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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Thumb Osteoarthritis; Trapeziometacarpal Osteoarthritis; Carpometacarpal Osteoarthritis; Thumb Basal Joint Osteoarthritis

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 93

Contacts and Locations

• Study Contact: Name: Tugba Ulusoy, MSc; Phone Number: +90 5075097351; Email: tugbaulusoy1@gmail.com

Study Locations

• Turkey (Türkiye)
  • Ankara, Turkey (Türkiye)
    • Recruiting
    • Hacettepe University, Faculty of Physical Therapy and Rehabilitation, Hand Surgery Rehabilitation Unit
    • Contact: Tugba Ulusoy, MSc; Phone Number: +90 5075097351; Email: tugbaulusoy1@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Individuals with trapeziometacarpal osteoarthritis referred to the Hand Surgery Rehabilitation Unit at Hacettepe University, Faculty of Physical Therapy and Rehabilitation, Ankara, Turkey.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
TMC OA Group; Individuals diagnosed with trapeziometacarpal osteoarthritis (TMC OA) by an orthopedic surgeon and/or hand surgeon, with symptoms persisting for more than 3 months, aged 25-74 years, referred to the Hand Surgery Rehabilitation Unit. All participants will undergo the same ICF-based comprehensive biopsychosocial assessment battery in a single face-to-face session.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Grip Strength	Measured using a Jamar dynamometer. The participant performs the test in a seated position with the elbow flexed at 90 degrees. Unit of Measure: Kilograms	Baseline (single assessment at enrollment)
Pinch Strength	Measured using a pinchmeter to assess tip-to-tip and key pinch strength. Unit of Measure: Kilograms	Baseline (single assessment at enrollment)
Thumb Opposition (Kapandji Score)	Assessment of thumb opposition using the Kapandji score, which ranges from 0 to 10. Higher scores indicate better thumb opposition and mobility.	Baseline (single assessment at enrollment)
Pain Intensity	Measured using a Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain intensity.	Baseline (single assessment at enrollment)
Pain Duration	Total duration of thumb pain reported by the participant.	Baseline (single assessment at enrollment)
Radiographic Severity (Eaton-Littler Stage)	Evaluation of the trapeziometacarpal joint osteoarthritis stage based on the Eaton-Littler classification (Stages I through IV).	Baseline (single assessment at enrollment)
Radial Subluxation Ratio	Radiographic measurement of the radial subluxation of the metacarpal base on the trapezium.	Baseline (single assessment at enrollment)
Upper Extremity Disability (QuickDASH)	Measured using the Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) questionnaire. The score ranges from 0 to 100, where higher scores indicate greater disability and symptoms.	Baseline (single assessment at enrollment)
Hand Disability (Turkish Thumb Disability Index - TDX)	Assessment of thumb-related disability. Scores range from 0 to 100, with higher scores indicating greater functional impairment.	Baseline (single assessment at enrollment)
Joint Hypermobility (Beighton Score)	Assessment of generalized joint laxity using the Beighton score. The total score ranges from 0 to 9, where higher scores indicate greater hypermobility.	Baseline (single assessment at enrollment)
Thumb Joint Range of Motion	Active range of motion of the thumb joints measured using a goniometer. Unit of Measure: Degrees	Baseline (single assessment at enrollment)
Provocative Tests	Clinical assessment using metacarpal adduction and extension tests to provoke symptoms. Presence or absence of pain (Binary: Yes/No)	Baseline (single assessment at enrollment)
Environmental Factors: Social Support and Ergonomic Adaptations	Qualitative assessment of the participant's family support and the presence of ergonomic adaptations in their daily environment.	Baseline (single assessment at enrollment)
Emotional Status (Hospital Anxiety and Depression Scale)	Measured using the Hospital Anxiety and Depression Scale (HADS), which consists of two subscales: Anxiety (HADS-A) and Depression (HADS-D). Each subscale ranges from 0 to 21, where higher scores indicate greater levels of anxiety or depression (worse outcome).	Baseline (single assessment at enrollment)
Kinesiophobia Level (Tampa Scale of Kinesiophobia)	Measured using the 17-item Tampa Scale of Kinesiophobia (TSK-17) to assess the fear of movement or re-injury. Total scores range from 17 to 68, where higher scores indicate greater kinesiophobia (worse outcome).	Baseline (single assessment at enrollment)
Pain-Activity Patterns (Patterns of Activity Measure-Pain).	Measured using the Patterns of Activity Measure-Pain (POAM-P) questionnaire to classify participants into three patterns: avoidance, overdoing, and pacing. Each subscale score indicates the frequency of that specific activity pattern. Higher scores on each subscale indicate a more frequent use of that specific activity pattern.	Baseline (single assessment at enrollment).
Pain Beliefs Profile (Pain Beliefs Questionnaire)	Assessed using the Pain Beliefs Questionnaire (PBQ), which evaluates two dimensions: Organic and Psychological pain beliefs. Scores range from 1 to 6 for each subscale, where higher scores indicate a stronger belief in that specific dimension (e.g., higher organic scores mean a stronger belief that pain is due to physical damage).	Baseline (single assessment at enrollment).
Pain Coping Strategies (Pain Coping Questionnaire).	Measured using the Pain Coping Questionnaire (PCQ) to assess the frequency of different coping strategies (e.g., information seeking, problem solving, distraction). Higher scores indicate a more frequent use of the respective coping strategy.	Baseline (single assessment at enrollment).
