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Robotic Balance Training to Improve Postural Control and Balance Post-Traumatic Brain Injury | Clinical Trials | Clareo Health

RECRUITINGNA

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

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

NCT06184295•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.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Participants with TBI:
•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.
•Be between the ages of 18 and 65.
•Not plan to make any drastic changes to medications for at least 4 weeks.
+4 more criteria

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:
+7 more criteria

Locations (1)

Kessler Foundation

West Orange, New Jersey, United States

Key Dates

Start Date

January 1, 2024

Primary Completion Date

December 31, 2024

Completion Date

December 31, 2024

Last Updated

December 5, 2024

Enrollment

ESTIMATED participants

Conditions

Traumatic Brain Injury

Interventions

TBI - Intervention Group

DEVICE

Contacts

Kiran Karunakaran, Ph.D.

CONTACT

973-324-3590 kkarunakaran@kesslerfoundation.org

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 5, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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