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| Name | Class |
|---|---|
| Universidad San Sebastián | OTHER |
| University of Alcala | OTHER |
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Fibromyalgia (FM) is a primary chronic pain condition with an estimated prevalence of 3.3% in Chile. It is characterized by widespread musculoskeletal pain, fatigue, and impaired physical function. Although exercise therapy is considered the first-line intervention, barriers to access and poor adherence limit its effectiveness within the public healthcare system. This study evaluates the effectiveness of an Artificial Intelligence (AI)- and Computer Vision (CV)-assisted telerehabilitation platform called Rehbody. The aim is to determine whether real-time technology-driven feedback can overcome the limitations of traditional face-to-face rehabilitation models by improving disease impact and functional capacity in Chilean patients with fibromyalgia.
This superiority randomized controlled trial compares two digital telerehabilitation modalities with usual care. The intervention is delivered through the Rehbody platform, which uses computer vision algorithms to capture movement patterns through the camera of mobile devices, enabling the detection of joint angles and postural errors. The system provides immediate audiovisual feedback, ensuring safe and accurate exercise performance comparable to in-person supervision.
The primary statistical analysis will follow the Intention-to-Treat (ITT) principle using an Analysis of Covariance (ANCOVA) model, with baseline measurements included as covariates to reduce error variance. To assess the integrity of assessor blinding, the Bang Blinding Index will be administered at the end of Week 13. The study adheres to the SPIRIT 2013 and CONSORT 2010 reporting standards.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: AI Mobility | Experimental | Mobility and stretching exercise program delivered through the Rehbody platform (AI/CV-assisted) in addition to usual care. The program includes seven specific exercises. |
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| Arm 2: AI Combined (mobility and resistance training) | Experimental | Cumulative intervention consisting of the mobility and stretching program described in Arm 1 plus AI/CV-assisted resistance training delivered through Rehbody, in addition to usual care. Total: 11 exercises. |
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| Usual Care | No Intervention | Continuation of usual care, including medical management, pharmacological treatment, and conventional physiotherapy when applicable. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AI Combined (mobility and resistance training) | Other | Frequency: Twice weekly. Intensity: Borg Rating of Perceived Exertion (RPE) scale 4-6/10. Number of exercises: 11. Sets and repetitions: 2 sets of 10-15 repetitions for mobility exercises. 10-12 repetitions for resistance training exercises. 4 repetitions for stretching exercises. Rest interval: 20-60 seconds between sets. Total intervention duration: 12 weeks. Mobility exercises (10-15 minutes): Overhead Shoulder Raise (Bodyweight) Right Knee Raise with Arm Movement (Standing) Left Knee Raise with Arm Movement (Standing) Full Left Ankle Dorsiflexion-Plantarflexion (Standing) Full Right Ankle Dorsiflexion-Plantarflexion (Standing) Resistance training exercises (15-20 minutes): 6. Weighted Deadlift 7. Chair Squat 8. Weighted Lateral Shoulder Raise 9. Bilateral Dumbbell Bent-Over Row Stretching exercises (5 minutes): 10. Seated Cervical Flexion Stretch 11. Kneeling Prayer Stretch |
| Measure | Description | Time Frame |
|---|---|---|
| Fibromyalgia Impact Questionnaire-Revised (FIQ-R) | The Fibromyalgia Impact Questionnaire-Revised (FIQ-R) is a 21-item self-reported instrument that assesses physical function, overall impact, and symptom severity in individuals with fibromyalgia. The Chilean validated version demonstrates excellent internal consistency (Cronbach's α = 0.91), good test-retest reliability (ICC = 0.90), and adequate convergent validity through significant correlations with pain intensity, pain interference, symptom severity, and health-related quality of life (Escobar, 2018). Total scores range from 0 to 100, with higher scores indicating greater disease impact. The questionnaire requires approximately 1.3 minutes to complete (Carrasco-Vega et al., 2023). A 14% change in the total FIQ-R score was considered the Minimal Detectable Change (MDC) (Bennett, Friend, et al., 2009). Assessments will be conducted at baseline (Week 0), post-intervention (Week 13), and follow-up (Week 25). | 6 months |
