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
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Pedram Shahriyari, B.Sc
- Phone Number: 0905451368030
- Email: shpedram767@gmail.com
Study Locations
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Bakirkoy
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Istanbul, Bakirkoy, Turkey (Türkiye), 34147
- İstanbul Üniversitesi-Cerrahpaşa Bakırköy Yerleşkesi
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Contact:
- TUGBA CIVI KARAASLAN, PhD
- Phone Number: 0902124141500
- Email: tugba.civi@iuc.edu.tr
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: 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.
Other Names:
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Active Comparator: 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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Hand Mobility in Scleroderma (HAMIS)
Time Frame: From enrollment to the end of treatment at 8 weeks
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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
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Universal Goniometer
Time Frame: From enrollment to the end of treatment at 8 weeks.
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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.
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Nine-Hole Peg Test - 9DPT
Time Frame: From enrollment to the end of treatment at 8 weeks
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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
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Jamar-type dynamometer
Time Frame: From enrollment to the end of treatment at 8 weeks
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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
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Michigan Hand Outcomes Questionnaire - MHQ
Time Frame: From enrollment to the end of treatment at 8 weeks
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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
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Disabilities of the Arm, Shoulder and Hand - DASH
Time Frame: From enrollment to the end of treatment at 8 weeks
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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
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Scleroderma Health Assessment Questionnaire - SHAQ
Time Frame: From enrollment to the end of treatment at 8 weeks
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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
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System Usability Scale - SUS
Time Frame: From enrollment to the end of treatment at 8 weeks
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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
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the Semmes-Weinstein Monofilament (SWM) test
Time Frame: From enrollment to the end of treatment at 8 weeks
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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
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- E130222603001711029
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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