About this trial
This study aims to develop and evaluate an AI-driven Personalized Exercise Feedback Program (AI-PEF) to enhance exercise adherence and 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 evaluates feasibility and acceptability through Delphi methods with expert consensus and patient feedback; Phase II validates preliminary outcomes with 30 participants in a 2-arm randomized trial; and Phase III assesses the program's impact on adherence, sleep quality, depressive symptoms, and quality of life with 90 participants in a 3-arm randomized trial.
Eligibility criteria
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- AI-PEF
- Theory-based digital exercise
- Active Control