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

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.

NCT Number	NCT06473987
Lead Sponsor	Kessler Foundation Collaborators: Massachusetts General Hospital
Conditions	Traumatic Brain Injury
Enrollment	135 participants
Start Date	2024-12-01
Primary Completion	2028-07-31 (estimated)
Study Completion	2028-09-29 (estimated)
Updated on ClinicalTrials.gov	2024-11-27