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RECRUITING

NCT06184295

Robotic Balance Training to Improve Postural Control and Balance Post-Traumatic Brain Injury

Sponsor: Kessler Foundation

View on ClinicalTrials.gov

Summary

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.

Official title: Robotic Balance Training to Improve Postural Control and Balance Post-Traumatic Brain

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2024-01-01

Completion Date

2024-12-31

Last Updated

2024-12-05

Healthy Volunteers

Yes

Conditions

Traumatic Brain Injury

Interventions

DEVICE

TBI - Intervention Group

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 with TBI: Inclusion Criteria: * Be between the ages of 18 and 65. * Have been diagnosed with a TBI by a physician and be at least 6 months post injury and not more than 5 years post injury. * Have been medically stable for 3 months prior to the most recent TBI. * Not plan to make any drastic changes to medications (as determined by study staff) for at least 4 weeks. * Be able to stand unsupported for 5 minutes. * Be willing and able to give informed consent. * Be able and willing to comply with study procedures, verbal instructions, and follow-up requirements. Exclusion Criteria: * Weight above 300 lbs. * Have severe cardiac disease such as heart attack or moderate or severe congestive heart failure. * Have a pre-existing condition resulting in significant disruption in alignment or function of the lower limb during standing. * Have additional medical conditions that affect the bones, muscles or nerves that would interfere with the balance. * Have any previously diagnosed history of balance problems prior to TBI. * Have fluctuating blood pressure. * Be on any medication that may affect balance, strength, or muscle coordination (e.g. Botox). * Be currently enrolled in another research study that is likely to affect participation in this research study. * Have seizure disorder. Participants without a disability: Inclusion Criteria: * Be between the ages of 18 and 65. * Not plan to make any drastic changes to medications for at least 4 weeks. * Not have an orthopedic, cognitive or neuromuscular disease. * Be able to stand unsupported for 5 minutes. * Be willing and able to give informed consent. * Be able and willing to comply with study procedures, including follow-up requirements. Exclusion Criteria: * Weight above 300 lbs. * Have a history of injury to my lower limbs in the past 90 days. * Have severe cardiac disease such as heart attack or moderate or severe congestive heart failure. * Have a pre-existing condition resulting in significant disruption in alignment or function of the lower limb during standing. * Have any additional medical conditions that affect my bones, muscles, or nerves that would interfere with the movement or the ability to feel touch or pain. * Have difficulty following or responding to commands that would limit the study participation. * Be currently enrolled in another research study that is likely to affect participation in this research study.

Locations (1)

Kessler Foundation

West Orange, New Jersey, United States