30 Participants Needed

Robotic Balance Training for Traumatic Brain Injury

KK
Overseen ByKiran Karunakaran, Ph.D.
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Kessler Foundation
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new robotic balance training program designed to help individuals who have suffered a traumatic brain injury (TBI) improve their balance and reduce fall risk. Participants are divided into three groups: one TBI group will undergo 10 training sessions, another TBI group will not receive training, and a third group without disabilities will provide baseline data. Ideal candidates have been diagnosed with TBI between 6 months and 5 years ago, can stand unsupported for 5 minutes, and have no other conditions affecting their balance. Participants will assist researchers in evaluating the effectiveness of this robotic training in improving balance after a TBI. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance rehabilitation options for TBI patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you should not plan to 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 robotic balance training is safe for people with traumatic brain injuries?

Research has shown that robotic balance training can be safe for people with brain injuries. One study demonstrated that robotic devices used to assist walking led to similar functional improvements in patients with brain injuries, suggesting the treatment is well-tolerated. Other studies have found that similar robotic and virtual reality (VR) therapies are safe and generally well-received by patients, indicating that adverse reactions are uncommon.

Although this trial phase does not specifically test safety, using robotic training in similar situations has shown promise. It's important to understand that these findings don't guarantee a risk-free experience, but they do provide encouraging safety evidence.12345

Why are researchers excited about this trial?

Researchers are excited about robotic balance training for traumatic brain injury because it offers a unique approach compared to traditional therapies like physical therapy and balance exercises. This method uses the Hunova robotic device to deliver customized sessions that challenge patients to maintain balance on an unstable platform, with tasks like standing on one leg or performing head rotations. Unlike standard treatments that may be less interactive, this robotic technique provides real-time feedback and a safe, controlled environment to enhance balance and coordination, which could lead to more effective rehabilitation outcomes for patients with traumatic brain injuries.

What evidence suggests that robotic balance training is effective for improving balance in people with traumatic brain injuries?

Research shows that robotic balance training, which participants in this trial may receive, can enhance balance and stability for people with traumatic brain injuries (TBIs). Studies indicate that this training helps the brain use areas important for movement and balance more effectively. Some trials found improvements in the body's ability to stay upright, suggesting that robotic training might reduce the risk of falls for those with TBIs. Although more research is needed, early results are promising for individuals dealing with balance issues after a brain injury.12346

Who Is on the Research Team?

KK

Kiran Karunakaran

Principal Investigator

Kessler Foundation

Are You a Good Fit for This Trial?

This trial is for individuals who have experienced a traumatic brain injury (TBI) and are looking to improve their balance. Participants should be able to stand unaided. The study excludes those with other neurological disorders, recent surgery, or conditions that might interfere with balance training.

Inclusion Criteria

I have been medically stable for 3 months before my last traumatic brain injury.
I won't change my medications significantly for the next 4 weeks.
I can stand by myself for 5 minutes.
See 3 more

Exclusion Criteria

My weight is over 300 lbs.
Be currently enrolled in another research study that is likely to affect participation in this research study
I have a condition that significantly affects my leg's function or alignment when standing.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

TBI intervention group participates in 10 robotic balance training sessions using the Hunova robotic device, each lasting up to 1.5 hours.

5 weeks
10 visits (in-person)

Data Collection

TBI non-intervention group participates in two data collection sessions approximately 5 weeks apart. Participants without disability group participates in one data collection session.

5 weeks
2 visits (in-person) for TBI non-intervention group, 1 visit (in-person) for participants without disability group

Follow-up

Participants are monitored for safety and effectiveness after treatment through various assessments including the 10 Meter Walk Test, Berg Balance Assessment, and others.

5 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Robotic Balance Training
Trial Overview The study tests a robotic balance training program's effectiveness on improving postural control in TBI patients. It includes three groups: one receiving the intervention, another TBI group not receiving it, and a non-disabled group for comparison.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Active Control
Group I: TBI - Intervention GroupExperimental Treatment1 Intervention
Group II: Participants without disability groupActive Control1 Intervention
Group III: TBI - Non Intervention GroupActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Kessler Foundation

Lead Sponsor

Trials
190
Recruited
11,300+

Citations

Results From a Randomized Controlled Trial to Address ...This study did not find that VR training was more beneficial than a traditional HEP for improving balance. However, individuals with chronic TBI in both ...
Kiran Karunakaran, PhD, and Vikram Shenoy Handiru ...This intervention will result in improved and efficient recruitment of cognitive and sensorimotor brain regions during gait and balance and will ...
NEUROBALANCE Training to Improve Postural Control in ...Our proposed study, "NEUROBALANCE," aims to evaluate the effectiveness of a combined intervention involving robotic balance training and noninvasive ...
Robotic Balance Training to Improve Postural Control and ...The purpose of this study is to assess a balance training program to see if it can be helpful to improve balance and avoid falls in people who ...
Effect of robotic-assisted gait training on functional ...These results indicate that robotic walking devices, when used for gait training in patients with acquired brain injury, led to similar improvements in FIM ...
Virtual reality for balance and mobility rehabilitation ...The VR intervention is safe and well-tolerated in patients with TBI. · The effects of VR on balance and mobility post-TBI are promising. · The optimal VR ...
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