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NCT06817564
AI-driven Personalized Exercise Feedback Program on Exercise Adherence in Traumatic Brain Injury
NA trial testing AI-PEF in Traumatic Brain Injury in 125 participants. Not yet recruiting.
31 December 2030
Quick facts
| Lead sponsor | National Defense Medical Center, Taiwan |
|---|---|
| Phase | NA |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | supportive care |
| Enrollment | 125 |
| Start date | 1 March 2025 |
| Primary completion | 31 December 2030 |
| Estimated completion | 31 August 2031 |
Drugs / interventions tested
- AI-PEF
- Theory-based digital exercise
- Active Control — full drug profile →
Conditions studied
- Traumatic Brain Injury — all drugs for Traumatic Brain Injury →
- Exercise — all drugs for Exercise →
- AI (Artificial Intelligence) — all drugs for AI (Artificial Intelligence) →
- Digital Health — all drugs for Digital Health →
Sponsor
National Defense Medical Center, Taiwan
Who can join
18 and older, any sex, with Traumatic Brain Injury or Exercise. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06817564
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06817564 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by National Defense Medical Center, Taiwan
- Last refreshed: 12 February 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06817564.
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