Recruiting

GetUp&Go

Sponsor:

Albert Einstein Healthcare Network

Code:

NCT06028334

Conditions

Traumatic Brain Injury

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

GetUp&Go

GetUp&Go with 10-Week Delay

Study Details

Brief summary:

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

Traumatic Brain Injury

Study ID

NCT06028334

Start date

Dec 19, 2023

Status verified date

Feb, 2025

Completion date

Aug 31, 2027

Anticipated

Primary completion date

Apr 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

70 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Immediate Treatment

The 10-week GetUp\&Go intervention will be delivered entirely remotely, with 2 weekly sessions with a therapist delivered over videoconference (Zoom for Healthcare) followed by 3 sessions in weeks 3, 5, and 8, over Zoom or phone according to participant preference.

The overall goal of the intervention is to develop and support a personalized plan to increase physical activity and decrease sedentary behavior, in concert with the unique capabilities, opportunities, and motivational factors of each participant. In session 2 and thereafter, RehaBot will be supplied to participants to deliver therapeutic ingredients to supplement those provided by the therapist.

placebo comparator: Waitlist

A 10-week waitlist with baseline and outcome assessment, followed by receipt of the full GetUp\&Go program.

Interventions

GetUp&Go

A behavioral treatment combining personalized activity planning and a mobile health application for supporting adherence to activity plans.

GetUp&Go with 10-Week Delay

No assigned treatment during the waitlist phase. Participants in the WL group will be offered the GetUp\&Go intervention, which combines personalized activity planning and a mobile health application, after collection of the primary outcome measure.

Primary outcome measure

  • Average activity counts/minute [ Time Frame: Baseline ]
  • Average activity counts/minute [ Time Frame: 10 weeks after initial randomization ]
  • Average activity counts/minute [ Time Frame: 10 weeks after completing GetUp&Go intervention ]

Central Contacts and Locations

Central contacts

Amanda Rabinowitz, PhD

215 663-6526amanda.rabinowitz@jefferson.edu

Lauren Krasucki, DPT, MPH

lauren.krasucki@jefferson.edu

Locations

Moss Rehabilitation Research Institute

Recruiting

Elkins Park, Pennsylvania, United States, 19027

Principal Investigator:

Amanda Rabinowitz, PhD

More Information

Sponsor

Albert Einstein Healthcare Network

Last update posted

Mar 20, 2025

Last verified

Feb, 2025

Keywords

  • physical activity
  • mobile health

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-08. This information was provided to ClinicalTrials.gov by Albert Einstein Healthcare Network on 2025-03-20. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.