NCT07458971 ICF-Based Biopsychosocial Assessment With AI-Assisted Profile Prediction: Trapeziometacarpal Osteoarthritis Model
| NCT ID | NCT07458971 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hacettepe University |
| Condition | Trapeziometacarpal Osteoarthritis |
| Study Type | OBSERVATIONAL |
| Enrollment | 93 participants |
| Start Date | 2026-02-19 |
| Primary Completion | 2026-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 93 participants in total. It began in 2026-02-19 with a primary completion date of 2026-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Trapeziometacarpal osteoarthritis (TMC OA) is a common condition affecting the base of the thumb that causes pain, weakness, and difficulty with daily hand use. Current clinical assessment often focuses on physical findings alone, without considering psychological and social factors that also influence patient outcomes. This study has three objectives organized as interrelated work packages: OBJECTIVE 1 (Clinical Assessment): To comprehensively assess individuals with TMC OA using the International Classification of Functioning, Disability and Health (ICF) framework. This includes evaluating pain, joint mobility, grip strength, daily activity limitations, social participation, psychological factors (anxiety, depression, fear of movement, pain beliefs), and environmental factors (family support, ergonomic adaptations). OBJECTIVE 2 (AI Knowledge Evaluation): To compare the performance of four large language models (GPT-5.2, Claude Opus 4.6, Gemini 2.5 Pro, LLaMA 4 Maverick) in answering patient questions about TMC OA, and to test whether adding a clinician-oriented system prompt changes that performance. Each question is submitted under two prompting conditions (zero-shot and clinician-oriented system prompt) and responses are rated by blinded experts for accuracy, comprehensiveness and clinical relevance, with readability assessed by automated indices. OBJECTIVE 3 (AI-Based Prediction): To analyze whether the best-performing large language model can predict multidimensional ICF-based patient profiles using only a limited set of core clinical parameters.
Eligibility Criteria
Inclusion Criteria: * Diagnosis of trapeziometacarpal osteoarthritis (TMC OA) confirmed by an orthopedic surgeon and/or hand surgeon * TMC OA-related symptoms persisting for more than 3 months * Aged between 25 and 74 years * Literate in Turkish * Adequate cognitive function (Mini-Mental State Examination score of 25 or above) * No other chronic systemic disease (e.g., rheumatoid arthritis, chronic diabetes, cardiovascular disease, chronic hepatitis) * Voluntary participation with signed informed consent Exclusion Criteria: * Unwillingness to participate * Presence of a different orthopedic condition or prior surgery involving the thumb on the unilateral upper extremity * Uncontrolled systemic diseases (chronic obstructive pulmonary disease, congestive heart failure, endocrine system disease, history of stroke) * Diagnosis of any major psychopathology and currently receiving psychiatric or psychological treatment * Pregnancy
Contact & Investigator
Cigdem Ayhan Kuru, Professor
STUDY DIRECTOR
Hacettepe University, Faculty of Physical Therapy and Rehabilitation
Frequently Asked Questions
Who can join the NCT07458971 clinical trial?
This trial is open to participants of all sexes, aged 25 Years or older, up to 74 Years, studying Trapeziometacarpal Osteoarthritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07458971 currently recruiting?
Yes, NCT07458971 is actively recruiting participants. Contact the research team at tugbaulusoy1@gmail.com for enrollment information.
Where is the NCT07458971 trial being conducted?
This trial is being conducted at Ankara, Turkey (Türkiye).
Who is sponsoring the NCT07458971 clinical trial?
NCT07458971 is sponsored by Hacettepe University. The principal investigator is Cigdem Ayhan Kuru, Professor at Hacettepe University, Faculty of Physical Therapy and Rehabilitation. The trial plans to enroll 93 participants.