Balance Training for Traumatic Brain Injury

Overseen By Kiran K Karunakaran, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Kessler Foundation

Must not be taking: Botox

Disqualifiers: Severe cardiac disease, Orthopedic conditions, others

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

Compensation: Varies

Number of Visits: 18

Duration: 16 weeks

45 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a specific balance training program can help individuals with traumatic brain injury (TBI) avoid falls. It includes three groups: those with TBI who receive the training, those with TBI who do not, and healthy individuals who also do not receive training. The training, called Perturbation-based Training with visual cues using Neurocom, employs special equipment to help participants adjust their posture and improve balance. Ideal candidates for the TBI training group have lived with a TBI for at least six months and can stand without support for five minutes. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance balance and reduce fall risk for TBI patients.

Will I have to stop taking my current medications?

The trial does not require you to stop taking your current medications, but you should not make any drastic changes to them for at least 4 weeks. If you are on medication that affects balance, strength, or muscle coordination, you may not be eligible to participate.

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

Research shows that balance training using visual signals and sudden movements is generally safe for people with traumatic brain injuries (TBIs). Studies have found that this type of training is well-received and often improves balance and prevents falls. Participants wear a safety harness, and a helper ensures safety during the exercises. Available studies report no serious side effects, suggesting that this training is safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a unique approach to balance training for individuals with traumatic brain injury (TBI). Unlike traditional rehabilitation methods that may focus more on general physical therapy, this trial uses perturbation-based training with visual cues on the Neurocom Balance Platform. This technique is designed to enhance both anticipatory and compensatory postural adjustments by teaching participants to anticipate and respond to balance disturbances effectively. The use of visual countdown cues and specific oscillation patterns is a novel way to train the brain and body to work together, potentially offering more consistent and repeatable improvements in balance for TBI patients.

What evidence suggests that this balance training program is effective for preventing falls in people with traumatic brain injuries?

Research has shown that a special type of training using visual signals can improve balance. This trial will evaluate the effectiveness of Perturbation-based Training with visual cues using Neurocom for participants with traumatic brain injuries (TBIs). The training tests the body's ability to stay steady by mimicking sudden movements. For individuals with TBIs, studies have found that this training can enhance balance and reduce the risk of falling. Specifically, one study found that using visual signals during training improves posture and movement. Another review indicated that this training might also aid stroke patients with balance, suggesting potential benefits for TBI patients as well. These findings suggest that the training could effectively help those with TBIs avoid falls. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

This trial is for individuals aged 18-70 who have had a traumatic brain injury (TBI) at least 6 months ago, are medically stable for the past 3 months, can stand unaided for 5 minutes, and agree to follow study procedures without changing medications drastically.

Inclusion Criteria

For Traumatic Brain Injury: Be willing and able to give informed consent

I have been stable for 3 months since my last traumatic brain injury.

For Healthy Individuals: Be willing and able to give informed consent

Exclusion Criteria

For Healthy Individuals: Be currently enrolled in another research study that is likely to affect participation

I do not have conditions affecting my movement or sensation.

I had balance issues before my traumatic brain injury.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline

Initial data collection session for functional, clinical, biomechanical, and physiological metrics

1 week

1 visit (in-person)

Treatment

TBI Intervention group participates in 16 anticipatory and compensatory postural adjustments training sessions using the Neurocom Balance Platform

16 weeks

16 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with data collection on functional, clinical, biomechanical, and physiological metrics

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Perturbation-based Training with visual cues using Neurocom

Trial Overview The trial tests a balance training program using Neurocom's Balance Platform. It aims to improve anticipatory and compensatory postural responses in TBI patients through visual cues and platform oscillations over multiple sessions.

How Is the Trial Designed?

Group I: TBI Intervention Group Experimental Treatment 1 Intervention

Participants will participate in 16 anticipatory postural adjustments (APA) and compensatory postural adjustments (CPA) training sessions using the Neurocom Balance Platform. Each session will last for 1 hour. During the APA portion, a visual cue on the front screen in the form of a countdown timer showing the remaining seconds to the onset of the upcoming perturbation. This information will allow an opportunity for the participant to adjust their posture to handle the upcoming perturbation in the best possible way and also train them to anticipate upcoming disturbances and execute corrective motor outputs. This will ensure the generation of APA in a consistent and repetitive manner. In CPA, after a 5 second pause, the platform will oscillate at 1 Hz, with a constant amplitude, in the anterior-posterior direction for 50 seconds, followed by an additional 5 second quiet period. The participant will wear a safety harness at all times and a spotter will be present at all times.

Group II: TBI Control Group Active Control 1 Intervention

No intervention is provided

Group III: Healthy Control Active Control 1 Intervention

No intervention is provided

Who Is Running the Clinical Trial?

Kessler Foundation

Lead Sponsor

Trials

190

Recruited

11,300+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05268484

Study Details | NCT05268484 | Improving Anticipatory and ... The purpose of this study is to assess a balance training program to see if it can be helpful to avoid falls in people who have had traumatic brain injuries ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11534169/

The Impact of Visual Perturbation Neuromuscular Training ... VPNT provides a clinically feasible means to perturbate visual processing during training that improves athletes' real-time landing mechanics and promotes ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05130658

Study to Improve Ambulation in Individuals With TBI Using ... The purpose of this research study is to test the effectiveness of virtual reality (VR) based treadmill training on walking ability.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9329815/

A Systematic Review and Meta-Analysis - PMC PBT may improve balance in patients with stroke, however its effect on balance confidence was limited. The quality of the evidence was low or very low.

5. researchgate.net researchgate.net/publication/348057478_Enhancing_sensory_acuity_and_balance_function_using_near-sensory_biofeedback-based_perturbation_intervention_for_individuals_with_traumatic_brain_injury

Enhancing sensory acuity and balance function using near ... Objective: To evaluate the efficacy of a novel intervention that integrates sensory acuity with a perturbation-based approach for improving the perception and ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11119161/

Virtual Reality-Based Interventions to Improve Balance in ... The aim of this study was to determine if stress reactivity and postural control are susceptible to long-term consequences of mild traumatic ...