An interventional study of GetUp&Go and GetUp&Go with 10-Week Delay in Traumatic Brain Injury, sponsored by Albert Einstein Healthcare Network. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-20.
Sponsored by Albert Einstein Healthcare Network · Not applicable, Interventional, and Treatment
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.
The investigators will conduct a Randomized Controlled Trial (RCT) of a novel, remotely delivered physical activity (PA) promotion program, called GetUp\&Go-a name selected by focus group participants with moderate-to-severe traumatic brain injury (msTBI). It will be theoretically based, use objective measurement of PA as a primary outcome, and incorporate varied types and amounts of home- and neighborhood-based PA and ways to reduce sedentary behavior, according to participant preferences. Moreover, using a 2-phase design as described below, the investigators will test a method for enhancing longer-term gains in PA using mobile technology, in addition to gains acquired during the first phase of intervention.
Trial design. Participants will undergo baseline testing (T1) and will then be randomized 1:1 to either immediate treatment in GetUp\&Go (IT) or waitlist (WL) for 10 weeks. After testing for the primary outcome (T2), the waitlist group will receive GetUp\&Go for 10 weeks followed by a T2b evaluation for that group. This phase is called the "A phase", for Acquisition.
Following completion of the GetUp\&Go intervention, all participants-regardless of initial group allocation-will be randomized 1:1 to one of two conditions for an additional 10 weeks, the "Follow-Through" (FT) phase. Half of participants will be randomized to the RehaBot condition (RB), which provides continued use of the chatbot to support individualized PA plans, but with no further therapist contact. Participants in the No RehaBot (No RB) condition will not have access to the chatbot. The final evaluation, T3, will occur after the 10-week Follow-Through phase.
1,721 studies on the registry are indexed under Brain Injuries, Traumatic; 447 are open to participants now.
This study's planned enrollment of 70 is above the median of 52 across 1,088 interventional studies indexed under Brain Injuries, Traumatic.
Browse Brain Injuries, Traumatic studies →Albert Einstein Healthcare Network is the lead sponsor of 63 studies on the registry; 6 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 3 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: GetUp&Go
A 10-week waitlist with baseline and outcome assessment, followed by receipt of the full GetUp\&Go program.
Behavioral: GetUp&Go with 10-Week Delay
A behavioral treatment combining personalized activity planning and a mobile health application for supporting adherence to activity plans.
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.
Average activity counts/minute
Actigraphy derived average activity counts/minute from wrist-worn Actigraph GT3XP averaged over 4 consecutive-wear days over a 7-day period
Time frame: Baseline
Average activity counts/minute
Actigraphy derived average activity counts/minute from wrist-worn Actigraph GT3XP averaged over 4 consecutive-wear days over a 7-day period
Time frame: 10 weeks after initial randomization
Average activity counts/minute
Actigraphy derived average activity counts/minute from wrist-worn Actigraph GT3XP averaged over 4 consecutive-wear days over a 7-day period
Time frame: 10 weeks after completing GetUp&Go intervention
Percent (%) time sedentary
Actigraphy derived percent time sedentary from wrist-worn Actigraph GT3XP averaged over 4 consecutive-wear days over a 7-day period
Time frame: Baseline
Percent (%) time sedentary
Actigraphy derived percent time sedentary from wrist-worn Actigraph GT3XP averaged over 4 consecutive-wear days over a 7-day period
Time frame: 10 weeks after initial randomization
Percent (%) time sedentary
Actigraphy derived percent time sedentary from wrist-worn Actigraph GT3XP averaged over 4 consecutive-wear days over a 7-day period
Time frame: 10 weeks after completing GetUp&Go intervention
Percent (%) time engaged in moderate-vigorous physical activity (MVPA)
Actigraphy derived percent time engaged in MVPA from wrist-worn Actigraph GT3XP averaged over 4 consecutive-wear days over a 7-day period
Time frame: Baseline
Percent (%) time engaged in moderate-vigorous physical activity (MVPA)
Actigraphy derived percent time engaged in MVPA from wrist-worn Actigraph GT3XP averaged over 4 consecutive-wear days over a 7-day period
Time frame: 10 weeks after initial randomization
Percent (%) time engaged in moderate-vigorous physical activity (MVPA)
Actigraphy derived percent time engaged in MVPA from wrist-worn Actigraph GT3XP averaged over 4 consecutive-wear days over a 7-day period
Time frame: 10 weeks after completing GetUp&Go intervention
Average daily step count
Actigraphy derived average daily step count from wrist-worn Actigraph GT3XP averaged over 4 consecutive-wear days over a 7-day period
Time frame: Baseline
Average daily step count
Actigraphy derived average daily step count from wrist-worn Actigraph GT3XP averaged over 4 consecutive-wear days over a 7-day period
Time frame: 10 weeks after initial randomization
Average daily step count