| 30-Second Sit-to-Stand Test (30s-STS) Performance | The 30-Second Sit-to-Stand Test (30s-STS) assesses lower-limb strength through a physical performance measure. It has demonstrated good to excellent test-retest reliability (ICC: 0.85-0.91), adequate known-groups validity for distinguishing individuals with and without fibromyalgia, and a minimal detectable change of ≥3 repetitions (Socorro-Cumplido et al., 2024). The test is associated with handgrip strength, muscle mass, balance, functional capacity, overall physical performance, and mobility- and quality of life-related outcomes (Kakavas et al., 2020; Khuna et al., 2024). Participants are instructed to perform as many sit-to-stand repetitions as possible within 30 seconds without using their arms, while the assessor records the total number of repetitions. The 30s-STS has been validated for remote administration in telehealth settings and for use in the Chilean population. Assessments will be conducted at baseline (Week 0), post-intervention (Week 13), and follow-up (Week 25). | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Catastrophizing | It will be assessed using The 4-item Pain Catastrophizing Scale (PCS-4) is a shortened version of the original 13-item Pain Catastrophizing Scale designed to assess catastrophic thinking related to pain in individuals with musculoskeletal conditions. The Spanish version has been validated in the Chilean population and demonstrates a unidimensional structure, high internal consistency (Cronbach's α = 0.84; McDonald's ω = 0.84), and evidence of validity through associations with pain intensity, pain interference, and kinesiophobia (Bascour-Sandoval et al., 2022). The questionnaire is self-administered and consists of four items rated on a 5-point Likert scale from 0 ("not at all") to 4 ("all the time"). Total scores range from 0 to 16, with higher scores indicating greater levels of pain catastrophizing. Assessments will be conducted at baseline (Week 0), post-intervention (Week 13), and follow-up (Week 25). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Romualdo Luciano Ordóñez Vega, Master, and PhD student | Contact | +56982256426 | kine.ordonez@gmail.com | |
| Marco Antonio Morales Osorio, PhD | Contact | +56 9 3236 7359 | marco.morales.osorio@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Daniel Pecos Martín, PhD | University of Alcala | Study Director |
| José Manuel Gómez Pulido, PhD | University of Alcala | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40090120 | Background | Perez-Huerta BD, Diaz-Pulido B, Godinez-Jaimes F, Gomez-Rodriguez R, Godfrey EL, Sanchez-Sanchez B. Cultural adaptation and psychometric validation of the exercise adherence Rating scale Mexican Spanish version (EARS-Mx). Musculoskelet Sci Pract. 2025 Jun;77:103308. doi: 10.1016/j.msksp.2025.103308. Epub 2025 Mar 7. | |
| 35485547 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | May 20, 2026 | Jun 27, 2026 | Prot_SAP_ICF_001.pdf |
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| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
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| ID | Term |
|---|---|
| D016059 | Range of Motion, Articular |
| D055070 | Resistance Training |
| D000088543 | Aquatic Therapy |
| D001185 | Artificial Intelligence |
| ID | Term |
|---|---|
| D010808 | Physical Examination |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D009142 | Musculoskeletal Physiological Phenomena |
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A three-arm parallel-group randomized controlled trial with a 1:1:1 allocation ratio, superiority design, 3-month follow-up, and intention-to-treat analysis will be conducted. Participants will be randomly assigned to one of the three study groups.
The study protocol has been developed in accordance with the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 2013 guidelines, ensuring that all critical aspects of the design, conduct, and reporting of the clinical trial are adequately addressed (Chan et al., 2013).
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Single (Outcomes Assessor and Statistical Analyst). Participants and physiotherapists cannot be blinded due to the active nature of the exercise intervention. The success of blinding will be quantified using the Bang Blinding Index.
