NCT07010991

Brief Summary

In the context of this study, the 2nd and 3rd grade undergraduate students in Medipol University, Department of Physiotherapy and Rehabilitation, will taken into an education program to increase and assess their theoretical knowledge level, clinical decision-making skills and attitudes towards interactive learning with artificial intelligence by applying the ChatGPT-supported PBL module and the results will be compared with traditional teaching methods.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 14, 2025

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

May 30, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 8, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2025

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2025

Completed
Last Updated

June 8, 2025

Status Verified

May 1, 2025

Enrollment Period

4 months

First QC Date

May 30, 2025

Last Update Submit

May 30, 2025

Conditions

Keywords

StudentEducationArtificial intelligenceDecision Making

Outcome Measures

Primary Outcomes (2)

  • Theoretical knowledge test

    A 20-question multiple choice exam will be administered at the beginning of the study after the initial theoretical LBP course and at the end of the 2nd week of training, in total 3 times. With this way, distinguishing the effect of the lecturer's initial education and student's own studies and research will be possible at the analysis. The exams will be compared between groups to assess the intervention effect. The maximum score for the exam will be 100, and a score below 80 will be considered a failing grade.

    4 weeks

  • Mini Clinical Evaluation Exam (Mini-CEX)

    Participant's history taking, physical assessment and clinical reasoning skills will be observed by an independent assessor using the 9-point Mini-CEX form. Mini-CEX has been widely accepted as an effective and reliable method for assessing clinical skills. It includes student's ability to obtain a patient's history from the patient and family and to perform physical examinations under the guidance of an instructor. The Mini-CEX scoring system uses a nine-point scale and includes seven standards: medical interview skills, physical examination skills, humanistic qualities/professionalism, clinical judgment, counseling skills, organizational efficiency and general clinical competence. The scale ranges from inadequate (1-3 points), satisfactory (4-6 points) to superior (7-9 points). To maintain consistency, all Mini-CEX assessments will be made by a single assessor. The scale is valid and reliable in Turkish.

    4 weeks

Secondary Outcomes (4)

  • Student Satisfaction and Attitude Survey

    4 weeks

  • Young Internet Addiction Test

    4 weeks

  • Adult Reading Motivation Scale

    4 weeks

  • Artificial Intelligence Self-Efficacy Scale

    4 weeks

Study Arms (2)

ChatGPT supported problem-based learning

ACTIVE COMPARATOR

Students will be divided into small groups of 4-5 after the initial educative course of low back pain (LBP) by a different instructor. Afterwards, each group will work on chronic LBP case scenarios combined with ChatGPT. Students will engage in discussions on interactive learning, physical development planning, exercise recommendations, and biopsychosocial treatment development with ChatGPT. Data obtained from ChatGPT will be reviewed by the instructor for academic accuracy. Students will be actively involved in the discussion presentation and practice session. During the course, question sets created by students and answers obtained from ChatGPT are discussed within the group, prepared for class presentation and feedback is given by the instructor in terms of accuracy, timeliness and scientific relevance.

Other: AI based clinical problem solving education

Traditional learning group

ACTIVE COMPARATOR

Students will watch classical case presentations structured by the instructor and will passively/actively participate in discussions conducted on the case. Information transfer will be instructor-centered, ChatGPT or similar AI-supported tools will not be used in this group. Physical assessment and exercise practices will be carried out with the instructor's direct demonstration and students will take turns in the roles of practitioners or observers. Both groups will be provided with basic resource book chapters, videos and supporting materials on a weekly basis. The lessons will be conducted by an experienced physiotherapist academic and the groups will work with different instructor. Physical assessment and exercise practices will be carried out with the direct demonstration of the instructor, and students will take turns in the roles of practitioners and observers.

Other: Traditional Low Back Pain Education

Interventions

This direct involvement of AI and educators aims to improve learning outcomes by leveraging the scalability of AI and the expertise of educators. The question sets created by students and the answers obtained from ChatGPT are discussed within the group and prepared for class presentation, and the instructor provides feedback on accuracy, timeliness, and scientific relevance. This process aims to support students' participation as active questioners and analyzers, rather than passive consumers of information. Intervention will last for 2 weeks, 2 hours of courses each week, in total 4 hours of education will be given. First 2 hours will be the usage parameters and the knowledge about the ChatGPT system and the 2nd week's 2 hours of education will include the presentations and interactive discussion about the case.

ChatGPT supported problem-based learning

The first session will be given by an independent/different instructor about the definition, reasons, evaluation and the treatment of low back pain for 2 hours. Afterwards the students will be informed about the content of the next week's interactive course and supplied with the study sources like book, articles by the other lecturer. A week will be given to the students to study and the other week they will meet with the lecturer to discuss over a specific case. At the beginning and end of the courses, outcome measures will taken from the both groups.

Traditional learning group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Being an undergraduate student
  • Being voluntary to attend to the courses

You may not qualify if:

  • Not attending to the sessions on time
  • Being a 4th grade student who already took and learned the process of clinical problem solving
  • Want to recruit to study during the study process

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medipol University İstanbul

Istanbul, Kavacık Beykoz, 34810, Turkey (Türkiye)

RECRUITING

Related Publications (1)

  • Ergezen Sahin G, Aras Bayram G, Sanchez Sierra A, Akdemir S, Kurc D, Tarakci D, Tunali AN. Effects of artificial intelligence based physiotherapy educational approach in developing clinical reasoning skills: a randomized controlled trial. BMC Med Educ. 2025 Oct 9;25(1):1378. doi: 10.1186/s12909-025-07926-w.

Study Officials

  • Gülay ARAS BAYRAM, Associate Professor

    Medipol University İstanbul

    STUDY DIRECTOR

Central Study Contacts

Simay AKDEMİR, MSc./Lec.

CONTACT

Gizem ERGEZEN ŞAHİN, Dr. Lec.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Different educators will be giving the educative courses to the groups without knowing the participants of the other group. And one independent observer will observe the student's decision making processes during the courses.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: A prospective, randomized, controlled educational intervention study to be conducted with the participation of undergraduate students. Participants will be divided into two groups as ChatGPT supported problem-based learning and traditional learning group and will be included in a total of 4 hours of training process on chronic low back pain and rehabilitation, 2 hours per week for 2 weeks. 40 students will be included in the study based on voluntary participation. Basic demographic, academic and technological competence information will be collected from the students who will participate in the study. Collected data will be used to assess equality in comparisons between groups, to define sample characteristics, and to support subgroup analyses when necessary. Students will be divided into small groups of 4-5 people after the initial LBP course and will be asked to study for week and actively participate in the discussion presentations and practice session the following week.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc. Lecturer Physical Therapist

Study Record Dates

First Submitted

May 30, 2025

First Posted

June 8, 2025

Study Start

May 14, 2025

Primary Completion

August 31, 2025

Study Completion

September 10, 2025

Last Updated

June 8, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

This will our own study design conducted by the lecturers in our department. Therefor the IPD will not be shared with the other researchers.

Locations