NCT06473987 Personalized Cognitive Integrated Motor Training Using Virtual Reality to Improve Gait and Balance
| NCT ID | NCT06473987 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Kessler Foundation |
| Condition | Traumatic Brain Injury |
| Study Type | INTERVENTIONAL |
| Enrollment | 135 participants |
| Start Date | 2024-12-01 |
| Primary Completion | 2028-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 135 participants in total. It began in 2024-12-01 with a primary completion date of 2028-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Be between 18-65 years of age. * Be a person living with TBI for at least 6 months. * Be able to follow directions and commands. * Be able to speak and understand English well as evaluated by a test I will be given by the researchers. * Not have amnesia (as determined by study staff based on a Post Traumatic Amnesia O-log score of \> 20 on 2 consecutive days) * Have approval from a physician to participate. * 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). * No double vision (diplopia) or other vision problems (such as nystagmus, as determined by study staff) * Have joint passive range of motion within normal functional limits for walking as determined by study staff. * Have a walking speed of less than 0.8 m/s as determined by study staff. * Be able to stand for 5 minutes. Exclusion Criteria: * I have uncontrolled or unstable seizure disorder (such as epilepsy). * 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). * I have muscle or nervous system problems other than TBI (such as spinal cord injury, multiple sclerosis, or Parkinson's disease) * Have any joint or muscle tightness that would limit my movement while walking. * I have any medical issue that prevents me from supporting my weight (such as bone or muscle injuries, pain, or severe muscle spasms). * I have been diagnosed with cognitive (thinking) problems prior to TBI. * I have severe dizziness (Dizziness Handicap Inventory score greater than 54 (as measured by study staff). * I have skin issues that would prevent me from wearing a safety harness.
Contact & Investigator
Kiran K Karunakaran, PhD
PRINCIPAL INVESTIGATOR
Kessler Foundation
Frequently Asked Questions
Who can join the NCT06473987 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Traumatic Brain Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06473987 currently recruiting?
Yes, NCT06473987 is actively recruiting participants. Contact the research team at kkarunakaran@kesslerfoundation.org for enrollment information.
Where is the NCT06473987 trial being conducted?
This trial is being conducted at West Orange, United States.
Who is sponsoring the NCT06473987 clinical trial?
NCT06473987 is sponsored by Kessler Foundation. The principal investigator is Kiran K Karunakaran, PhD at Kessler Foundation. The trial plans to enroll 135 participants.