Physical Therapy for Traumatic Brain Injury

(B-HIST Trial)

Overseen By Kaitlin Hays, DPT

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Craig Hospital

Disqualifiers: Uncontrolled disorders, Orthopedic, Neurological, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

111 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if different types of physical therapy can improve mobility, balance, and cognitive skills in individuals who have experienced a traumatic brain injury (TBI). It compares three approaches: regular walking and balance exercises, High Intensity Step Training (HIST), and intense step training combined with virtual reality. Suitable candidates have had a TBI within the last 6 months, completed initial rehabilitation, and can walk ten feet with some assistance. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, providing participants an opportunity to contribute to significant findings.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies have shown that high-intensity step training benefits people recovering from brain injuries. Participants in these studies improved their balance and walking distance, indicating the training is well-tolerated. Safety measures ensured participants remained safe during exercises.

Adding virtual reality to this high-intensity training also appears promising. Research shows that people with brain injuries responded well to virtual reality, finding it engaging and easy to use, which bodes well for safety and comfort.

Overall, both high-intensity step training and its virtual reality version seem safe for people with brain injuries, based on past research. Participants generally handle these treatments well, and no major safety issues have been reported. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about this trial because it explores innovative approaches to improve recovery for traumatic brain injury (TBI) patients. High Intensity Step Training (HIST) stands out by emphasizing high cardiovascular intensity and more steps per session, potentially enhancing physical endurance and neuromuscular coordination more effectively than traditional methods. Furthermore, the combination of HIST with Virtual Reality (HISTVR) is particularly intriguing, as it aims to stimulate brain activity and muscle engagement simultaneously, which could lead to more significant improvements in motor function and cognitive recovery. These approaches offer a fresh perspective compared to conventional gait and balance training, which typically focuses on steady progression through varied conditions and strength exercises.

What evidence suggests that this trial's treatments could be effective for improving mobility and balance after traumatic brain injury?

This trial will compare different physical therapy approaches for traumatic brain injury recovery. Research has shown that High Intensity Step Training (HIST), one of the treatments participants may receive, can greatly improve walking balance and movement in people recovering from traumatic brain injuries (TBI). Studies have found that patients doing HIST experience greater improvements in fitness and thinking skills compared to traditional therapies. Another treatment option in this trial is High Intensity Step Training with Virtual Reality (HISTVR). Research suggests that using VR makes the therapy more engaging and may further enhance thinking skills. Combining high-intensity training with VR aims to increase brain activity and better activate muscles, potentially leading to improved outcomes. Overall, both methods appear promising in aiding recovery by enhancing movement, balance, and thinking skills. ^{1 6 7 8 9}

Who Is on the Research Team?

Candy Tefertiller, DPT, PhD

Principal Investigator

Craig Hospital

Are You a Good Fit for This Trial?

This trial is for adults who've had a traumatic brain injury (TBI) and are experiencing slower walking speeds. They should be within six months post-injury, weigh under 298 pounds, be shorter than 6'2", able to walk ten feet with minimal assistance, and have completed initial inpatient rehab for TBI. Those with uncontrolled health issues or participating in other trials can't join.

Inclusion Criteria

Weight less than 298 pounds and height less than 6'2" (based on treadmill contraindications)

Ability to follow directions/standardized instructions

O-Log score of at least 20

Exclusion Criteria

I have seizures that my current medication cannot control.

Any reason that, in the opinion of the study investigators or medical team, would interfere with completing the study protocol such as behavioral concerns

I do not have any unmanaged heart, lung, metabolic, or infection issues.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo one of three therapeutic approaches: Conventional Gait and Balance Training, High Intensity Step Training, or High Intensity Step Training with Virtual Reality to improve mobility and balance after TBI

6 weeks

Multiple sessions per week

Follow-up

Participants are monitored for cognitive benefits, walking endurance, balance, and participant enjoyment after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• High Intensity Step Training

Trial Overview

The study tests three methods to improve mobility after TBI: standard gait and balance training; high intensity step training (HIST); and HIST combined with virtual reality. It aims to see if these treatments also enhance cognitive functions alongside physical abilities like balance.

How Is the Trial Designed?

Group I: High Intensity Step Training with Virtual Reality (HISTVR) Experimental Treatment 1 Intervention

The third arm combines virtual reality with HIST, designed to increase cortical excitability while concurrently activating the neuromuscular system.

Group II: High Intensity Step Training (HIST) Experimental Treatment 1 Intervention

High Intensity Step Training (HIST) focuses on the repetition of stepping at higher cardiovascular intensities and yielding a greater number of steps per training session.

Group III: Conventional Gait and Balance Training (CGBT) Active Control 1 Intervention

The current approach for walking retraining, Conventional Gait and Balance Training (CGBT) focuses on walking training in a variety of conditions, obstacle management training, functional independence training, strength training, and standing dynamic balance training.

Who Is Running the Clinical Trial?

Craig Hospital

Lead Sponsor

Trials

45

Recruited

8,400+

Published Research Related to This Trial

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]

High-level mobility (HLM) training appears to be generally safe in the early sub-acute phase following moderate-to-extremely severe traumatic brain injury (TBI), but the lack of comprehensive reporting on adverse events and symptoms makes it difficult to establish a clear safe timeframe for its initiation.

Only six adverse events were reported across 19 studies, with one instance of a concussion-like symptom, indicating that while HLM may not provoke significant issues, more thorough monitoring and research are needed to ensure patient safety during recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The timeframe for safe resumption of high-level mobility following traumatic brain injury is currently unknown: a systematic review. Gallow, S., Hilet, L., Sutherland, E., et al.[2022]

Rhythmic auditory stimulation (RAS) gait training is a safe and feasible intervention for community-dwelling adults with traumatic brain injury (TBI), as evidenced by two participants completing all nine sessions without any adverse events.

