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

24 giugno 2026 aggiornato da: Instituto Neurociencia Del Dolor

Effectiveness of Artificial Intelligence- and Computer Vision-Assisted Telerehabilitation, With and Without Resistance Training, on Disease Impact and Physical Function in People With Fibromyalgia: A Randomized Controlled Trial (FibroIA 2.0)

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.

Panoramica dello studio

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

66

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: Romualdo Luciano Ordóñez Vega, Master, and PhD student
  • Numero di telefono: +56982256426
  • Email: kine.ordonez@gmail.com

Backup dei contatti dello studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Arm 1: AI Mobility
Mobility and stretching exercise program delivered through the Rehbody platform (AI/CV-assisted) in addition to usual care. The program includes seven specific exercises.

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

Altri nomi:
  • AI Exercise
Sperimentale: Arm 2: AI Combined (mobility and resistance training)
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.

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

Altri nomi:
  • AI exercise
  • Artificial Intelligence- and Computer Vision-Assisted Telerehabilitation
Nessun intervento: Usual Care
Continuation of usual care, including medical management, pharmacological treatment, and conventional physiotherapy when applicable.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Fibromyalgia Impact Questionnaire-Revised (FIQ-R)
Lasso di tempo: 6 months
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
Lasso di tempo: 6 months
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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Pain Catastrophizing
Lasso di tempo: 6 months
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).
6 months
Exercise adherence
Lasso di tempo: 6 months
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
Lasso di tempo: Week 0

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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Direttore dello studio: Daniel Pecos Martín, PhD, University of Alcala
  • Direttore dello studio: José Manuel Gómez Pulido, PhD, University of Alcala

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

4 gennaio 2027

Completamento primario (Stimato)

28 marzo 2027

Completamento dello studio (Stimato)

21 giugno 2027

Date di iscrizione allo studio

Primo inviato

13 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

24 giugno 2026

Primo Inserito (Effettivo)

29 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

29 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

24 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

it's not necessary

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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