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

Kessler Foundation

Status: Enrolling

Conditions: Traumatic Brain Injury

Treatments: Other: Traditional dual-task training; Other: Standard of Care; Other: Personalized cognitive-sensorimotor VR/AR training

Study type: Interventional

Funder types: Other

Identifiers

NCT06473987

R-1262-24

TP230307 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 135 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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135 participants in 3 patient groups

Personalized cognitive-sensorimotor VR/AR training

Experimental group

Description:

Thinking task integrated walking and balance training program

Treatment:

Other: Personalized cognitive-sensorimotor VR/AR training

Traditional dual-task training

Active Comparator group

Description:

Walking and balance training similar to standard of care group but will also perform additional thinking tasks during training.

Treatment:

Other: Traditional dual-task training

Standard of Care

Active Comparator group

Description:

Standard walking and balance training

Treatment:

Other: Standard of Care