Traumatic Brain InjuryNCT06028334
GetUp&Go: A Randomized Controlled Trial of an Intervention to Enhance Physical Activity After TBI
A study testing GetUp&Go and GetUp&Go with 10-Week Delay in people with Traumatic Brain Injury, run by Albert Einstein Healthcare Network at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- GetUp&Go and GetUp&Go with 10-Week Delay
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Dec 2023to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Lauren Krasucki, DPT, MPH contact
United States1 site, 1 recruiting
- Recruiting
Moss Rehabilitation Research Institute
Elkins Park, Pennsylvania, 19027
Amanda Rabinowitz, PhD
About this study
Official title: GetUp&Go: A Randomized Controlled Trial of a Theory-Based Intervention to Enhance Physical Activity in Chronic, Moderate-Severe Traumatic Brain Injury
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?
Read the detailed description
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.
- Conditions
- Traumatic Brain Injury
- Being tested
- GetUp&Go, GetUp&Go with 10-Week Delay
- Keywords
- physical activity, mobile health
- Medical subject headings
- Brain Injuries, Traumatic, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GetUp&GoBehavioural
A behavioral treatment combining personalized activity planning and a mobile health application for supporting adherence to activity plans.
GetUp&Go with 10-Week DelayBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Immediate Treatment | Experimental | 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. Receives: Behavioral: GetUp&Go |
| Waitlist | Placebo comparator | A 10-week waitlist with baseline and outcome assessment, followed by receipt of the full GetUp\&Go program. Receives: Behavioral: GetUp&Go with 10-Week Delay |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 10 weeks after completing GetUp&Go intervention
Secondary outcomes (27)
Percent (%) time sedentary
Actigraphy derived percent time sedentary from wrist-worn Actigraph GT3XP averaged over 4 consecutive-wear days over a 7-day period
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: Baseline
Self-reported PA
Physical Activity Scale for Individuals with Physical Disabilities (Scale: 0-100, where higher scores indicate a greater level of activity)
Measured: 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)
Measured: 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)
Measured: Baseline
Emotional function
Brief Symptom Inventory-18 (Scale: 0-72, where higher scores indicate the presence of more psychiatric symptoms)
Measured: 10 weeks after initial randomization
Emotional function
Brief Symptom Inventory-18 (Scale: 0-72, where higher scores indicate the presence of more psychiatric symptoms)
Measured: 10 weeks after completing GetUp&Go intervention
Fatigue
Fatigue Severity Scale Short Form (Scale: 9-63, where higher scores indicate greater fatigue)
Measured: Baseline
Fatigue
Fatigue Severity Scale Short Form (Scale: 9-63, where higher scores indicate greater fatigue)
Measured: 10 weeks after initial randomization
Fatigue
Fatigue Severity Scale Short Form (Scale: 9-63, where higher scores indicate greater fatigue)
Measured: 10 weeks after completing GetUp&Go intervention
Sleep Quality
Pittsburgh Sleep Quality Index (Scale: 0-21, where higher scores indicate poorer sleep quality)
Measured: Baseline
Sleep Quality
Pittsburgh Sleep Quality Index (Scale: 0-21, where higher scores indicate poorer sleep quality)
Measured: 10 weeks after initial randomization
Sleep Quality
Pittsburgh Sleep Quality Index (Scale: 0-21, where higher scores indicate poorer sleep quality)
Measured: 10 weeks after completing GetUp&Go intervention
Subjective pain
Brief Pain Interference Scale (Scale: 6-30, where higher scores indicate greater pain interference)
Measured: Baseline
Subjective pain
Brief Pain Interference Scale (Scale: 6-30, where higher scores indicate greater pain interference)
Measured: 10 weeks after initial randomization
Subjective pain
Brief Pain Interference Scale (Scale: 6-30, where higher scores indicate greater pain interference)
Measured: 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)
Measured: Baseline
Health-related Quality of Life
Quality of Life after Brain Injury Scale (Scale: 0-100, where higher scores indicate better quality of life)
Measured: 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)
Measured: 10 weeks after completing GetUp&Go intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2023
- Study start19 Dec 2023
- Primary completion30 Apr 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a waitlist controlled randomized trial. All participants will receive the GetUp\&Go treatment program. Participants will be randomly assigned with a 50% chance of either receiving immediate treatment (IT) with the 10-week program, or going on a 10-week waitlist, after which they will start the GetUp\&Go program.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Albert Einstein Healthcare Network
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Disability, Independent Living, and Rehabilitation Research
- Responsible party
- Principal investigator, Amanda Rabinowitz, Albert Einstein Healthcare Network
- Investigators
- Amanda Rabinowitz, PhD, Principal investigator, Albert Einstein Healthcare Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06028334
- Sponsor's protocol ID
- iRISID-2023-1533
- Status last verified
- Feb 2025
- First submitted
- 2 Mar 2023
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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).
Publications
Hart T, Vaccaro M, Krasucki L, Chervoneva I, Rabinowitz A. Increasing physical activity in moderate-severe traumatic brain injury: protocol for a two-stage randomized controlled trial of a remote, mHealth-enhanced intervention. Front Rehabil Sci. 2026 Feb 2;7:1656326. doi: 10.3389/fresc.2026.1656326. eCollection 2026.
