GetUp&Go Program for Traumatic Brain Injury

Overseen By Lauren Krasucki, DPT, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Albert Einstein Healthcare Network

Disqualifiers: Psychosis, Substance misuse, Neurodegenerative, others

Compensation: Varies

Number of Visits: 2

70 Participants Needed

Trial Summary

What is the purpose of this trial?

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?

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the GetUp&Go Program for Traumatic Brain Injury treatment?

Research shows that intensive rehabilitation, including sit-to-stand training and rhythmic exercises with auditory cues, can improve motor performance and functional outcomes in patients with traumatic brain injury. These findings suggest that similar approaches in the GetUp&Go Program may be effective in enhancing recovery. ^{1 2 3 4 5}

Is the GetUp&Go Program safe for humans?

The available studies on similar exercise programs for traumatic brain injury (TBI) and concussions report no adverse events, suggesting that these types of exercise interventions are generally safe for humans. ^{3 6 7 8 9}

How is the GetUp&Go treatment for traumatic brain injury different from other treatments?

The GetUp&Go Program is unique because it likely incorporates a multidisciplinary approach and possibly uses robotic locomotor training, which can enhance training capacity and reduce the physical demands on staff compared to traditional gait training methods. ^{3 4 5 10 11}

Research Team

Amanda Rabinowitz, PhD

Principal Investigator

Albert Einstein Healthcare Network

Eligibility Criteria

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.

Inclusion Criteria

Informed consent given by participant

I had a traumatic brain injury at least 6 months ago, of moderate severity.

I am 18 years old or older.

Exclusion Criteria

You are currently not in stable mental or physical health, including severe substance misuse or psychosis.

I have a neurodegenerative condition like Parkinson's disease.

My doctor says it's unsafe for me to increase my physical activity.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Acquisition (A phase)

Participants receive the 10-week GetUp&Go intervention, including one-on-one sessions with a therapist and use of the RehaBot mobile health application.

10 weeks

2 weekly sessions (videoconference), 3 additional sessions in weeks 3, 5, and 8

Follow-Through (FT phase)

Participants are randomized to either continue using RehaBot or not, to support maintenance of physical activity gains.

10 weeks

No therapist contact, RehaBot use varies by group

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• GetUp&Go

Trial Overview 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.

Participant Groups

Group I: Immediate Treatment Experimental Treatment 1 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: Waitlist Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Albert Einstein Healthcare Network

Lead Sponsor

Trials

65

Recruited

869,000+

National Institute on Disability, Independent Living, and Rehabilitation Research

Collaborator

Trials

83

Recruited

10,500+

Findings from Research

Intensive sit-to-stand training significantly improved motor performance in patients with severe traumatic brain injury, with the experimental group showing a 62% increase in repetitions compared to 18% in the control group.

While the training did not lead to significant differences in exercise capacity or efficiency, improvements in peak oxygen consumption were correlated with increased sit-to-stand repetitions, suggesting a link between motor performance and exercise capacity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of the effects of intensive sit-to-stand training after recent traumatic brain injury on sit-to-stand performance. Canning, CG., Shepherd, RB., Carr, JH., et al.[2017]

In a study of 68 patients with moderate-to-severe traumatic brain injury (TBI), those undergoing high-intensity rehabilitation (4 hours/day) showed a faster recovery, achieving higher scores on the Functional Independence Measure (FIM) and Glasgow Outcome Scale (GOS) in the early months compared to those in a lower intensity program (2 hours/day).

While early intensive rehabilitation improved recovery speed, it did not significantly change the final functional outcomes, suggesting that while it helps patients regain independence sooner, it may not affect long-term results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does intensive rehabilitation improve the functional outcome of patients with traumatic brain injury (TBI)? A randomized controlled trial. Zhu, XL., Poon, WS., Chan, CC., et al.[2014]

A 24-year-old female patient, nine years post-traumatic brain injury, showed significant improvements in gait and motor functions after participating in Rhythmic Exercises with Auditory Cues (REAC), which involved synchronized movements with a metronome.

The patient experienced reduced spasticity, regained some voluntary movements and sensation in her right arm and leg, and improved cognitive function, as indicated by an increase in IQ scores from 78 to 94.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rhythmic exercises in rehabilitation of TBI patients: a case report. Goldshtrom, Y., Knorr, G., Goldshtrom, I.[2013]

A 26-year-old man with severe chronic traumatic brain injury showed significant improvement in walking ability after a 62-week task-specific training program that included 79 treatments, utilizing methods like locomotor treadmill training and electrical stimulation.

By the end of the therapy, he was able to walk independently for about 1 km with a gait trainer and 100 m in the community with assistance, demonstrating that targeted interventions can lead to unexpected functional recovery even years after injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Clinical Framework for Functional Recovery in a Person With Chronic Traumatic Brain Injury: A Case Study. McCain, K., Shearin, S.[2018]

Two patients with severe traumatic brain injury (TBI) showed significant improvements in high-level mobility over a 6-month intervention, demonstrating that targeted rehabilitation can enhance mobility even years after injury.

Both patients were able to run by the end of the intervention, with one patient improving gait symmetry and the other enhancing postural control, indicating that tailored rehabilitation strategies can effectively address different mobility challenges after TBI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a conceptual framework for retraining high-level mobility following traumatic brain injury: two case reports. Williams, GP., Schache, AG.[2019]

The Montreal Virtual Exertion (MOVE) protocol is a safe and feasible graded exertion test for both healthy children and those with subacute concussion, as no adverse events were reported during the study.

