Robotic Balance Training for Traumatic Brain Injury

Overseen By Kiran Karunakaran, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Kessler Foundation

Must not be taking: Botox

Disqualifiers: Severe cardiac disease, Seizure disorder, others

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

Compensation: Varies

Number of Visits: 12

Duration: 5 weeks

30 Participants Needed

Trial Summary

What is the purpose of this trial?

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 have had traumatic brain injuries (TBIs). The study will involve three groups of research subjects: 1) TBI-intervention group, 2) TBI- non-intervention group and 3) the participants without disability group. The TBI intervention Group will participate in 10 robotic balance training sessions. Data will collected pre and post-training. TBI- non-intervention group will not receive any training. They will participate in two data collection sessions which are about 5 weeks apart. The participants without disability group will not receive any training. They will participate in one data collection session.

Research Team

Kiran Karunakaran

Principal Investigator

Kessler Foundation

Eligibility Criteria

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.

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.

Timeline

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

Treatment Details

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.

Participant Groups

Group I: TBI - Intervention Group Experimental Treatment 1 Intervention

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.

Group II: Participants without disability group Active Control 1 Intervention

Participants will receive no intervention

Group III: TBI - Non Intervention Group Active Control 1 Intervention

Participants will receive no intervention

Who Is Running the Clinical Trial?

Kessler Foundation

Lead Sponsor

Trials

190

Recruited

11,300+