Walking and Balance Recovery Program for Traumatic Brain Injury

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

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

Trial Summary

What is the purpose of this trial?

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 balance in relation to walking speed, strength, endurance, and balance after traumatic brain injury (TBI). The aim and primary hypothesis of this research project is: Aim) Test and implement a new personalized intervention strategy, in addition to usual and customary care at an inpatient rehabilitation clinic, to improve patient outcomes with secondary conditions associated with impaired balance and walking that typically occur post brain injury. After validation of the locomotor Battery of tests, we will implement a personalized training strategy for individuals based on their battery profile. Hypothesis) Individuals training with this individualized protocol will demonstrate improved walking and balance outcomes and those with lesser pre-intervention impairment will improve at a greater rate than those with greater pre-intervention impairment.

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 data supports the effectiveness of the Walking and Balance Recovery Program for Traumatic Brain Injury treatment?

Research shows that physical therapy, which includes exercises to improve balance and walking, can help people with traumatic brain injury (TBI) improve their ability to walk and maintain balance. For example, a study found that after a series of therapy sessions, participants with TBI showed better balance and walking ability, as measured by specific tests. ^{1 2 3 4 5}

Is the Walking and Balance Recovery Program for Traumatic Brain Injury safe for humans?

Research on similar physical therapy programs for people with traumatic brain injury (TBI) shows that these programs are generally safe. Participants in studies experienced improvements in balance and coordination without reported safety issues. ^{1 3 4 6 7}

How is the Walking and Balance Recovery Program for Traumatic Brain Injury different from other treatments?

The Walking and Balance Recovery Program is unique because it offers a personalized approach to improve walking and balance specifically for individuals with traumatic brain injury (TBI), focusing on task-specific training and functional recovery. Unlike conventional therapies, it may incorporate elements like virtual reality to enhance balance and mobility, providing immersive feedback to aid rehabilitation. ^{1 3 4 5 8}

Research Team

Eligibility Criteria

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 am 18 years old or older.

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.

Trial Timeline

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)

Treatment Details

Interventions

• Post-Brain Injury Walking and Balance Recovery Program (Behavioural Intervention)

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.

Participant Groups

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+

Dr. Vicente Resto

The University of Texas Medical Branch, Galveston

Chief Medical Officer since 2024

MD from Harvard Medical School

Dr. Jochen Reiser

The University of Texas Medical Branch, Galveston

Chief Executive Officer since 2023

MD, PhD from Ruprecht Karls University of Heidelberg, Germany

The Moody Foundation

Collaborator

Trials

5

Recruited

210+

Findings from Research

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]

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 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]

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]

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]

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]

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]

References

1. 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]

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

Effectiveness of physical therapy for improving gait and balance in individuals with traumatic brain injury: a systematic review. [2021]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Effects of physical therapy interventions on balance ability in people with traumatic brain injury: A systematic review. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Physical therapy for correcting postural and coordination deficits in patients with mild-to-moderate traumatic brain injury. [2014]

5. England pubmed.ncbi.nlm.nih.gov

Abnormal muscle activation patterns are associated with chronic gait deficits following traumatic brain injury. [2023]

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

Relating Self-Reported Balance Problems to Sensory Organization and Dual-Tasking in Chronic Traumatic Brain Injury. [2023]

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

Characterization of Balance Control After Moderate to Severe Traumatic Brain Injury: A Longitudinal Recovery Study. [2019]

8. Scotland pubmed.ncbi.nlm.nih.gov

Virtual reality for balance and mobility rehabilitation following traumatic brain injury: A systematic review of randomized controlled trials. [2022]