- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07674485
AI and Computer Vision-Assisted Telerehabilitation in Fibromyalgia: The FibroIA 2.0 Trial (fibroIA 2)
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)
Přehled studie
Postavení
Intervence / Léčba
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
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Romualdo Luciano Ordóñez Vega, Master, and PhD student
- Telefonní číslo: +56982256426
- E-mail: kine.ordonez@gmail.com
Studijní záloha kontaktů
- Jméno: Marco Antonio Morales Osorio, PhD
- Telefonní číslo: +56 9 3236 7359
- E-mail: marco.morales.osorio@gmail.com
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
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
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:
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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:
|
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Žádný zásah: Usual Care
Continuation of usual care, including medical management, pharmacological treatment, and conventional physiotherapy when applicable.
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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).
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6 months
|
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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
Sponzor
Vyšetřovatelé
- Ředitel studie: Daniel Pecos Martín, PhD, University of Alcala
- Ředitel studie: José Manuel Gómez Pulido, PhD, University of Alcala
Publikace a užitečné odkazy
Obecné publikace
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Nemoci pohybového aparátu
- Nemoci nervového systému
- Svalová onemocnění
- Neuromuskulární onemocnění
- Revmatická onemocnění
- Chování
- Fibromyalgie
- Motorická aktivita
- Motorická aktivita
- Hnutí
- Muskuloskeletální fyziologické jevy
- Muskuloskeletální a nervové fyziologické jevy
- Terapeutika
- Diagnostické techniky a postupy
- Diagnóza
- Modality fyzikální terapie
- Péče o pacienty
- Cvičební terapie
- Rehabilitace
- Následná péče
- Kontinuita péče o pacienty
- Fyzická kondicionování, člověk
- Cvičení
- Fyzické vyšetření
- Algoritmy
- Matematické koncepty
- Hydroterapie
- Trénink odporu
- Rozsah pohybu, kloubní
- Umělá inteligence
- Vodoléčba
Další identifikační čísla studie
- FibroIA 2
Plán pro data jednotlivých účastníků (IPD)
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Popis plánu IPD
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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