Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06028334

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

Led by Albert Einstein Healthcare Network · Updated on 2025-03-20

70

Participants Needed

1

Research Sites

193 weeks

Total Duration

On this page

Sponsors

A

Albert Einstein Healthcare Network

Lead Sponsor

N

National Institute on Disability, Independent Living, and Rehabilitation Research

Collaborating Sponsor

AI-Summary

What this Trial Is About

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 baseline, relative to those who are put on a waitlist? * Question 2: Do participants who have continued access to the mobile health component of the intervention, RehaBot, show better maintenance of physical activity gains compared to those who no longer have access to RehaBot? * Question 3: Are individual participant characteristics associated with participants' response to the treatment program?

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Traumatic brain injury (open or closed) sustained at least 6 months before enrollment, with at least complicated-mild/moderate severity as shown by loss or alteration of consciousness for 30 minutes or more, post-traumatic amnesia for 24 hours or more, or positive neuroimaging findings
  • Fully weight bearing on lower limbs and able to walk indoors and outdoors without assistance
  • Cognitively able to participate and travel independently in the community
  • Able to communicate adequately in English for treatment participation
  • Provided informed consent
Not Eligible

You will not qualify if you...

  • Medical or psychiatric conditions that contraindicate increasing physical activity, as judged by the study physician
  • Medical or psychiatric instability including current psychosis, severe uncontrolled substance misuse, or suicidal ideation with intent or plan
  • Significant physical or intellectual disability present before the traumatic brain injury
  • Neurodegenerative disorders such as Parkinson's disease
  • Reporting more than 23 weekly moderate or vigorous activity units on the Godin Leisure-Time Exercise Questionnaire
  • Planned surgery or hospitalization during the next 9 months
  • Physical or sensory disability preventing use of a smartphone, such as blindness or severe incoordination

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Moss Rehabilitation Research Institute

Elkins Park, Pennsylvania, United States, 19027

Actively Recruiting

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Research Team

A

Amanda Rabinowitz, PhD

CONTACT

L

Lauren Krasucki, DPT, MPH

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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