AI and Computer Vision-Assisted Telerehabilitation in Fibromyalgia: The FibroIA 2.0 Trial (fibroIA 2)

Instituto Neurociencia Del Dolor

Status: Begins enrollment in 3 months

Conditions: Fibromyalgia; Fibromyalgia (FM); Fibromyalgia Syndrome

Treatments: Other: AI mobility; Other: AI Combined (mobility and resistance training)

Study type: Interventional

Funder types: Other

Identifiers

NCT07674485

FibroIA 2

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 66 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

66 participants in 3 patient groups

Arm 1: AI Mobility

Experimental group

Description:

Mobility and stretching exercise program delivered through the Rehbody platform (AI/CV-assisted) in addition to usual care. The program includes seven specific exercises.

Treatment:

Other: AI mobility

Arm 2: AI Combined (mobility and resistance training)

Experimental group

Description:

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.

Treatment:

Other: AI Combined (mobility and resistance training)

Usual Care

No Intervention group

Description:

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