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AI-driven Personalized Exercise Feedback Program on Exercise Adherence in Traumatic Brain Injury

StatusNot Yet Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoints added 5 → 20 primary endpoints
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Record History

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  1. Re-verified, no change to tracked fieldsv4
  2. Primary endpoint(s) modifiedv3 Show 4 more changesShow less
    • Start date: Mar 1, 2025 to Aug 17, 2026
    • Secondary endpoints: 70 to 55
    • Study description expanded, about 72 words
    • Eligibility criteria shortened, about 2 words
  3. Secondary endpoints: details revised at 18 of 70 entries
    • Eligibility criteria shortened, about 3 words
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 exercise adherence, exercise motivation, mHealth app usability, functional capacity, sleep quality, depressive symptoms, concussion symptoms, and quality of life with 90 participants in a 3-arm randomized trial. In Phase III, quantitative and qualitative data will be collected in parallel, with qualitative data collected through semi-structured interviews to explore participants' experiences and perceptions of the intervention.
Trial Details
NCT Number NCT06817564
Lead Sponsor National Defense Medical Center, Taiwan
Conditions
(from sponsor)		 Traumatic Brain Injury, Exercise, AI (Artificial Intelligence), Digital Health
Related terms Brain Injuries, Traumatic, Motor Activity
Enrollment 125 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov