RECRUITING

Personalized Cognitive Integrated Motor Training Using Virtual Reality to Improve Gait and Balance

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

Problems with walking and balance are common after traumatic brain injury (TBI). Walking and balance problems limit independence and increase risk for injuries due to falls. The purpose of this research study is to test the effectiveness of training that combines moving and thinking tasks, referred to as Personalized cognitive integrated sensorimotor virtual reality (VR)/augmented reality (AR) training on walking and balance ability. The study will also help to understand the changes in thinking ability and brain activity as a result of this training after a brain injury. The study will evaluate the differences between three intervention groups (n=45 each): 1) personalized cognitive integrated sensorimotor VR/AR training (CMT), 2) traditional dual-task training (CTRL), and 3) standard of care (SOC) on gait, balance, community ambulation, and cognitive functions, as well as underlying biomechanical and neurophysiological mechanisms to understand the changes due to CMT.

Official Title

Personalized Cognitive Integrated Motor Training Using Virtual Reality to Improve Gait and Balance in People with Traumatic Brain Injury

Quick Facts

Study Start:2024-12-01
Study Completion:2028-09-29
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06473987

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:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Be between 18-65 years of age.
  2. * Be a person living with TBI for at least 6 months.
  3. * Be able to follow directions and commands.
  4. * Be able to speak and understand English well as evaluated by a test I will be given by the researchers.
  5. * Not have amnesia (as determined by study staff based on a Post Traumatic Amnesia O-log score of \> 20 on 2 consecutive days)
  6. * Have approval from a physician to participate.
  7. * Have no history of injury or problems with my legs in the past 6 months or any medical issue which would interfere with my ability to bear weight on my legs and walk (such as a bone or muscle injury).
  8. * No double vision (diplopia) or other vision problems (such as nystagmus, as determined by study staff)
  9. * Have joint passive range of motion within normal functional limits for walking as determined by study staff.
  10. * Have a walking speed of less than 0.8 m/s as determined by study staff.
  11. * Be able to stand for 5 minutes.
  1. * I have uncontrolled or unstable seizure disorder (such as epilepsy).
  2. * I have pre-existing condition that makes it difficult for me to exercise (such as diagnosed high blood pressure that is not controlled, heart disease, irregular heart rate or rhythm, or congestive heart failure).
  3. * I have muscle or nervous system problems other than TBI (such as spinal cord injury, multiple sclerosis, or Parkinson's disease)
  4. * Have any joint or muscle tightness that would limit my movement while walking.
  5. * I have any medical issue that prevents me from supporting my weight (such as bone or muscle injuries, pain, or severe muscle spasms).
  6. * I have been diagnosed with cognitive (thinking) problems prior to TBI.
  7. * I have severe dizziness (Dizziness Handicap Inventory score greater than 54 (as measured by study staff).
  8. * I have skin issues that would prevent me from wearing a safety harness.

Contacts and Locations

Study Contact

Kiran K Karunakaran, Ph.D.
CONTACT
973-324-3590
kkarunakaran@kesslerfoundation.org

Principal Investigator

Kiran K Karunakaran, PhD
PRINCIPAL_INVESTIGATOR
Kessler Foundation

Study Locations (Sites)

Kessler Foundation
West Orange, New Jersey, 07052
United States

Collaborators and Investigators

Sponsor: Kessler Foundation

  • Kiran K Karunakaran, PhD, 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 Date2024-12-01
Study Completion Date2028-09-29

Study Record Updates

Study Start Date2024-12-01
Study Completion Date2028-09-29

Terms related to this study

Keywords Provided by Researchers

  • Traumatic Brain Injury
  • Gait
  • Balance
  • Cognition
  • Ambulation

Additional Relevant MeSH Terms

  • Traumatic Brain Injury