[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658954":3},{"organization":4,"outcomesModule":7,"designInfo":37,"detailedDescription":36,"studyPopulation":36,"armGroups":45,"interventions":58,"overallOfficials":36,"centralContacts":71,"locations":77,"responsibleParty":95,"collaborators":36,"id":99,"slug":100,"hasResults":101,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":36,"eligibilityCriteria":105,"healthyVolunteers":101,"sex":106,"minAge":107,"maxAge":108,"enrollmentInfo":109,"targetDuration":36,"studyType":112,"phases":113,"briefSummary":115,"conditions":116,"keywords":118,"overallStatus":123,"whyStopped":36,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":133},{"fullName":5,"class":6},"Istanbul University - Cerrahpasa","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":36},[9],{"measure":10,"description":11,"timeFrame":12},"Hand Mobility in Scleroderma (HAMIS)","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).","From enrollment to the end of treatment at 8 weeks",[14,18,21,24,27,30,33],{"measure":15,"description":16,"timeFrame":17},"Universal Goniometer","To determine the extent of flexor tendon contractures-commonly observed in scleroderma patients due to excessive collagen accumulation-and the severity of sclerodactyly, the distance between the fingertips (pulp) and the distal palmar crease will be measured both actively and passively in centimeters (cm) using a standard metric ruler. Biomechanically, a value of 0 cm (indicating full contact of the fingertip pulp with the palmar crease) is expected during the full range of finger flexion; positive values directly reflect flexor system dysfunction and joint contracture. The literature indicates that this measurement method is practical, time-efficient, and highly reliable for clinical monitoring and for assessing joint motion in cases of restricted digital movement (particularly when combined with goniometry).","From enrollment to the end of treatment at 8 weeks.",{"measure":19,"description":20,"timeFrame":12},"Nine-Hole Peg Test - 9DPT","The test is based on the principle of the patient sequentially inserting pegs (small rods) into nine holes on a wooden or plastic board of standard dimensions and then rapidly removing them (6). The test begins with the dominant hand, and the time taken for patients to insert and remove all pegs is recorded in seconds using a stopwatch (7). Additionally, the Semmes-Weinstein Monofilament (SWM) test will be used to assess cutaneous sensory loss that may develop secondary to SSc-specific microvascular ischemic damage, digital ulcerations, or neural compression. Nylon monofilaments of varying thicknesses and calibrated buckling forces are applied to the patient's fingertips for 1-1.5 seconds, using enough pressure to create a slight bend (C-shape). In the assessment of tactile sensation, force values between 1.65 and 2.83 are reported as \"normal\" touch sensation (8), and this test is a validated method for detecting somatosensory impairment caused by cutaneous fibrosis in sensory tissue.",{"measure":22,"description":23,"timeFrame":12},"Jamar-type dynamometer","Gross hand grip strength will be measured three consecutive times using a Jamar dynamometer-with the patient in a seated position, the shoulder adducted, and the elbow flexed at 90 degrees and held against the trunk-and the average value will be recorded in the system in kilograms (kg) or pounds (lbs).",{"measure":25,"description":26,"timeFrame":12},"Michigan Hand Outcomes Questionnaire - MHQ","This questionnaire is a comprehensive, six-dimensional, 57-item tool that specifically assesses not only physical functions but also activities of daily living, work performance, pain, aesthetic perception, and patient satisfaction (9). The MHQ score is normalized to a range of 0 to 100; higher scores in dimensions other than pain indicate a better clinical status and increased functionality.",{"measure":28,"description":29,"timeFrame":12},"Disabilities of the Arm, Shoulder and Hand - DASH","The Turkish cultural adaptation and validation of the DASH-which consists of 30 items and is scored on a scale of 0 to 100 (with higher scores indicating greater disability)-were introduced to the literature by Düger et al. (2006) (ICC: 0.910).",{"measure":31,"description":32,"timeFrame":12},"Scleroderma Health Assessment Questionnaire - SHAQ","SHAQ is a complex, disease-specific assessment tool created by adding five SSc-specific Visual Analog Scale (VAS) items-Raynaud's phenomenon severity, impact of digital ulcers, overall disease severity, respiratory limitation, and bowel involvement-to the traditional HAQ disability index (HAQ-DI), which is widely used in rheumatology.",{"measure":34,"description":35,"timeFrame":12},"System