An interventional study of AI Combined (mobility and resistance training) and AI mobility in Fibromyalgia, Fibromyalgia (FM) and Fibromyalgia Syndrome, sponsored by Instituto Neurociencia Del Dolor. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-01.
Sponsored by Instituto Neurociencia Del Dolor · Not applicable, Interventional, and Treatment
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.
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.
1,243 studies on the registry are indexed under Fibromyalgia; 256 are open to participants now.
This study's planned enrollment of 66 is close to the median of 60 across 937 interventional studies indexed under Fibromyalgia.
Browse Fibromyalgia studies →Instituto Neurociencia Del Dolor is the lead sponsor of 6 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Mobility and stretching exercise program delivered through the Rehbody platform (AI/CV-assisted) in addition to usual care. The program includes seven specific exercises.
Other: AI mobility
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.
Other: AI Combined (mobility and resistance training)
Continuation of usual care, including medical management, pharmacological treatment, and conventional physiotherapy when applicable.
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
Also known as: AI exercise, Artificial Intelligence- and Computer Vision-Assisted Telerehabilitation
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
Also known as: AI Exercise
Fibromyalgia Impact Questionnaire-Revised (FIQ-R)
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).
Time frame: 6 months
30-Second Sit-to-Stand Test (30s-STS) Performance
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).
Time frame: 6 months
Pain Catastrophizing
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).
Time frame: 6 months
Exercise adherence
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).
Time frame: 6 months
Sociodemographic and Baseline Clinical Characteristics
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.
Time frame: Week 0
No study locations are listed for this record.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — it's not necessary
Start is estimated for Jan 2027; primary completion for Mar 2027, 2 months later.
Of 436 non-industry interventional studies with no phase under Fibromyalgia, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 31. This study's planned 2 months is below that.
Counting every sponsor, half of 449 studies reached it within 15 months; a quarter within 6 and three quarters within 31.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Instituto Neurociencia Del Dolor