Increases in heart rate and perceived exertion were similar between the MOVE protocol and the traditional Buffalo Concussion Treadmill Test, suggesting that MOVE can effectively assess exertion levels without the need for expensive equipment or in-person supervision.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An At-Home, Virtually Administered Graded Exertion Protocol for Use in Concussion Management: Preliminary Evaluation of Safety and Feasibility for Determining Clearance to Return to High-Intensity Exercise in Healthy Youth and Children With Subacute Concussion. Teel, E., Alarie, C., Swaine, B., et al.[2023]

A 3-month community-based aerobic exercise training program showed a trend toward improved cardiorespiratory fitness (CRF) in individuals with traumatic brain injury (TBI), with an 8% increase in VO2peak compared to a 4% decrease in a stretching and toning group, indicating potential efficacy of aerobic exercise for this population.

The study demonstrated that while it is feasible to conduct exercise training in community settings for TBI patients, only 50% of participants adhered to the program, highlighting the need for strategies to improve adherence in future trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A proof-of-concept trial of a community-based aerobic exercise program for individuals with traumatic brain injury. Ding, K., Tarumi, T., Tomoto, T., et al.[2021]

In a small clinical trial with 12 adults with traumatic brain injury (TBI), an 8-week program of rapid-resisted elliptical training significantly improved dynamic balance and motor processing speed, as measured by the High-Level Mobility Assessment Tool (HiMAT) and dual-task performance.

The training not only enhanced physical abilities but also positively impacted sleep quality, which correlated with reductions in depression and improvements in learning, highlighting the interconnectedness of physical and cognitive recovery in TBI patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a rapid-resisted elliptical training program on motor, cognitive and neurobehavioral functioning in adults with chronic traumatic brain injury. Damiano, DL., Zampieri, C., Ge, J., et al.[2023]

A phase 1 trial involving 40 healthy university students showed that an aerobic exercise training program for concussion rehabilitation is feasible, with 60% of participants completing all sessions without any adverse events.

Participants demonstrated good adherence to the training protocol, completing an average of 30 additional minutes of physical activity on training days, suggesting that aerobic exercise could be a beneficial intervention for concussion management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized Controlled Trial Investigating the Feasibility and Adherence to an Aerobic Training Program in Healthy Individuals. Teel, EF., Marshall, SW., Appelbaum, LG., et al.[2019]

The rehabilitation program for military service members with moderate to severe traumatic brain injury (TBI) was effective, with 96% of participants returning to work and 66% returning to active duty after one year.

This eight-week program combined various therapies, including group and individual sessions focused on cognitive and work skills, demonstrating a comprehensive approach to TBI rehabilitation in a military setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A multidisciplinary TBI inpatient rehabilitation programme for active duty service members as part of a randomized clinical trial. Braverman, SE., Spector, J., Warden, DL., et al.[2019]

In a study involving 22 individuals with chronic traumatic brain injury, all three locomotor training methods (G-EO, Lokomat, and PBWSTT) significantly improved self-selected walking velocity (SSV) and maximal velocity (MV) after 18 sessions, indicating their efficacy in enhancing gait performance.

The Lokomat system required less staff assistance compared to the G-EO method, suggesting it may be a more efficient option for rehabilitation settings, although all methods did not show significant differences in gait symmetry improvements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Comparison of Locomotor Therapy Interventions: Partial-Body Weight-Supported Treadmill, Lokomat, and G-EO Training in People With Traumatic Brain Injury. Esquenazi, A., Lee, S., Wikoff, A., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of the effects of intensive sit-to-stand training after recent traumatic brain injury on sit-to-stand performance. [2017]

2. England pubmed.ncbi.nlm.nih.gov

Does intensive rehabilitation improve the functional outcome of patients with traumatic brain injury (TBI)? A randomized controlled trial. [2014]

3. United States pubmed.ncbi.nlm.nih.gov

Rhythmic exercises in rehabilitation of TBI patients: a case report. [2013]

4. United States pubmed.ncbi.nlm.nih.gov

A Clinical Framework for Functional Recovery in a Person With Chronic Traumatic Brain Injury: A Case Study. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Evaluation of a conceptual framework for retraining high-level mobility following traumatic brain injury: two case reports. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

An At-Home, Virtually Administered Graded Exertion Protocol for Use in Concussion Management: Preliminary Evaluation of Safety and Feasibility for Determining Clearance to Return to High-Intensity Exercise in Healthy Youth and Children With Subacute Concussion. [2023]

7. England pubmed.ncbi.nlm.nih.gov

A proof-of-concept trial of a community-based aerobic exercise program for individuals with traumatic brain injury. [2021]

8. Germany pubmed.ncbi.nlm.nih.gov

Effects of a rapid-resisted elliptical training program on motor, cognitive and neurobehavioral functioning in adults with chronic traumatic brain injury. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

A Randomized Controlled Trial Investigating the Feasibility and Adherence to an Aerobic Training Program in Healthy Individuals. [2019]

10. England pubmed.ncbi.nlm.nih.gov

A multidisciplinary TBI inpatient rehabilitation programme for active duty service members as part of a randomized clinical trial. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

A Comparison of Locomotor Therapy Interventions: Partial-Body Weight-Supported Treadmill, Lokomat, and G-EO Training in People With Traumatic Brain Injury. [2022]