NCT06473987

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 135 (estimated)
• Sponsor: Kessler Foundation · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Traumatic brain injury (TBI) affects 2.87 million people annually in the US and is a leading cause of long-term disability. TBI impairs both cognitive and sensorimotor functions, with debilitating consequences on ambulation (gait \& balance), which persist during the chronic stages of recovery. Individuals with TBI-induced gait \& balance dysfunction are at a higher risk of falls leading to another TBI. Gait \& balance control is a complex interplay between various cognitive and motor processes, and disruption of any of these processes can severely affect gait \& balance and result in falls. Research examining TBI-related changes in cognitive demands associated with gait \& balance control has shown increased cognitive demand to perform gait \& balance tasks in individuals with TBI, with increases in cognitive demand for more complex tasks. This strong link between cognitive (attention, processing speed \& executive function) and sensorimotor functions is the basis for the proposed project. The investigators aim to strengthen this inseparable link using a novel cognitive-motor intervention. The investigators propose a training regimen, cognitive integrated sensorimotor training (CMT), which increases the cognitive-motor effort to perform the tasks. CMT uses virtual and augmented reality (VR/AR) to employ the cognitive system to perform the motor task in order to train the inseparable cognitive and motor components that are critically important for gait \& balance function. Here the cognitive task is "incorporated" into the motor task, as the cognitive task is a relevant prerequisite for successfully completing the sensorimotor task. The investigators hypothesize that CMT will maximize gait \& balance function and reduce falls in adults with TBI. The study will evaluate the differences between three intervention groups (n=45 each): a) personalized cognitive integrated sensorimotor VR/AR training (CMT), b) traditional dual-task training (CTRL), and c) 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.

Conditions

• Traumatic Brain Injury

Interventions

Type	Name	Description
OTHER	Personalized cognitive-sensorimotor VR/AR training	Thinking task integrated walking and balance training program
OTHER	Traditional dual-task training	Walking and balance training similar to standard of care group but will also perform additional thinking tasks during training
OTHER	Standard of Care	Standard walking and balance training

Timeline

• Start date: 2024-12-01
• Primary completion: 2028-07-31
• Completion: 2028-09-29
• First posted: 2024-06-25
• Last updated: 2024-11-27

Locations

1 site across 1 country: United States