Robotic Balance Training for Traumatic Brain Injury
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.12345Why 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?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
TBI intervention group participates in 10 robotic balance training sessions using the Hunova robotic device, each lasting up to 1.5 hours.
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.
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.
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?
3
Treatment groups
Experimental Treatment
Active Control
The participants will receive 10 customized robotic balance training sessions to improve balance using the Hunova robotic device. Each session will last for up to 1.5 hours. The training may include standing or sitting on the robotic balance platform and performing the following tasks: maintaining balance when the platform becomes unstable or moving in various directions, or in an inclination; these tasks may be performed as instructed with eyes open or eyes closed condition; move in different directions to reach targets with my hands; stand on one leg or heel to toe and maintain balance; perform head or torso rotation while standing or sitting. All training will be performed with an overhead harness and a spotter will be present at all times.
Participants will receive no intervention
Participants will receive no intervention
Find a Clinic Near You
Who Is Running the Clinical Trial?
Kessler Foundation
Lead Sponsor
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 ...
2.
kesslerfoundation.org
kesslerfoundation.org/press-release/kessler-foundation-researchers-advance-traumatic-brain-injury-rehabilitationKiran 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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