Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:19 AM
Ignite Modification Date:
2025-12-25 @ 2:19 AM
NCT ID:
NCT06028334
Eligibility Criteria:
Inclusion Criteria:
* Age ≥18
* TBI (open or closed), sustained at least 6 months prior to enrollment, of at least complicated-mild/moderate severity as evidenced by loss or alteration of consciousness ≥ 30 minutes; and/or post-traumatic amnesia (PTA) ≥ 24 hours, not due to intoxication/sedation and documented prospectively from the injury; and/or positive neuroimaging findings consistent with TBI
* Fully weight bearing on lower limbs and able to walk indoors and outdoors without the assistance of another person
* Cognitively able to participate in treatment as judged by ability to travel independently within the community
* Able to communicate adequately in English for participation in the treatment protocols
* Informed consent given by participant
Exclusion Criteria:
* Contraindications to increasing PA as judged by study physician, using an exam based on published screening tools
* Medical or psychiatric instability, including current psychosis or severe uncontrolled substance misuse, as assessed using items from the SCID/MINI/ASSIST, or suicidal ideation with intent or plan, as assessed by the Columbia-Suicide Severity Rating Scale, screening version
* Significant physical or intellectual disability predating the TBI
* Neurodegenerative disorder, e.g., Parkinson's disease
* Insufficiently inactive, i.e., reporting \> 23 weekly moderate/vigorous activity units on the Godin Leisure-Time Exercise Questionnaire
* Planned surgery or other hospitalization during the succeeding 9 months
* Physical or sensory disability (e.g., blindness; severe bimanual incoordination) that prevents use of a smartphone
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06028334
Study Brief:
Protocol Section:
NCT06028334