Actigraphy derived average daily step count from wrist-worn Actigraph GT3XP averaged over 4 consecutive-wear days over a 7-day period
Time frame: 10 weeks after completing GetUp&Go intervention
Self-reported PA
Physical Activity Scale for Individuals with Physical Disabilities (Scale: 0-100, where higher scores indicate a greater level of activity)
Time frame: Baseline
Self-reported PA
Physical Activity Scale for Individuals with Physical Disabilities (Scale: 0-100, where higher scores indicate a greater level of activity)
Time frame: 10 weeks after initial randomization
Self-reported PA
Physical Activity Scale for Individuals with Physical Disabilities (Scale: 0-100, where higher scores indicate a greater level of activity)
Time frame: 10 weeks after completing GetUp&Go intervention
Emotional function
Brief Symptom Inventory-18 (Scale: 0-72, where higher scores indicate the presence of more psychiatric symptoms)
Time frame: Baseline
Emotional function
Brief Symptom Inventory-18 (Scale: 0-72, where higher scores indicate the presence of more psychiatric symptoms)
Time frame: 10 weeks after initial randomization
Emotional function
Brief Symptom Inventory-18 (Scale: 0-72, where higher scores indicate the presence of more psychiatric symptoms)
Time frame: 10 weeks after completing GetUp&Go intervention
Fatigue
Fatigue Severity Scale Short Form (Scale: 9-63, where higher scores indicate greater fatigue)
Time frame: Baseline
Fatigue
Fatigue Severity Scale Short Form (Scale: 9-63, where higher scores indicate greater fatigue)
Time frame: 10 weeks after initial randomization
Fatigue
Fatigue Severity Scale Short Form (Scale: 9-63, where higher scores indicate greater fatigue)
Time frame: 10 weeks after completing GetUp&Go intervention
Sleep Quality
Pittsburgh Sleep Quality Index (Scale: 0-21, where higher scores indicate poorer sleep quality)
Time frame: Baseline
Sleep Quality
Pittsburgh Sleep Quality Index (Scale: 0-21, where higher scores indicate poorer sleep quality)
Time frame: 10 weeks after initial randomization
Sleep Quality
Pittsburgh Sleep Quality Index (Scale: 0-21, where higher scores indicate poorer sleep quality)
Time frame: 10 weeks after completing GetUp&Go intervention
Subjective pain
Brief Pain Interference Scale (Scale: 6-30, where higher scores indicate greater pain interference)
Time frame: Baseline
Subjective pain
Brief Pain Interference Scale (Scale: 6-30, where higher scores indicate greater pain interference)
Time frame: 10 weeks after initial randomization
Subjective pain
Brief Pain Interference Scale (Scale: 6-30, where higher scores indicate greater pain interference)
Time frame: 10 weeks after completing GetUp&Go intervention
Health-related Quality of Life
Quality of Life after Brain Injury Scale (Scale: 0-100, where higher scores indicate better quality of life)
Time frame: Baseline
Health-related Quality of Life
Quality of Life after Brain Injury Scale (Scale: 0-100, where higher scores indicate better quality of life)
Time frame: 10 weeks after initial randomization
Health-related Quality of Life
Quality of Life after Brain Injury Scale (Scale: 0-100, where higher scores indicate better quality of life)
Time frame: 10 weeks after completing GetUp&Go intervention
Plan to share: Yes — All data collected for this trial will be submitted the Federal Interagency Traumatic Brain Injury Research (FITBIR) informatics system. The data submitted to FITBIR will be fully de-identified and contain the Global Unique Identifier (GUID). The investigators will assign GUIDs to cases using the methodology recommended by FITBIR. If it is not possible to assign a GUID to cases, a Pseudo-GUID will be assigned. All variables will be converted to the TBI Common Data Elements (CDEs), to the extent possible; otherwise variables that do not map to the TBI CDEs will be submitted as Unique Data Elements (UDEs).
Supporting information: Study protocol
Time frame: All data from this trial will be submitted to FITBIR within one year of the completion of the award, per the FITBIR submission schedule for clinical trials.
Access criteria: Projects must be specified for research purposes only (not commercial) with the intention to enhance knowledge for the benefit of human health. Individuals requesting access must have a medical or scientific degree or position relevant for the request. Individuals must be affiliated with a research, industry, or non-profit institution/business/organization. All data access requests must be signed by an individual legally authorized to sign on behalf of the institution/business/organization.
Data sharing details ↗ · fitbir.nih.gov
No publications or documents are linked to this record.
Started Dec 2023 (actual). Primary completion is estimated for Apr 2027, 40 months after the start.
Of 442 non-industry interventional studies with no phase under Brain Injuries, Traumatic, half reached primary completion within 41 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 64. This study's planned 40 months is close to that.
Counting every sponsor, half of 464 studies reached it within 40 months; a quarter within 22 and three quarters within 64.
How these figures are worked out, and which studies are left out of them.
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