophobia (TSK)

  Baseline, through study completion, an average of 8 week and follow-up at 6, 12 and 18

Study Arms (2)

Mixed realities rehabilitation program

EXPERIMENTAL

1. Two sessions at the hospital: one session with traditional exercise + one session with traditional exercise and training with XR system ( 2 weeks) 2. Four more sessions at home with therapist (L1 therapist and L1 patients) (4 weeks) 3. Former sessions (until 120 days) with L3 therapist and L1 and L3 patients.

Other: Mixed realities rehabilitation program

Usual Care

ACTIVE COMPARATOR

Group rehabilitation sessions: 8 weeks

Other: Usual Care

Interventions

Mixed realities rehabilitation program OTHER

1. Two sessions at the hospital: one session with traditional exercise + one session with traditional exercise and training with XR system ( 2 weeks) 2. Four more sessions at home with therapist (L1 therapist and L1 patients) (4 weeks) 3. Former sessions (until 120 days) with L3 therapist and L1 and L3 patients. Usual care: Group rehabilitation sessions: 8 weeks

Mixed realities rehabilitation program

Usual Care OTHER

Group rehabilitation sessions: 8 weeks

Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitat Jaume I: lead
• Hospital Vall d'Hebron: collaborator
• Villa Beretta Rehabilitation Research innovation Institute: collaborator
• German Research Center for Artificial Intelligence (DFKI): collaborator

Related Publications (1)

• Hoffman HG, Fontenot MR, Garcia-Palacios A, Greenleaf WJ, Alhalabi W, Curatolo M, Flor H. Adding tactile feedback increases avatar ownership and makes virtual reality more effective at reducing pain in a randomized crossover study. Sci Rep. 2023 May 22;13(1):7915. doi: 10.1038/s41598-023-31038-4.

  PMID: 37217536 BACKGROUND

Related Links

• Related Info

Study Design

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

Model Details: Two-site randomized controlled trial.

Study Record Dates

• First Submitted: September 15, 2025
• First Posted: October 2, 2025
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: October 2, 2025

Record last verified: 2025-09