RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2024-01-01

Study Completion:2024-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06184295

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

Kiran Karunakaran, Ph.D.

CONTACT

973-324-3590

kkarunakaran@kesslerfoundation.org

Principal Investigator

Kiran Karunakaran

PRINCIPAL_INVESTIGATOR

Kessler Foundation

Study Locations (Sites)

Kessler Foundation

West Orange, New Jersey, 07052

United States

Collaborators and Investigators

Sponsor: Kessler Foundation

Kiran Karunakaran, PRINCIPAL_INVESTIGATOR, Kessler Foundation

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-01

Study Completion Date2024-12-31

Study Record Updates

Study Start Date2024-01-01

Study Completion Date2024-12-31

Terms related to this study

Additional Relevant MeSH Terms

Traumatic Brain Injury