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

28. června 2026 aktualizováno: 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.

Přehled studie

Detailní popis

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.

Typ studie

Intervenční

Zápis (Odhadovaný)

66

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

  • Jméno: Romualdo Luciano Ordóñez Vega, Master, and PhD student
  • Telefonní číslo: +56982256426
  • E-mail: kine.ordonez@gmail.com

Studijní záloha kontaktů

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Singl

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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

Ostatní jména:
  • AI Exercise
Experimentální: 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

Ostatní jména:
  • AI exercise
  • Artificial Intelligence- and Computer Vision-Assisted Telerehabilitation
Žádný zásah: Usual Care
Continuation of usual care, including medical management, pharmacological treatment, and conventional physiotherapy when applicable.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Fibromyalgia Impact Questionnaire-Revised (FIQ-R)
Časové okno: 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
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Pain Catastrophizing
Časové okno: 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
Časové okno: 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
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Vyšetřovatelé

  • Ředitel studie: Daniel Pecos Martín, PhD, University of Alcala
  • Ředitel studie: José Manuel Gómez Pulido, PhD, University of Alcala

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

4. ledna 2027

Primární dokončení (Odhadovaný)

28. března 2027

Dokončení studie (Odhadovaný)

21. června 2027

Termíny zápisu do studia

První předloženo

13. června 2026

První předloženo, které splnilo kritéria kontroly kvality

24. června 2026

První zveřejněno (Aktuální)

29. června 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

1. července 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

28. června 2026

Naposledy ověřeno

1. června 2026

Více informací

Termíny související s touto studií

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Popis plánu IPD

it's not necessary

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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