AI and Computer Vision-Assisted Telerehabilitation in Fibromyalgia: The FibroIA 2.0 Trial

NCT07674485 | Not Yet Recruiting DMC

• 1 other identifier: FibroIA 2
• Study Type: interventional
• Target: 66
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Fibromyalgia; Fibromyalgia (FM); Fibromyalgia Syndrome

Keywords

fibromyalgia; exercise; telehealth; artificial intelligence

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (3)

• Pain Catastrophizing

  6 months

• Exercise adherence

  6 months

• Sociodemographic and Baseline Clinical Characteristics

  Week 0

Study Arms (3)

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.

Other: AI mobility

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.

Other: AI Combined (mobility and resistance training)

Usual Care

NO INTERVENTION

Continuation of usual care, including medical management, pharmacological treatment, and conventional physiotherapy when applicable.

Interventions

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

Also known as: AI exercise, Artificial Intelligence- and Computer Vision-Assisted Telerehabilitation

Arm 2: AI Combined (mobility and resistance training)

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

Also known as: AI Exercise

Arm 1: AI Mobility

Eligibility Criteria

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

You may qualify if:

• Adults aged 18 years or older, of any sex/gender, with a documented medical diagnosis of fibromyalgia established in primary or secondary healthcare settings according to the American College of Rheumatology (ACR) criteria (Häuser \& Fitzcharles, 2018).
• Individuals able to understand and complete the self-report questionnaires used in the study.
• Individuals with access to a compatible electronic device (smartphone, tablet, or computer) and an internet connection required for participation in the telerehabilitation intervention.
• Individuals with basic digital literacy skills, defined as the ability to use electronic devices and interact with commonly used applications.
• Individuals who provide written informed consent to participate in the study.

You may not qualify if:

• Current participation in another structured therapeutic exercise program, whether supervised or unsupervised.
• Moderate to severe functional dependence in activities of daily living, defined as a score \<60 on the Barthel Index.
• Absolute contraindications to therapeutic exercise, including hypertensive crisis (≥170/110 mmHg), dyspnea at rest, resting tachycardia, or severe glycemic abnormalities (blood glucose \>250 mg/dL or \<90 mg/dL in individuals receiving insulin therapy).
• Severe uncontrolled pain, defined as a score ≥8 on the Numeric Pain Rating Scale (NPRS) at rest.
• Medical or neurological conditions that significantly limit the safe performance of physical exercise, as determined by clinical assessment.
• Recent changes in fibromyalgia-specific pharmacological treatment within the previous 4 weeks, to ensure clinical stability throughout the intervention period.

Sponsors & Collaborators

• Instituto Neurociencia Del Dolor: lead
• Universidad San Sebastián: collaborator
• University of Alcala: collaborator

Related Publications (7)

• 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.

  PMID: 40090120 BACKGROUND

• 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.

  PMID: 35485547 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.

  PMID: 37184415 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.

  PMID: 39615810 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.

  PMID: 36893316 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.

  PMID: 27916278 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.

  PMID: 30586075 BACKGROUND

MeSH Terms

Conditions

Fibromyalgia; Motor Activity

Interventions

Range of Motion, Articular; Resistance Training; Aquatic Therapy; Artificial Intelligence

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Hydrotherapy; Algorithms; Mathematical Concepts

Study Officials

• Daniel Pecos Martín, PhD

  University of Alcala

  STUDY DIRECTOR

• José Manuel Gómez Pulido, PhD

  University of Alcala

  STUDY DIRECTOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: June 13, 2026
• First Posted: June 29, 2026
• Study Start (Estimated): January 4, 2027
• Primary Completion (Estimated): March 28, 2027
• Study Completion (Estimated): June 21, 2027
• Last Updated: July 1, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share