Program to boost physical activity after traumatic brain injury

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the GetUp&Go program, designed to enhance physical activity in individuals who are at least six months post moderate-to-severe traumatic brain injury (TBI). The program consists of a 10-week remotely delivered intervention that includes one-on-one sessions with a therapist and the use of a mobile health application called RehaBot. Participants are randomized to either receive immediate treatment or be placed on a waitlist, allowing for comparison of physical activity levels and associated health benefits. The study aims to measure changes in physical activity and improvements in mental and physical health outcomes.

Why it matters

Who can join: the full rules

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

Where it's running

• Moss Rehabilitation Research Institute
  Elkins Park, Pennsylvania, United States Recruiting

Study contacts

• Principal investigator: Amanda Rabinowitz, PhD — Albert Einstein Healthcare Network
• Study coordinator: Amanda Rabinowitz, PhD
• Email: amanda.rabinowitz@jefferson.edu
• Phone: 215 663-6526

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.