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โ† Trials
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GetUp&Go: A Randomized Controlled Trial of an Intervention to Enhance Physical Activity After TBI

RecruitingNAAges 18 Years - anyAllAlbert Einstein Healthcare Network
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In plain words

What the trial is, and whether it could suit you

The goal of this clinical trial is to evaluate GetUp\&Go, a program for promoting increased physical activity in individuals at least 6 months post moderate-to-severe traumatic brain injury. GetUp\&Go is a remotely delivered 10-week program that includes one-on-one sessions with a therapist and a mobile health application (RehaBot). The main question is whether participants in the 10-week GetUp\&Go program increase their physical activity, and exhibit associated benefits in mental and physical health, relative to those who are put on a waitlist. * Question 1: Do participants who receive immediate treatment with GetUp\&Go show more increased physical activity, measured by accelerometer activity counts per day, and improve more on secondary outcomes, such as self-reported physical activity, emotional function, fatigue, sleep, pain, and health-related quality of life, compared to their ba

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Age โ‰ฅ18 * 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 โ‰ฅ 30 minutes; and/or post-traumatic amnesia (PTA) โ‰ฅ 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
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What it tests

  • GetUp&Go
  • GetUp&Go with 10-Week Delay
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Where

1 site
Moss Rehabilitation Research Institute
Elkins Park, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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