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

8 oktober 2026 bijgewerkt door: Pedram Shahriyari, Istanbul University - Cerrahpasa

Effectiveness of an AI-Assisted Camera-Based Markerless Exercise Tracking System in Individuals With Scleroderma and Hand Involvement

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.

Studie Overzicht

Studietype

Ingrijpend

Inschrijving (Geschat)

40

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

    • Bakirkoy
      • Istanbul, Bakirkoy, Turkije (Türkiye), 34147
        • İstanbul Üniversitesi-Cerrahpaşa Bakırköy Yerleşkesi
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 65 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

Definitive diagnosis of Systemic Sclerosis (SSc) according to the 2013 ACR/EULAR classification criteria

Clinically significant limitation of hand and finger mobility that impairs basic activities of daily living

Age between 18 and 65 years

Stable medical regimen (no major changes in DMARDs, vasodilators, or immunosuppressive therapies within the preceding 3 months)

Sufficient cognitive, visual, and auditory capacity to follow on-screen instructions

Access to a personal computer or smart device, a standard webcam, and a stable internet connection

Exclusion Criteria:

Active severe digital ulcers (grade 3 or higher), fingertip gangrene, severe tissue ischemia, or active hand infections

Major orthopedic surgery of the upper extremity or wrist within the past 1 year

Comorbid neurological disorders affecting hand function (e.g., severe peripheral neuropathy, stroke, Parkinson's disease, cervical radiculopathy, or ALS)

Severe primary osteoarthritis or rheumatoid arthritis of the hands

Advanced cardiopulmonary conditions precluding regular exercise participation (e.g., advanced pulmonary arterial hypertension or interstitial lung disease)

Inability to adhere to the 8-week intervention protocol

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ondersteunende zorg
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: AI-Supported Telerehabilitation Group

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.

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.

Andere namen:
  • AI-supervised exercise
Actieve vergelijker: Physiotherapist-Supervised Traditional Rehabilitation Group

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/passive stretching components, aligned with the pathophysiology of SSc.

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.

Andere namen:
  • Physiotherapist-supervised exercise

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Hand Mobility in Scleroderma (HAMIS)
Tijdsspanne: 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).

From enrollment to the end of treatment at 8 weeks

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Universal Goniometer
Tijdsspanne: From enrollment to the end of treatment at 8 weeks.

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.
Nine-Hole Peg Test - 9DPT
Tijdsspanne: From enrollment to the end of treatment at 8 weeks

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).

From enrollment to the end of treatment at 8 weeks
Jamar-type dynamometer
Tijdsspanne: From enrollment to the end of treatment at 8 weeks

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).

From enrollment to the end of treatment at 8 weeks
Michigan Hand Outcomes Questionnaire - MHQ
Tijdsspanne: From enrollment to the end of treatment at 8 weeks

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.

From enrollment to the end of treatment at 8 weeks
Disabilities of the Arm, Shoulder and Hand - DASH
Tijdsspanne: From enrollment to the end of treatment at 8 weeks

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). The DASH is a 30-item, self-administered questionnaire designed to measure physical function and symptoms in patients with musculoskeletal disorders of the upper limb. It assesses the patient's ability to perform specific daily activities, alongside the severity of pain, tingling, weakness, and the overall impact of the condition on social activities, work, and sleep. A score of 0 indicates no disability (best possible outcome), while a score of 100 indicates the most severe disability (worst possible outcome).

From enrollment to the end of treatment at 8 weeks
Scleroderma Health Assessment Questionnaire - SHAQ
Tijdsspanne: From enrollment to the end of treatment at 8 weeks

The SHAQ is a disease-specific, self-administered instrument used to evaluate functional disability and disease burden in patients with systemic sclerosis (scleroderma). It incorporates the standard 20-item Health Assessment Questionnaire Disability Index (HAQ-DI), which assesses difficulty in performing activities of daily living across 8 domains, combined with disease-specific Visual Analog Scales (VAS). These VAS components evaluate the severity of scleroderma-specific symptoms, including Raynaud's phenomenon, digital ulcers, gastrointestinal involvement, breathing difficulties, pain, and overall disease severity.

The standard HAQ-DI component is scored from 0 to 3. The disease-specific VAS items are typically scored on a 0 to 100 scale (or 0 to 150 mm, converted to a 0-3 scale depending on the specific trial methodology).

For both the HAQ-DI and VAS components, higher scores indicate greater functional impairment or more severe symptom burden (worst poss

From enrollment to the end of treatment at 8 weeks
System Usability Scale - SUS
Tijdsspanne: From enrollment to the end of treatment at 8 weeks

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.

From enrollment to the end of treatment at 8 weeks
the Semmes-Weinstein Monofilament (SWM) test
Tijdsspanne: From enrollment to the end of treatment at 8 weeks

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.

From enrollment to the end of treatment at 8 weeks

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 november 2026

Primaire voltooiing (Geschat)

1 april 2027

Studie voltooiing (Geschat)

1 mei 2027

Studieregistratiedata

Eerst ingediend

29 september 2026

Eerst ingediend dat voldeed aan de QC-criteria

29 september 2026

Eerst geplaatst (Werkelijk)

5 oktober 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

14 oktober 2026

Laatste update ingediend die voldeed aan QC-criteria

8 oktober 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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