Walking and Balance Recovery Program for Traumatic Brain Injury

Overseen By Negar Moradian, MD-MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas Medical Branch, Galveston

Must not be taking: Phenol, Botulinum toxin

Disqualifiers: Serious cardiac disease, Cerebellar deficits, others

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

Compensation: Varies

Number of Visits: 15

Duration: 4-8 weeks

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new walking and balance training program for individuals recovering from a traumatic brain injury (TBI). The Post-Brain Injury Walking and Balance Recovery Program aims to enhance walking speed, strength, endurance, and balance through sessions on a robotic treadmill. It is designed for those who can walk, with or without assistance, and are currently receiving care at the Moody Neurorehabilitation Institute. Participants must be medically stable and able to communicate in English or through an interpreter. This trial offers a chance to improve mobility and balance as part of a personalized recovery plan. As an unphased trial, it provides a unique opportunity to contribute to innovative rehabilitation research and potentially enhance the recovery journey.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, it mentions that participants must be medically stable, which might imply that your current medications should be effectively managing any conditions you have.

What prior data suggests that this walking and balance training program is safe for individuals with traumatic brain injury?

Research has shown that aerobic exercise can aid recovery from traumatic brain injuries (TBI). Studies have found that this exercise improves walking, balance, and stamina in individuals with TBI.

One study on high-intensity walking training after TBI focused on increasing participants' walking speed, balance, and stamina. The results suggested that this training can be safe and beneficial. Although the study did not identify major safety issues, individual reactions to exercise can vary.

Generally, exercise programs like these are well-tolerated, but discussing any concerns with a healthcare provider is advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Post-Brain Injury Walking and Balance Recovery Program because it uses a robotic treadmill to enhance gait rehabilitation. Unlike standard treatments that might focus on traditional physical therapy, this program emphasizes endurance, strength, speed, and balance through 12-16 specialized sessions. The innovative use of robotic technology allows for precise adjustments and personalized scaffolding, potentially leading to more effective recovery outcomes for individuals with traumatic brain injury.

What evidence suggests that this walking and balance recovery program is effective for traumatic brain injury?

Studies have shown that training in balance and walking can aid recovery after a traumatic brain injury (TBI). Research indicates that these programs can improve walking speed, strength, endurance, and balance. In this trial, participants will undergo a Gait Rehabilitation program, which includes 12-16 sessions on a robotic treadmill, focusing on gait scaffolds: endurance, strength, speed, and balance. For those with long-term TBI, specific balance training has greatly improved balance scores, with benefits lasting at least 12 weeks after stopping the exercises. This suggests that personalized walking and balance exercises might effectively enhance walking ability and stability. Initial findings also suggest that individuals with less severe initial impairments may experience improvements more quickly. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for adults over 18 who have had a traumatic brain injury and are currently in rehab at the Moody Neurorehabilitation Institute. They should be able to walk (with or without help), speak English or have an interpreter, and be medically stable with controlled blood pressure.

Inclusion Criteria

I have difficulty speaking but have a caregiver to help when needed.

I speak English or have an English-speaking interpreter for the study.

I can walk by myself or with help like a cane or walker.

Exclusion Criteria

I do not have unmanaged breathing or metabolic conditions.

I have had a serious heart condition, like a heart attack.

I have lost a lower limb.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Treatment

Participants undergo 12-16 gait rehabilitation sessions on a robotic treadmill, focusing on endurance, strength, speed, and balance

4-8 weeks

12-16 visits (in-person)

Follow-up

Participants are monitored for improvements in walking and balance using the Berg Balance Scale and 10-Meter Walk Test

1-2 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Post-Brain Injury Walking and Balance Recovery Program

Trial Overview The study tests a new walking and balance training program using the KineAssist robotic treadmill. It aims to improve walking speed, strength, endurance, and balance after brain injury compared to usual care.

How Is the Trial Designed?

Group I: Gait Rehabilitation Experimental Treatment 1 Intervention

12-16 gait rehabilitation sessions on a robotic treadmill, emphasizing gait scaffolds: endurance, strength, speed, and balance. 3-4 sessions of training for each.

Who Is Running the Clinical Trial?

The University of Texas Medical Branch, Galveston

Lead Sponsor

Trials

263

Recruited

55,400+

The Moody Foundation

Collaborator

Trials

5

Recruited

210+

Published Research Related to This Trial

A systematic review of eight studies involving 259 individuals with post-traumatic brain injury (TBI) found that physical therapy interventions had limited evidence in improving balance deficits, with no significant differences observed between various types of interventions, including virtual reality and vestibular rehabilitation therapy.

The methodological quality of the studies varied, and the authors concluded that more randomized controlled trials are needed to better understand the effectiveness of physical therapy for balance impairments in TBI patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of physical therapy interventions on balance ability in people with traumatic brain injury: A systematic review. Alashram, AR., Annino, G., Raju, M., et al.[2020]

In a study of 45 participants with moderate to severe traumatic brain injury (TBI), balance recovery was assessed over 12 months, revealing persistent postural sway issues, particularly in the mediolateral (ML) direction, which did not improve throughout recovery.

