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Behavioural Intervention

GetUp&Go Program for Traumatic Brain Injury

N/A
Recruiting
Led By Amanda Rabinowitz, PhD
Research Sponsored by Albert Einstein Healthcare Network
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
TBI (open or closed), sustained at least 6 months prior to enrollment, of at least complicated-mild/moderate severity as evidenced by specific criteria
Age ≥18
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 weeks after completing getup&go intervention
Awards & highlights

Study Summary

This trial will test a 10-week program (GetUp&Go) to see if it can help people with moderate-to-severe traumatic brain injury increase physical activity and improve mental/physical health.

Who is the study for?
This trial is for adults over 18 who had a moderate-to-severe traumatic brain injury at least 6 months ago, can walk without help, and are able to use a smartphone. They should be mostly inactive but physically able to do more exercise as judged by the study's doctor.Check my eligibility
What is being tested?
The GetUp&Go program aims to boost physical activity in people with past traumatic brain injuries using therapy sessions and an app called RehaBot. The study checks if this program helps participants become more active and improve their overall health compared to those who wait for treatment.See study design
What are the potential side effects?
Since GetUp&Go involves physical activity enhancement through therapy and an app, side effects may include typical exercise-related issues like muscle soreness or fatigue. However, specific side effects will depend on individual health conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I had a traumatic brain injury at least 6 months ago, of moderate severity.
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I am 18 years old or older.
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I can walk by myself both indoors and outdoors.
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I can communicate well in English for treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 weeks after completing getup&go intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 weeks after completing getup&go intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Average activity counts/minute
Secondary outcome measures
Average daily step count
Emotional function
Fatigue
+6 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Immediate TreatmentExperimental Treatment1 Intervention
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.
Group II: WaitlistPlacebo Group1 Intervention
A 10-week waitlist with baseline and outcome assessment, followed by receipt of the full GetUp&Go program.

Find a Location

Who is running the clinical trial?

Albert Einstein Healthcare NetworkLead Sponsor
64 Previous Clinical Trials
868,642 Total Patients Enrolled
National Institute on Disability, Independent Living, and Rehabilitation ResearchFED
71 Previous Clinical Trials
9,059 Total Patients Enrolled
Amanda Rabinowitz, PhDPrincipal InvestigatorAlbert Einstein Healthcare Network
1 Previous Clinical Trials
119 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this experiment seeking any additional participants?

"As per the information on clinicaltrials.gov, there is presently no requirement for new participants in this medical trial which was initially posted on October 18th 2023 and most recently updated September 7th 2023. Nevertheless, 321 other studies are actively recruiting patients at present."

Answered by AI
~47 spots leftby Apr 2027