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.
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.
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.
Parallel
AI-powered, camera-based, exercise-focused telerehabilitation
Other interventionBased 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
Other interventionParticipants 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.
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).
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).
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.
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).
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.
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