|
|
| AI mobility | Other | Frequency: Twice weekly. Intensity: Borg Rating of Perceived Exertion (RPE) scale 4-6/10. Number of exercises: 7. Sets and repetitions: 2 sets of 10-15 repetitions for mobility exercises. 4 repetitions for stretching exercises. Rest interval: 20-60 seconds between sets. Total intervention duration: 12 weeks. Mobility exercises (10-15 minutes): Overhead Shoulder Raise (Bodyweight) Right Knee Raise with Arm Movement (Standing) Left Knee Raise with Arm Movement (Standing) Full Left Ankle Dorsiflexion-Plantarflexion (Standing) Full Right Ankle Dorsiflexion-Plantarflexion (Standing) Stretching exercises (5 minutes): Seated Cervical Flexion Stretch Kneeling Prayer Stretch |
|
|
| 6 months |
| Exercise adherence | Exercise adherence refers to the extent to which participants comply with prescribed therapeutic exercise recommendations and sessions. It will be assessed using Section B of the Exercise Adherence Rating Scale (EARS), a six-item self-report instrument that evaluates adherence behaviors related to home-based exercise programs. Total scores range from 0 to 24, with higher scores indicating greater adherence to the prescribed exercise program. The Spanish version has demonstrated excellent psychometric properties, including high internal consistency (Cronbach's α = 0.93) and excellent test-retest reliability (ICC = 0.95) (Pérez-Huerta et al., 2025). Although the instrument has not been specifically validated in the Chilean population, it will be used as a complementary measure to support the interpretation of clinical outcomes. Assessments will be conducted at baseline (Week 0), post-intervention (Week 13), and follow-up (Week 25). | 6 months |
| Sociodemographic and Baseline Clinical Characteristics | Sociodemographic and clinical characteristics will be collected to describe the study population and assess baseline comparability across trial arms. Sociodemographic variables will include age, gender, marital status, educational level, employment status, Previous exercise experience and access to technology. Clinical variables will include time since fibromyalgia diagnosis, pharmacological treatment, and comorbidities. These variables will be analyzed descriptively. Continuous variables will be summarized using measures of central tendency and dispersion, whereas categorical variables will be reported as frequencies and proportions. | Week 0 |
| Bascour-Sandoval C, Albayay J, Martinez-Molina A, Opazo-Sepulveda A, Lacoste-Abarzua C, Bielefeldt-Astudillo D, Gajardo-Burgos R, Galvez-Garcia G. Psychometric Properties of the PCS and the PCS-4 in Individuals With Musculoskeletal Pain. Psicothema. 2022 May;34(2):323-331. doi: 10.7334/psicothema2021.21. |
| 37184415 | Background | Carrasco-Vega E, Martinez-Moya M, Barni L, Guiducci S, Nacci F, Gonzalez-Sanchez M. Questionnaires for the subjective evaluation of patients with fibromyalgia: a systematic review. Eur J Phys Rehabil Med. 2023 Jun;59(3):353-363. doi: 10.23736/S1973-9087.23.07762-6. Epub 2023 May 15. |
| 39615810 | Background | Socorro-Cumplido JL, Chaler J, Almirall M, Sanchez-Raya J, Cano M, Roman-Vinas B. Psychometric properties of performance based tests in patients with Fibromyalgia: A systematic review. J Pain. 2025 Apr;29:104749. doi: 10.1016/j.jpain.2024.104749. Epub 2024 Nov 28. |
| 36893316 | Background | Duran J, Tejos-Bravo M, Cid V, Ferreccio C, Calvo M. Chronic pain in Chile: first prevalence report of noncancer chronic pain, fibromyalgia, and neuropathic pain and its associated factors. Pain. 2023 Aug 1;164(8):1852-1859. doi: 10.1097/j.pain.0000000000002886. Epub 2023 Mar 9. |
| 27916278 | Background | Wolfe F, Clauw DJ, Fitzcharles MA, Goldenberg DL, Hauser W, Katz RL, Mease PJ, Russell AS, Russell IJ, Walitt B. 2016 Revisions to the 2010/2011 fibromyalgia diagnostic criteria. Semin Arthritis Rheum. 2016 Dec;46(3):319-329. doi: 10.1016/j.semarthrit.2016.08.012. Epub 2016 Aug 30. |
| 30586075 | Background | Smith BH, Fors EA, Korwisi B, Barke A, Cameron P, Colvin L, Richardson C, Rief W, Treede RD; IASP Taskforce for the Classification of Chronic Pain. The IASP classification of chronic pain for ICD-11: applicability in primary care. Pain. 2019 Jan;160(1):83-87. doi: 10.1097/j.pain.0000000000001360. |
| D009422 |
| Nervous System Diseases |
| D001519 | Behavior |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D064797 | Physical Conditioning, Human |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D006875 | Hydrotherapy |
| D000465 | Algorithms |
| D055641 | Mathematical Concepts |