Systemic SclerodermaNCT07858838
Using AI-Assisted Cameras to Track Hand Exercises in Scleroderma Patients
A study testing AI-powered, camera-based, exercise-focused telerehabilitation and Physiotherapist-supervised, exercise-focused rehabilitation in people with Systemic Scleroderma, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Systemic Scleroderma
- What is being tested?
- AI-powered, camera-based, exercise-focused telerehabilitation and Physiotherapist-supervised, exercise-focused rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Nov 2026to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
İstanbul Üniversitesi-Cerrahpaşa Bakırköy Yerleşkesi
Istanbul, Bakirkoy, 34147
TUGBA CIVI KARAASLAN, PhD, 0902124141500, tugba.civi@iuc.edu.tr
About this study
Official title: 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.
- Conditions
- Systemic Scleroderma
- Being tested
- AI-powered, camera-based, exercise-focused telerehabilitation, Physiotherapist-supervised, exercise-focused rehabilitation
- Keywords
- Systemic Scleroderma, Motion Capture, Telerehabilitation, Hand Rehabilitation, Artificial Intelligence
- Medical subject headings
- Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-powered, camera-based, exercise-focused telerehabilitationOther
Also called AI-supervised exercise
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 rehabilitationOther
Also called Physiotherapist-supervised exercise
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: AI-powered, camera-based, exercise-focused telerehabilitation |
| 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/passive stretching components, aligned with the pathophysiology of SSc. Receives: Other: Physiotherapist-supervised, exercise-focused rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From enrollment to the end of treatment at 8 weeks
Secondary outcomes (8)
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).
Measured: From enrollment to the end of treatment at 8 weeks.
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).
Measured: From enrollment to the end of treatment at 8 weeks
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).
Measured: From enrollment to the end of treatment at 8 weeks
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.
Measured: From enrollment to the end of treatment at 8 weeks
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). 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).
Measured: From enrollment to the end of treatment at 8 weeks
Scleroderma Health Assessment Questionnaire - SHAQ
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
Measured: From enrollment to the end of treatment at 8 weeks
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.
Measured: From enrollment to the end of treatment at 8 weeks
the Semmes-Weinstein Monofilament (SWM) test
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.
Measured: From enrollment to the end of treatment at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic SclerodermaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pedram Shahriyari, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07858838
- Sponsor's protocol ID
- E130222603001711029
- Status last verified
- Sep 2026
- First submitted
- 29 Sep 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of an AI-Assisted Camera-Based Markerless Exercise Tracking System in Individuals With Scleroderma and Hand Involvement
- ClinicalTrials.gov ID
- NCT07858838
- Acronym / sponsor ID
- E130222603001711029
- Conditions
- Systemic Scleroderma
- Keywords
- Systemic Scleroderma, Motion Capture, Telerehabilitation, Hand Rehabilitation, Artificial Intelligence
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 5 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AI-Supported Telerehabilitation Group | Experimental | Other: AI-powered, camera-based, exercise-focused telerehabilitationVolunteers 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. |
| Physiotherapist-Supervised Traditional Rehabilitation Group | Active comparator | Other: Physiotherapist-supervised, exercise-focused rehabilitationParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AI-powered, camera-based, exercise-focused telerehabilitationAlso: AI-supervised exerciseBased 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 | AI-Supported Telerehabilitation Group |
| Physiotherapist-supervised, exercise-focused rehabilitationAlso: Physiotherapist-supervised exerciseParticipants 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 | Physiotherapist-Supervised Traditional Rehabilitation Group |
Primary outcome
Hand Mobility in Scleroderma (HAMIS)
Time frame: 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).
8 secondary outcomes
Universal Goniometer
Time frame: From enrollment to the end of treatment at 8 weeks.
Nine-Hole Peg Test - 9DPT
Time frame: From enrollment to the end of treatment at 8 weeks
Jamar-type dynamometer
Time frame: From enrollment to the end of treatment at 8 weeks
Michigan Hand Outcomes Questionnaire - MHQ
Time frame: From enrollment to the end of treatment at 8 weeks
Disabilities of the Arm, Shoulder and Hand - DASH
Time frame: From enrollment to the end of treatment at 8 weeks
Scleroderma Health Assessment Questionnaire - SHAQ
Time frame: From enrollment to the end of treatment at 8 weeks
System Usability Scale - SUS
Time frame: From enrollment to the end of treatment at 8 weeks
the Semmes-Weinstein Monofilament (SWM) test
Time frame: From enrollment to the end of treatment at 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI-powered, camera-based, exercise-focused telerehabilitation and Physiotherapist-supervised, exercise-focused rehabilitation in people with Systemic Scleroderma, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pedram Shahriyari, B.Sc (0905451368030, shpedram767@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hand Mobility in Scleroderma (HAMIS) (time frame: From enrollment to the end of treatment at 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.