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| Name | Class |
|---|---|
| Hospital Vall d'Hebron | OTHER |
| Villa Beretta Rehabilitation Center | OTHER |
| German Research Center for Artificial Intelligence (DFKI) | UNKNOWN |
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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:
Methodology
The project will conduct a two-site RCT with CLBP patients. Participants will be randomly allocated to:
XR rehabilitation:
Usual care: standard group rehabilitation sessions for 8 weeks.
Primary outcomes:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mixed realities rehabilitation program | Experimental |
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| Usual Care | Active Comparator | Group rehabilitation sessions: 8 weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mixed realities rehabilitation program | Other |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37217536 | Result | 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. |
| Label | URL |
|---|---|
| Related Info | View source |
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Two-site randomized controlled trial.
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| Usual Care | Other | Group rehabilitation sessions: 8 weeks |
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