The findings suggest that individuals with TBI maintain higher postural sway and reduced interlimb synchrony compared to healthy controls, indicating a potential increased risk for falls due to ongoing balance impairments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characterization of Balance Control After Moderate to Severe Traumatic Brain Injury: A Longitudinal Recovery Study. Perez, OH., Green, RE., Mochizuki, G.[2019]

A review of five randomized controlled trials involving 157 patients with traumatic brain injury (TBI) found that virtual reality (VR) interventions did not show superior effectiveness compared to traditional physiotherapy for improving balance and mobility.

The results suggest that while VR has potential benefits for TBI rehabilitation, combining it with other rehabilitation methods may lead to better outcomes, and further research is needed to determine the most effective VR treatment protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality for balance and mobility rehabilitation following traumatic brain injury: A systematic review of randomized controlled trials. Alashram, AR., Padua, E., Annino, G.[2022]

Individuals with mild to moderate traumatic brain injury (TBI) show abnormal muscle activation patterns in specific lower limb muscles, such as the tibialis anterior and medial gastrocnemius, which may affect their gait and balance.

These abnormal activation patterns are significantly correlated with gait deficits, as measured by the dynamic gait index, indicating that changes in muscle coordination contribute to walking impairments in TBI patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Abnormal muscle activation patterns are associated with chronic gait deficits following traumatic brain injury. Acuña, SA., Tyler, ME., Danilov, YP., et al.[2023]

A conventional exercise program for patients with mild-to-moderate traumatic brain injury (TBI) significantly improved postural stability and gait after 20 therapy sessions over four weeks, as shown by increases in the Berg Balance Scale and Functional Gait Assessment scores.

Participants also experienced a reduction in ataxia, indicating enhanced coordination in both upper and lower extremities, which suggests that this targeted exercise approach may be effective in rehabilitating TBI-related deficits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical therapy for correcting postural and coordination deficits in patients with mild-to-moderate traumatic brain injury. Ustinova, KI., Chernikova, LA., Dull, A., et al.[2014]

A review of 20 studies on non-aerobic exercise interventions for improving balance and gait in individuals with mild-to-moderate traumatic brain injury (TBI) found limited evidence of effectiveness, highlighting the need for better quality research.

The studies reviewed often had small sample sizes and varied methodologies, indicating that future research should focus on standardizing interventions and outcome measures to provide clearer insights into their efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of physical therapy for improving gait and balance in individuals with traumatic brain injury: a systematic review. Bland, DC., Zampieri, C., Damiano, DL.[2021]

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]

In a study of 50 adults with a history of traumatic brain injury (TBI), balance problems were more closely linked to deficits in dual-task gait performance rather than vestibular dysfunction, suggesting that automaticity of gait plays a significant role in chronic balance issues.

Symptomatic individuals reported more balance problems and had poorer cognitive output and slower gait velocity during dual-task assessments, indicating that rehabilitation for chronic TBI patients should focus on dual-task challenges and consider cognitive and emotional factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relating Self-Reported Balance Problems to Sensory Organization and Dual-Tasking in Chronic Traumatic Brain Injury. Joseph, AC., Lippa, SM., Moore, B., et al.[2023]

Citations

1. trial.medpath.com trial.medpath.com/clinical-trial/956c4c5483a9bad2/nct05934773-post-brain-injury-walking-balance-recovery

Post-Brain Injury Walking and Balance Recovery Program The purpose of this study is to test the efficacy of a walking and balance training program designed to safely challenge and improve walking performance and ...

2. smartpatients.com smartpatients.com/trials/NCT05934773

Post-Brain Injury Walking and Balance Recovery Program The purpose of this study is to test the efficacy of a walking and balance training program designed to safely challenge and improve walking performance and ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3319122/

Effectiveness of physical therapy for improving gait and ... We found limited evidence of the positive effects of balance, gait, or the combination of both interventions, in TBI rehabilitation.

4. aging.networkofcare.org aging.networkofcare.org/sanmateo/CommunityResources/ClinicalTrials/Detail/NCT05934773?keyword=%22Treadmill%22

Post-Brain Injury Walking and Balance Recovery Program In this study, we will be evaluating our novel gait training protocol efficacy for improving TBI individuals walking regarding their endurance, balance, and ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0003999314002895

Individuals With Chronic Traumatic Brain Injury Improve ... Both the HFP+PT and LFP+PT groups had significantly improved balance scores, and outcomes were sustained for 12 weeks after discontinuing TLNS treatment.

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

Preliminary Investigation of the Impact of High-Intensity ... This study evaluated the treatment strategy of HIGT post-TBI based on gait speed, endurance, balance, functional mobility, and cognitive ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10771390/

Brain changes: aerobic exercise for traumatic brain injury ... Aerobic exercise is a promising intervention for adolescent and adult TBI survivors, regardless of injury severity.