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

Phase

N/A

Condition

Traumatic Brain Injury

Memory Loss

Neurologic Disorders

Treatment

Personalized cognitive-sensorimotor VR/AR training

Standard of Care

Traditional dual-task training

Clinical Study ID

NCT06473987

R-1262-24

TP230307

Ages 18-65
All Genders

Study 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

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 givenby the researchers.
Not have amnesia (as determined by study staff based on a Post Traumatic AmnesiaO-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 anymedical issue which would interfere with my ability to bear weight on my legs andwalk (such as a bone or muscle injury).
No double vision (diplopia) or other vision problems (such as nystagmus, asdetermined by study staff)
Have joint passive range of motion within normal functional limits for walking asdetermined 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

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 asdiagnosed high blood pressure that is not controlled, heart disease, irregular heartrate 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 ormuscle 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 (asmeasured by study staff).
I have skin issues that would prevent me from wearing a safety harness.

Study Design

Personalized cognitive-sensorimotor VR/AR training

December 01, 2024

September 29, 2028

Study 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.

Connect with a study center

Kessler Foundation
West Orange, New Jersey 07052
United States
Active - Recruiting

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