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RECRUITING Not applicable ClinicalTrials.gov

AI Chatbot-Assisted Aerobic Exercise Guided by the Transtheoretical Model and Self-determination Theory With Machine Learning Algorithms to Provide Real-time, Personalized Feedback in Traumatic Brain Injury

Sponsor: National Defense Medical Center, Taiwan • ClinicalTrials.gov ID: NCT07783828

Registry updated: 2026-08-25
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Description

This study aims to develop and evaluate an AI-driven Personalized Exercise Feedback Program (AI-PEF) to enhance health outcomes in mTBI patients. Methods: AI-PEF integrates the transtheoretical model and self-determination theory with machine learning algorithms to provide real-time, personalized feedback. A phased randomized controlled trial will be conducted: Phase I,small-Scale Pilot Study (Early Feedback): A single-arm pilot study with 5 patients will be conducted over four weeks to gather feedback on usability, engagement, and content clarity.Phase II assesses the program's impact on functional capacity, sleep quality and depressive symptoms, with 50 participants in a 2-arm randomized trial in 3 months.Phase III will assess the program's impact on functional capacity, sleep quality and depressive symptoms, with 50 participants of waitlist control evaluation in a two-arm randomized trial.

Interventions

  • AI-PEF (Behavioral)
    Participants will follow a 6months walking program with five 30-minute sessions per week, progressively increasing intensity based on heart rate and effort indices. Garmin fitness trackers will monitor adherence and intensity. Remote guidance will support participants via weekly digital health messages on the LINE app, offering personalized feedback, goal reinforcement, and lifestyle recommendations. Participants will also receiThese AI feedback implementations will be tailored to complement the in-person education and will include reminders of the individualized goals set during the remote exercise intervention and consultation . The digital component will also offer a platform for patients to share their progress and seek further guidance during the scheduled in-person consultation. The use of digital AI feedback aligns with the trend of integrating technology into healthcare services, providing a convenient and accessible modality for supporting parents engaging in regular exercise.
  • Active Control (Behavioral)
    Participants in the active control group will receive standard TBI care, including Garmin-based self-monitoring and routine clinic visits at baseline (T0), 1 months (T1), 2months(T2),and 3 months (T3). These visits will include general health education and recommendations on daily physical activity. No personalized or digital exercise strategies will be provided. Participants completing the 3-month protocol will have the option to access the AI-PEF program. When active control group participants completing the 3-month protocol will have the option to access the AI-PEF program.Then participants will use AI-PEF program to be the waitlist control group after 3 months to 6months, with assessments conducted at 6 months (T4).

Eligibility criteria

Inclusion Criteria: * Eligible participants are patients aged over 18 with mild TBI (GCS 13-15) * who can walk independently, * reside in the Greater Taipei area, * and possess sufficient Chinese or Taiwanese language proficiency to understand the trial * complete self-administered questionnaires. Exclusion Criteria: include individuals with severe medical conditions (e.g., respiratory failure, epilepsy, psychiatric disorders), musculoskeletal or neurological impairments * hindering physical activity in the 6-minute walk test, * cognitive impairments (MMSE \< 24), * frontal lobe injuries or penetrating injury causing significant psychological dysfunction. * Patients regularly engaging in moderate-to-high-intensity aerobic exercise or participating in other studies will also be excluded to avoid bias.

Conditions

Tramatic Brain Injury

Locations

  • Tri-Service General Hospital — Taipei, Taiwan
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record