Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT07458971 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

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

Study acronym: ICF
StatusRecruiting
PhaseNot specified
Started2026-02-19
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 5 months later Apr 2026 → Oct 2026
Primary endpoint removed 25 → 24 primary endpoints
See other at-risk trials from Hacettepe University

Amendment history

2026-09-17
Recruitment opened
Primary endpoint(s) modified25 to 24 entries
WasEmotional Status (Hospital Anxiety and Depression Scale), Environmental Factors: Social Support and Ergonomic Adaptations, Grip Strength, Hand Disability (Turkish Thumb Disability Index - TDX), Joint Hypermobility (Beighton Score), Kinesiophobia Level (Tampa Scale of Kinesiophobia), LLM Prediction Accuracy for Categorical ICF Profiles, LLM Prediction Accuracy for Continuous ICF Profiles, Large Language Model Clinical Knowledge Accuracy, Large Language Model Clinical Relevance, Large Language Model Content Comprehensiveness, Large Language Model Readability Score, Large Language Model Response Reproducibility, Pain Beliefs Profile (Pain Beliefs Questionnaire), Pain Coping Strategies (Pain Coping Questionnaire)., Pain Duration, Pain Intensity, Pain-Activity Patterns (Patterns of Activity Measure-Pain)., Pinch Strength, Provocative Tests, Radial Subluxation Ratio, Radiographic Severity (Eaton-Littler Stage), Thumb Joint Range of Motion, Thumb Opposition (Kapandji Score), Upper Extremity Disability (QuickDASH)
NowEmotional Status (Hospital Anxiety and Depression Scale), Environmental Factors: Social Support and Ergonomic Adaptations, Grip Strength, Hand Disability (Turkish Thumb Disability Index - TDX), Joint Hypermobility (Beighton Score), Kinesiophobia Level (Tampa Scale of Kinesiophobia), LLM Prediction Accuracy for Categorical ICF Profiles, LLM Prediction Accuracy for Continuous ICF Profiles, Large Language Model Clinical Knowledge Accuracy, Large Language Model Clinical Relevance, Large Language Model Content Comprehensiveness, Large Language Model Readability Score, Pain Beliefs Profile (Pain Beliefs Questionnaire), Pain Coping Strategies (Pain Coping Questionnaire)., Pain Duration, Pain Intensity, Pain-Activity Patterns (Patterns of Activity Measure-Pain)., Pinch Strength, Provocative Tests, Radial Subluxation Ratio, Radiographic Severity (Eaton-Littler Stage), Thumb Joint Range of Motion, Thumb Opposition (Kapandji Score), Upper Extremity Disability (QuickDASH)
Primary completion pushed: 2026-04 → 2026-10
Completion moved earlier: 2027-07 → 2027-02
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.
Trial Details
NCT Number NCT07458971
Lead Sponsor Hacettepe University
Conditions Trapeziometacarpal Osteoarthritis, Thumb Osteoarthritis, Carpometacarpal Osteoarthritis, Thumb Basal Joint Osteoarthritis
Enrollment 93 participants
Start Date 2026-02-19
Primary Completion 2026-10 (estimated)
Study Completion 2027-02 (estimated)
Updated on ClinicalTrials.gov 2026-09-16