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)
研究概览
地位
详细说明
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.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Romualdo Luciano Ordóñez Vega, Master, and PhD student
- 电话号码:+56982256426
- 邮箱:kine.ordonez@gmail.com
研究联系人备份
- 姓名:Marco Antonio Morales Osorio, PhD
- 电话号码:+56 9 3236 7359
- 邮箱:marco.morales.osorio@gmail.com
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
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.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的: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.
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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
其他名称:
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实验性的: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.
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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
其他名称:
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无干预:Usual Care
Continuation of usual care, including medical management, pharmacological treatment, and conventional physiotherapy when applicable.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Fibromyalgia Impact Questionnaire-Revised (FIQ-R)
大体时间:6 months
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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).
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6 months
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30-Second Sit-to-Stand Test (30s-STS) Performance
大体时间:6 months
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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).
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6 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Pain Catastrophizing
大体时间:6 months
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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
大体时间:6 months
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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).
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6 months
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Sociodemographic and Baseline Clinical Characteristics
大体时间:Week 0
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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
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合作者和调查者
调查人员
- 研究主任:Daniel Pecos Martín, PhD、University of Alcala
- 研究主任:José Manuel Gómez Pulido, PhD、University of Alcala
出版物和有用的链接
一般刊物
- 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.
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- FibroIA 2
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
药物和器械信息、研究文件
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