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Using AI-Assisted Cameras to Track Hand Exercises in Scleroderma Patients

NCT07858838 · tracked via the Priya Life Science Turkey tracker
Phase
Not applicable
Started
2026-11
Last updated
2026-10-05

Condition(s) studied

Systemic Scleroderma

Investigational drug(s) / intervention(s)

AI-powered, camera-based, exercise-focused telerehabilitationPhysiotherapist-supervised, exercise-focused rehabilitation

AI-powered, camera-based, exercise-focused telerehabilitation: Based on machine learning and computer vision algorithms, this intervention can map twenty-one distinct anatomical reference points on the hand, wrist, and fingers in three-dimensional space in real-time, within milliseconds. The application utilizes movements previously validated for biomechanical accuracy by a physiotherapist; as the patient performs exercises at home, the system continuously compares their current range of motion (ROM) against reference values using algorithms. The patient receives immediate visual and auditory feedback on-screen regarding the accuracy, speed, and angle of the movement; simultaneously, the system creates an autonomous, asynchronous monitoring mechanism by automatically recording daily changes in ROM and session participation rates (treatment adherence) to a secure, cloud-based database.

Physiotherapist-supervised, exercise-focused rehabilitation: Participants in the control group will perform an eight-week specific hand exercise regimen-identical to that of the experimental group in terms of biomechanics, intensity, and physiological parameters-under the face-to-face supervision of a physiotherapist. The exercise protocol for both groups will consist of an evidence-based rehabilitation module incorporating isometric strengthening, flexor and extensor tendon gliding, and active/passive stretching components, aligned with the pathophysiology of SSc.

Study summary

The objective of this study is to investigate the effects of a camera-based, AI-supported markerless exercise tracking system on hand functions and psychosocial status in patients with Systemic Scleroderma (SSc), in comparison to a traditional face-to-face, physiotherapist-supervised exercise program.

It is hypothesized that the AI-based autonomous telerehabilitation intervention will yield statistically and clinically significant improvements in hand mobility, grip strength, and quality of life in SSc patients, achieving outcomes that are similar or superior to those of traditional in-clinic interventions.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria: * To ensure a specific, homogeneous study population devoid of external confounders, the primary inclusion criterion is a definitive diagnosis of "Systemic Sclerosis (SSc)" in accordance with the 2013 updated classification criteria established by the American College of Rheumatology (ACR) and the European League Against Rheumatism (EULAR). Furthermore, as the primary hypothesis of the study is centered on hand dysfunction, a mandatory criterion is that patients exhibit "clinically significant limitation of hand and finger mobility" as identified during a clinical examination by a specialist physician. This limitation must be secondary to dermal fibrosis, sclerodactyly, tendon friction rubs, or microvascular damage, and must be of sufficient severity to impair basic activities of daily living. This prerequisite is critically important to ensure the presence of a restorable motor deficit targeted by the technological intervention. Inclusion is restricted to individuals aged 18 to 65 years. The primary rationale for selecting this specific age bracket is twofold: to exclude the developmental variations inherent to the pediatric population (under 18 years) and to minimize the confounding effects of age-related idiopathic osteoarthritis, which is prevalent in the geriatric population (over 65 years) and can directly impact hand function. Additionally, this demographic window represents the age cohort with the optimal basic technological literacy and adaptive capacity requisite for utilizing home-based artificial intelligence software and interfaces. Pharmacological stability constitutes another paramount inclusion criterion to preserve the internal validity of the study. Prospective participants must not have undergone any major modifications to their regimens involving disease-modifying antirheumatic drugs (DMARDs), vasodilators (e.g., calcium channel blockers), or immunosuppressive therapies within the preceding three months (12 weeks). This requirement statistically ensures that any potential significant improvements observed in hand function, skin thickness, or microvascular perfusion over the eight-week rehabilitation period can be directly attributed to the implemented technological or traditional exercise interventions, rather than to alterations in medical therapy. Finally, specific cognitive and infrastructural competency prerequisites were incorporated into the inclusion criteria to ensure that participants can seamlessly integrate into the home-based technological intervention phase and effectively utilize the autonomous system. Patients are required to possess sufficient cognitive capacity, as well as adequate visual and auditory functions, to accurately perceive on-screen audio-visual commands, formulate motor plans, and execute them correctly. Concurrently, to enable the uninterrupted and synchronous execution of the artificial intelligence-supported exercise program in a home setting and to facilitate seamless data transfer to the cloud system, access to at least one personal computer or smart device, a standard webcam, and a stable internet connection is a fundamental condition for study inclusion. Exclusion Criteria: * Specific exclusion criteria were established because the acute systemic or local complications frequently encountered by scleroderma patients during the disease course could compromise the safety of the intensive motor intervention. Patients presenting with severe tissue ischemia in the hands, active digital ulceration (grade 3 depth or higher), fingertip gangrenous necrosis, or signs of active cutaneous or intra-articular infection severe enough to acutely impede the treatment process will be excluded from the study. The presence of an active infection or severe digital ulcers constitutes a contraindication for all physiotherapeutic interventions, as active hand exercises and stretching maneuvers may exacerbate local tissue damage, delay tissue healing, and disrupt the treatment process by exceeding the patient's pain tolerance. To ensure the study focuses exclusively on scleroderma-induced secondary hand impairments, major neurological and orthopedic pathologies that could affect hand and upper extremity functions via secondary mechanisms and independent pathophysiologies will be considered grounds for exclusion. Individuals who have undergone major orthopedic surgery of the upper extremity or wrist (e.g., flexor/extensor tendon repair, carpal tunnel release, or joint arthrodesis) within the past year will be excluded from the study cohort. Furthermore, to maintain the purity of the analysis, individuals with a history of comorbid neurological disorders that systemically impair manual dexterity-such as severe peripheral neuropathy, cerebrovascular accident (CVA), Parkinson's disease, cervical radiculopathy, or amyotrophic lateral sclerosis (ALS)-will not be included. In addition, patients diagnosed with severe primary osteoarthritis or rheumatoid arthritis in the hands will be excluded from the study to avoid confounding the etiology of their mobility limitations. Patients with advanced cardiopulmonary limitations that would preclude regular participation (e.g., advanced-stage pulmonary arterial hypertension causing dyspnea or interstitial lung disease) will also be excluded. To manage data attrition stemming from medical complications or absenteeism, patients who experience an acute exacerbation necessitating major adjustments to their medical regimen (e.g., changes in DMARD or immunosuppressive dosages) during the eight-week intervention period will be withdrawn from the study. Similarly, based on the analysis of technological system login data or clinical attendance records, individuals who demonstrate less than an 80% adherence rate to their prescribed intervention program (indicating treatment non-compliance) will be excluded during the per-protocol analysis phase, and their data will be omitted from the statistical evaluation.

Primary outcome measure(s)

  • Hand Mobility in Scleroderma (HAMIS) — From enrollment to the end of treatment at 8 weeks
    The HAMIS test encompasses nine distinct basic motor tasks: finger flexion and extension, thumb abduction, pincer grip, wrist volar and dorsal flexion, and forearm supination and pronation (2). Each movement is scored on a scale from 0 (full, normal range of motion) to 3 (inability to perform the movement), yielding a dysfunction score ranging from 0 to 27. The clinical utility of this test lies in its ability to detect cutaneous fibrosis and limitations in finger range of motion (ROM) with high accuracy (3).

Trial sites (1)

FacilityCityRegionStatus
İstanbul Üniversitesi-Cerrahpaşa Bakırköy Yerleşkesi Istanbul Bakirkoy
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07858838 on ClinicalTrials.gov ↗ ← All trials in Turkey