The training showed potential benefits, with one participant improving walking speed and reducing gait variability, while the other experienced less fatigue during walking tests, indicating that RAS may help address different gait impairments in TBI patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of a rhythmic auditory stimulation gait training program in community-dwelling adults after TBI: A case report. Sheridan, C., Thaut, C., Brooks, D., et al.[2021]

A single session of high-intensity interval training (HIT) on a treadmill was found to be feasible for stroke survivors, with participants able to walk at speeds significantly faster than their usual overground walking speed, indicating potential for improved rehabilitation outcomes.

No adverse events occurred during the training, and participants reached heart rates in the vigorous exercise range, suggesting that this HIT approach is safe and could enhance cardiovascular fitness in post-stroke rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of single session high-intensity interval training utilizing speed and active recovery to push beyond standard practice post-stroke. Aaron, SE., Gregory, CM.[2022]

A case study of a 36-year-old soldier with traumatic brain injury (TBI) showed that body weight-supported treadmill training (BWSTT) combined with goal-directed therapy improved his gait quality, speed, and distance ambulated.

The results suggest that BWSTT may be an effective intervention for improving mobility in TBI patients, but more research is needed to confirm its efficacy and suitability for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gait rehabilitation with body weight-supported treadmill training for a blast injury survivor with traumatic brain injury. Scherer, M.[2014]

A 4-week home-based circuit training (HBCT) program focusing on strength and balance led to significant improvements in gait speed (0.22 m/s increase) and functional performance in a 17-year-old female with severe traumatic brain injury (TBI).

The participant also showed enhanced self-perception of occupational performance, indicating that HBCT can positively impact both physical abilities and psychological well-being in adolescents recovering from TBI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home-based circuit training program for an adolescent female with severe traumatic brain injury: A case report. Tiwari, D., Daly, C., Alsalaheen, B.[2018]

Exercise interventions can significantly improve outcomes in individuals with traumatic brain injury (TBI) by reducing inflammation and promoting neuroplasticity, which are crucial for recovery.

Tailoring physical exercise programs to the specific type and severity of TBI can enhance their effectiveness, making exercise a valuable non-pharmacologic treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical exercise ameliorates deficits induced by traumatic brain injury. Archer, T., Svensson, K., Alricsson, M.[2012]

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]

Aerobic exercise significantly improves persistent symptoms in individuals with mild traumatic brain injury (mTBI), as shown by a meta-analysis of 3 studies involving 11 total studies, with a notable effect size of -0.39 compared to usual care.

In contrast, the evidence for vestibular exercise is limited and mixed, indicating that while aerobic exercise is beneficial, more research is needed to understand the effects of vestibular interventions on mTBI symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical exercise for people with mild traumatic brain injury: A systematic review of randomized controlled trials. Vuu, S., Barr, CJ., Killington, M., et al.[2022]

Traumatic brain injury significantly affects physical, cognitive, and psychosocial functioning, highlighting the critical role of physical therapy in early rehabilitation.

Various assessment scales, such as the Functional Independence Measure and Glasgow Coma Scale, are essential for evaluating the effectiveness of physical therapy and understanding the complications that can hinder recovery, such as spasticity and depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Physical therapy for persons with traumatic brain injury]. Lendraitienė, E., Kriščiūnas, A.[2018]

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38204184/

Comparative Efficacy of High-Intensity Training Versus ...

The purpose of this blinded-assessor randomized trial was to evaluate the effects of HIT focused on stepping practice versus conventional training on walking ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7034641/

Implementation of High-intensity Stepping Training during ...

Provision of high-intensity stepping training applied during inpatient rehabilitation resulted in significantly greater walking balance outcomes.

3.

liebertpub.com

liebertpub.com/doi/10.1089/neu.2023.0494

Comparative Efficacy of High-Intensity Training Versus ...

In patients with moderate to severe TBI, however, evidence of gains in mobility and cognition with aerobic locomotor activities is scarce.

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04503473

Locomotor Recovery Following Traumatic Brain Injury

In this RCT, patients > 6 post-TBI will be allocated ≤ 15 sessions over approximately 4-5 weeks of high-intensity stepping training or conventional therapy.

5.

journals.sagepub.com

journals.sagepub.com/doi/abs/10.1089/neu.2023.0494

Comparative Efficacy of High-Intensity Training Versus ...

Greater gains were also observed in estimates of aerobic capacity and efficiency after HIT, with additional improvements in selected cognitive assessments. The ...

6.

journals.sagepub.com

journals.sagepub.com/doi/full/10.1089/neu.2023.0494

Comparative Efficacy of High-Intensity Training Versus ...

Greater increases in 6-min walk test and peak treadmill speed during graded exercise testing were observed after HIT versus conventional training, with moderate ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11773168/

Preliminary Investigation of the Impact of High-Intensity ...

This study suggests that HIGT may support functional recovery, and future work will involve increasing sample size. Keywords: aerobic exercise, ...

8.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06343415

Robot-assisted Training After Acquired Brain Injury and ...

The participant will step as intensively as possible within prespecified safety limits. Intensity is considered the most important factor for the feasibility ...

9.

withpower.com

withpower.com/trial/phase-2-brain-injuries-1-2023-ae99f

Physical Therapy for Traumatic Brain Injury (B-HIST Trial)

The B-HIST medical study, being run by Craig Hospital, is evaluating whether High Intensity Step Training will have tolerable side effects & efficacy for ...