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ICF-Based Biopsychosocial Assessment With AI-Assisted Profile Prediction: Trapeziometacarpal Osteoarthritis Model

ICF-Based Biopsychosocial Assessment With AI-Assisted Profile Prediction: Trapeziometacarpal Osteoarthritis Model

Recruiting
25-74 years
All
Phase N/A

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Overview

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.

Description

This research consists of three independent but interrelated work packages with different methods and targets.

Work Package 1 (Clinical Data Collection and ICF-Based Profile Analysis): Participants with TMC OA will undergo a single face-to-face comprehensive assessment using a cross-sectional design. The assessment battery is structured according to the ICF framework and covers five domains: (a) Body Structure/Function: pain, joint mobility, grip and pinch strength, joint stability, and OA staging; (b) Activity: daily activity limitations and pain-activity patterns (avoidance, overdoing, pacing); (c) Participation: social, domestic, and occupational participation; (d) Personal Factors: pain beliefs, coping strategies, kinesiophobia, anxiety, and depression; (e) Environmental Factors: family support and ergonomic adaptations.

Work Package 2 (Comparison of Large Language Models' Clinical Knowledge Performance): Forty patient questions derived from search-engine "People Also Ask" data are submitted programmatically, through provider application programming interfaces, to four large language models (GPT-5.2, Claude Opus 4.6, Gemini 2.5 Pro, LLaMA 4 Maverick) under two prompting conditions: zero-shot, and with a clinician-oriented system prompt. This yields 320 responses. Two experts (a hand therapist and a hand surgeon), blinded to model identity and prompting condition, independently rate each response for accuracy, comprehensiveness and clinical relevance on anchored 5-point scales. Criterion-level disagreements of two points or more are referred to a third blinded hand surgeon, whose rating is substituted for that criterion. Readability is computed automatically as Flesch Reading Ease and Flesch-Kincaid Grade Level.

Work Package 3 (LLM-Based Predictive Profile Modeling): The best-performing LLM identified in WP2 will be provided with core clinical predictors from WP1 data. The model's predictions for multidimensional ICF-based patient profiles will be compared against actual assessment results using established agreement and performance metrics.

Sample size: Based on a priori power analysis (alpha=0.05, power=0.80, effect size=0.131), a minimum of 93 participants is required.

Eligibility

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

Study details
    Trapeziometacarpal Osteoarthritis
    Thumb Osteoarthritis
    Carpometacarpal Osteoarthritis
    Thumb Basal Joint Osteoarthritis

NCT07458971

Hacettepe University

19 September 2026

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