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New treatment option for Traumatic Brain Injury
Official title GetUp&Go: A Randomized Controlled Trial of an Intervention to Enhance Physical Activity After TBI
ClinicalTrials.gov ID: NCT06028334
What this study is testing
- What it's testing
- 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).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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
You likely can't join if
- 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...
- 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
See the full eligibility 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)...
- 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
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Elkins Park, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Elkins Park, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.