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

Обзор

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.

Вмешательства

• Другое Mixed realities rehabilitation program
  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
• Другое Usual Care
  Group rehabilitation sessions: 8 weeks

Первичные конечные точки

• Pain intensity by VAS (0-100mm) [Срок оценки: Baseline, through study completion, an average of 8 week and follow-up at 6, 12 and 18]
• Pain intensity by Brief Pain Inventory [Срок оценки: Baseline, through study completion, an average of 8 week and follow-up at 6, 12 and 18]
• Pain disability by Oswestry Disability Index (ODI) [Срок оценки: 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) [Срок оценки: Baseline, through study completion, an average of 8 week and follow-up at 6, 12 and 18]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• 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

Идентификаторы

NCT: NCT07202975 · RE-SCALE

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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