Usability Scale - SUS","Consisting of a total of 10 items, this scale rapidly and reliably measures the perceived usability of digital interfaces and interactive systems. The Turkish validity and reliability study of the scale (SUS-TR) was conducted by Demirkol and Şeneler (2018), demonstrating that, with its two-factor structure, it is a valid and highly reliable psychometric tool for Turkish users. The scale comprises Likert-type questions scored from 1 to 5; the resulting scores are converted into a 0-100 point scale for interpretation, with higher scores indicating high system usability. This tool enables an objective analysis of the technological real-time feedback system's usability from the patient's perspective.",null,{"allocation":38,"interventionModel":39,"interventionModelDescription":36,"primaryPurpose":40,"observationalModel":36,"timePerspective":36,"maskingInfo":41},"RANDOMIZED","PARALLEL","SUPPORTIVE_CARE",{"masking":42,"maskingDescription":36,"whoMasked":43},"SINGLE",[44],"OUTCOMES_ASSESSOR",[46,52],{"label":47,"type":48,"description":49,"interventionNames":50},"AI-Supported Telerehabilitation Group","EXPERIMENTAL","Volunteers assigned to the experimental group within the scope of the study will use an AI-integrated, markerless telerehabilitation system that operates with a standard mobile or web camera and requires no external wearable sensors, markers, or complex hardware.",[51],"Other: AI-powered, camera-based, exercise-focused telerehabilitation",{"label":53,"type":54,"description":55,"interventionNames":56},"Physiotherapist-Supervised Traditional Rehabilitation Group","ACTIVE_COMPARATOR","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 to be administered to both groups will consist of an evidence-based rehabilitation module comprising isometric strengthening, flexor and extensor tendon gliding, and active\u002Fpassive stretching components, aligned with the pathophysiology of SSc.",[57],"Other: Physiotherapist-supervised, exercise-focused rehabilitation",[59,65],{"type":6,"name":60,"description":61,"armGroupLabels":62,"otherNames":63},"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.",[47],[64],"AI-supervised exercise",{"type":6,"name":66,"description":67,"armGroupLabels":68,"otherNames":69},"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\u002Fpassive stretching components, aligned with the pathophysiology of SSc.",[53],[70],"Physiotherapist-supervised exercise",[72],{"name":73,"role":74,"phone":75,"phoneExt":36,"email":76},"Pedram Shahriyari, B.Sc","CONTACT","0905451368030","shpedram767@gmail.com",[78],{"facility":79,"status":36,"city":80,"state":81,"zip":82,"country":83,"countryCode":36,"cosmosGeoPoint":84,"geoPoint":89,"contacts":90},"İstanbul Üniversitesi-Cerrahpaşa Bakırköy Yerleşkesi","Istanbul","Bakirkoy","34147","Turkey (Türkiye)",{"type":85,"coordinates":86},"Point",[87,88],28.94966,41.01384,{"lat":88,"lon":87},[91],{"name":92,"role":74,"phone":93,"phoneExt":36,"email":94},"TUGBA CIVI KARAASLAN, PhD","0902124141500","tugba.civi@iuc.edu.tr",{"type":96,"investigatorFullName":97,"investigatorTitle":98,"investigatorAffiliation":5,"oldNameTitle":36,"oldOrganization":36},"PRINCIPAL_INVESTIGATOR","Pedram Shahriyari","Physiotherapist","100658954","using-ai-assisted-cameras-to-track-hand-exercises-in-scleroderma-patients-100658954",false,"NCT07858838","Using AI-Assisted Cameras to Track Hand Exercises in Scleroderma Patients","Effectiveness of an AI-Assisted Camera-Based Markerless Exercise Tracking System in Individuals With Scleroderma and Hand Involvement","Inclusion Criteria:\n\n* 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.\n\nInclusion 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.\n\nPharmacological 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.\n\nFinally, 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.\n\nExclusion Criteria:\n\n* 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.\n\nTo 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\u002Fextensor 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.\n\nPatients 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.\n\nTo 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.","ALL","18 Years","65 Years",{"count":110,"type":111},60,"ESTIMATED","INTERVENTIONAL",[114],"NA","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.\n\nIt 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.",[117],"Systemic Scleroderma",[117,119,120,121,122],"Motion Capture","Telerehabilitation","Hand Rehabilitation","Artificial Intelligence","NOT_YET_RECRUITING","2026-09-29",{"date":126,"type":127},"2026-10-05","ACTUAL",{"date":129,"type":111},"2026-11",{"date":131,"type":111},"2027-05",{"name":5,"class":6},1]