PubMed 41705067
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GetUp&Go: A Randomized Controlled Trial of a Theory-Based Intervention to Enhance Physical Activity in Chronic, Moderate-Severe Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT06028334
- Acronym / sponsor ID
- iRISID-2023-1533
- Conditions
- Traumatic Brain Injury
- Keywords
- physical activity, mobile health
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Albert Einstein Healthcare NetworkUniversity, hospital or other
- Collaborators
- National Institute on Disability, Independent Living, and Rehabilitation Research
- Study start
- 19 Dec 2023 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 8 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is a waitlist controlled randomized trial. All participants will receive the GetUp\&Go treatment program. Participants will be randomly assigned with a 50% chance of either receiving immediate treatment (IT) with the 10-week program, or going on a 10-week waitlist, after which they will start the GetUp\&Go program.
| Arm | Type | Receives |
|---|---|---|
| Immediate Treatment | Experimental | Behavioral: GetUp&GoThe 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. |
| Waitlist | Placebo comparator | Behavioral: GetUp&Go with 10-Week DelayA 10-week waitlist with baseline and outcome assessment, followed by receipt of the full GetUp\&Go program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GetUp&GoA behavioral treatment combining personalized activity planning and a mobile health application for supporting adherence to activity plans. | Behavioural | Immediate Treatment |
| GetUp&Go with 10-Week DelayNo 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. | Behavioural | Waitlist |
Primary outcome
Average activity counts/minute
Time frame: Baseline
Actigraphy derived average activity counts/minute from wrist-worn Actigraph GT3XP averaged over 4 consecutive-wear days over a 7-day period
Average activity counts/minute
Time frame: 10 weeks after initial randomization
Actigraphy derived average activity counts/minute from wrist-worn Actigraph GT3XP averaged over 4 consecutive-wear days over a 7-day period
Average activity counts/minute
Time frame: 10 weeks after completing GetUp&Go intervention
Actigraphy derived average activity counts/minute from wrist-worn Actigraph GT3XP averaged over 4 consecutive-wear days over a 7-day period
27 secondary outcomes
Percent (%) time sedentary
Time frame: Baseline
Percent (%) time sedentary
Time frame: 10 weeks after initial randomization
Percent (%) time sedentary
Time frame: 10 weeks after completing GetUp&Go intervention
Percent (%) time engaged in moderate-vigorous physical activity (MVPA)
Time frame: Baseline
Percent (%) time engaged in moderate-vigorous physical activity (MVPA)
Time frame: 10 weeks after initial randomization
Percent (%) time engaged in moderate-vigorous physical activity (MVPA)
Time frame: 10 weeks after completing GetUp&Go intervention
Average daily step count
Time frame: Baseline
Average daily step count
Time frame: 10 weeks after initial randomization
Average daily step count
Time frame: 10 weeks after completing GetUp&Go intervention
Self-reported PA
Time frame: Baseline
Self-reported PA
Time frame: 10 weeks after initial randomization
Self-reported PA
Time frame: 10 weeks after completing GetUp&Go intervention
Emotional function
Time frame: Baseline
Emotional function
Time frame: 10 weeks after initial randomization
Emotional function
Time frame: 10 weeks after completing GetUp&Go intervention
Fatigue
Time frame: Baseline
Fatigue
Time frame: 10 weeks after initial randomization
Fatigue
Time frame: 10 weeks after completing GetUp&Go intervention
Sleep Quality
Time frame: Baseline
Sleep Quality
Time frame: 10 weeks after initial randomization
Sleep Quality
Time frame: 10 weeks after completing GetUp&Go intervention
Subjective pain
Time frame: Baseline
Subjective pain
Time frame: 10 weeks after initial randomization
Subjective pain
Time frame: 10 weeks after completing GetUp&Go intervention
Health-related Quality of Life
Time frame: Baseline
Health-related Quality of Life
Time frame: 10 weeks after initial randomization
Health-related Quality of Life
Time frame: 10 weeks after completing GetUp&Go intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2025.
- Derived from this study: PubMed 41705067Hart T, Vaccaro M, Krasucki L, Chervoneva I, Rabinowitz A. Increasing physical activity in moderate-severe traumatic brain injury: protocol for a two-stage randomized controlled trial of a remote, mHealth-enhanced intervention. Front Rehabil Sci. 2026 Feb 2;7:1656326. doi: 10.3389/fresc.2026.1656326. eCollection 2026.
- Individual participant dataSharing planned: 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).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lauren Krasucki, DPT, MPH contact
Amanda Rabinowitz, PhD principal investigator
Albert Einstein Healthcare Network
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GetUp&Go and GetUp&Go with 10-Week Delay in people with Traumatic Brain Injury, run by Albert Einstein Healthcare Network at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amanda Rabinowitz, PhD (215 663-6526, amanda.rabinowitz@jefferson.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average activity counts/minute (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06028334, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2025.