LLM Prediction Accuracy for Continuous ICF Profiles	Prediction accuracy of the best-performing LLM (identified in WP2) in estimating continuous clinical scores (e.g., Grip Strength, QuickDASH scores) from core clinical predictors. Accuracy will be measured using the Intraclass Correlation Coefficient (ICC) to evaluate the agreement between LLM-predicted values and actual clinical assessment results.	Within 3 months after the completion of clinical data collection.
LLM Prediction Accuracy for Categorical ICF Profiles	Prediction accuracy of the best-performing LLM in estimating categorical patient profiles (e.g., Eaton-Littler Stage, POAM-P activity patterns). Accuracy will be measured using Cohen's Kappa coefficient to evaluate the agreement between LLM-predicted categories and actual expert-diagnosed categories.	Within 3 months after the completion of clinical data collection.
Large Language Model Clinical Knowledge Accuracy	Accuracy of responses from four large language models to 40 patient-derived questions, each submitted under two prompting conditions (320 responses). Two blinded experts rate each response on an anchored 5-point scale (1 = mostly incorrect or potentially harmful, 5 = no factual error); criterion-level disagreements of two points or more are resolved by a third blinded expert. Higher scores indicate greater accuracy.	Baseline (single assessment during the data collection period)
Large Language Model Content Comprehensiveness	Coverage of the elements a specialist would expect in an answer, rated by two blinded experts on an anchored 5-point scale (1 = question not genuinely answered, 5 = all essential elements covered), with third-expert arbitration of disagreements of two points or more.	Baseline (single assessment at enrollment)
Large Language Model Clinical Relevance	Alignment of the response with the question asked, rated on an anchored 5-point scale (1 = unrelated, 5 = precisely and fully answers the question), with third-expert arbitration.	Baseline (single assessment)
Large Language Model Readability Score	Readability of generated responses, computed automatically as the Flesch Reading Ease score and the Flesch-Kincaid Grade Level. Higher Flesch Reading Ease scores indicate easier text; higher Flesch-Kincaid values indicate a higher required reading grade.	Baseline (calculated immediately after response generation)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlations Between Pain-Activity Patterns and Clinical Variables	This measure evaluates the correlation between the subscale scores of the Patterns of Activity Measure-Pain (POAM-P) questionnaire (Avoidance, Overdoing, and Pacing) and clinical parameters, including pain intensity (VAS), grip strength (kg), upper extremity disability (QuickDASH), and emotional status (HADS). Correlation will be analyzed using Spearman's or Pearson's correlation coefficients depending on the data distribution. Unit of Measure: Correlation Coefficient	Baseline (single assessment at enrollment)
Kinesiophobia Level (Tampa Kinesiophobia Scale)	Level of fear of movement or re-injury will be assessed using the unabbreviated 17-item Tampa Scale of Kinesiophobia (TSK-17). Total scores range from a minimum of 17 to a maximum of 68. Higher scores indicate a greater level of kinesiophobia (worse outcome).	Baseline (single assessment at enrollment).
Pain Beliefs Profile (Pain Beliefs Questionnaire)	This measure assesses the patients' beliefs about the cause of their pain using the unabbreviated Pain Beliefs Questionnaire (PBQ). The PBQ consists of two subscales: Organic Beliefs and Psychological Beliefs. Each subscale score is evaluated, and their correlation with coping strategies and emotional status is analyzed. For each subscale, scores range from 1 to 6 (calculated as an average of items), where higher scores indicate a stronger belief in that specific dimension (e.g., higher organic scores mean a stronger belief that pain has a physical cause).	Baseline (single assessment at enrollment)
Anxiety and Depression (Hospital Anxiety and Depression Scale)	Emotional status will be assessed using the Hospital Anxiety and Depression Scale (HADS). The scale consists of two subscales: HADS-Anxiety (HADS-A) and HADS-Depression (HADS-D). Each subscale ranges from 0 to 21, where higher scores indicate greater levels of anxiety or depression (worse outcome).	Baseline (single assessment at enrollment).
Pain Coping Strategies (Pain Coping Questionnaire)	Evaluation of the various methods used by participants to manage their pain using the unabbreviated Pain Coping Questionnaire (PCQ). The questionnaire assesses different subscales such as Information Seeking, Problem Solving, and Distraction. Each subscale is scored, and higher scores indicate a more frequent use of that specific coping strategy (higher scores generally represent better or more active coping, depending on the specific subscale).	Baseline (single assessment at enrollment)

Collaborators and Investigators

• Sponsor: Hacettepe University
• Investigators: Study Director: Cigdem Ayhan Kuru, Professor, Hacettepe University, Faculty of Physical Therapy and Rehabilitation

Study record dates

Study Major Dates

• Study Start (Actual): February 19, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: February 19, 2026
• First Submitted That Met QC Criteria: March 4, 2026
• First Posted (Actual): March 9, 2026

Study Record Updates

• Last Update Posted (Actual): September 16, 2026
• Last Update Submitted That Met QC Criteria: September 13, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Clinical Decision Support; ICF; Artificial Intelligence; Prediction Model; Large Language Model; Biopsychosocial Assessment; Trapeziometacarpal Joint; Pain-Activity Patterns
• Other Study ID Numbers: FTREK25/168

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified study data underlying the large language model component (Work Package 2), comprising all 320 model responses, expert ratings and analysis code, will be deposited in a public repository with a DOI at the time of publication.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No