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

Official title

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

Overview

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.

Interventions

• 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

Primary outcome measures

• 10 Meter walk test [Time frame: 10 weeks]
• Timed Up and Go (TUG) [Time frame: 10 weeks]
• Berg balance Assessment: [Time frame: 10 weeks]
• Digit Span (Wechsler Adult Intelligence Scale [WAIS-IV]) [Time frame: 10 weeks]
• Flanker Inhibitory Control and Attention Test [Time frame: 10 weeks]
• Symbol Digit Modalities Test (SDMT) [Time frame: 10 weeks]
• Paced Auditory Serial Addition Test (PASAT) [Time frame: 10 weeks]
• Letter-Number Sequencing (WAIS-IV) [Time frame: 10 weeks]
• Delis-Kaplan Executive Function System [Time frame: 10 weeks]
• Hopkins Verbal Learning Test Revised [Time frame: 10 weeks]

Secondary outcome measures (9)

• 6 Minute Walk Test [Time frame: 10 weeks]
• Dynamic Gait Index (DGI) [Time frame: 10 weeks]
• Walking While Talking Test [Time frame: 10 weeks]
• Area under the curve (AOC) [Time frame: 10 weeks]
• minimum change in O2Hb [Time frame: 10 weeks]
• functional connectivity [Time frame: 10 weeks]
• Electromyography [Time frame: 10 weeks]
• Community Integration Questionnaire (CIT) [Time frame: 10 weeks]
• Patient Competency Rating Scale (PCRS) [Time frame: 10 weeks]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

United States · 1 center

• Kessler Foundation — West Orange

Identifiers

NCT: NCT06473987 · R-1262-24 · TP230307

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