Personalized Cognitive Integrated Motor Training Using Virtual Reality to Improve Gait and Balance
NCT ID: NCT06473987
Last Updated: 2024-11-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
135 participants
INTERVENTIONAL
2024-12-01
2028-09-29
Brief Summary
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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
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Personalized cognitive-sensorimotor VR/AR training
Thinking task integrated walking and balance training program
Personalized cognitive-sensorimotor VR/AR training
Thinking task integrated walking and balance training program
Traditional dual-task training
Walking and balance training similar to standard of care group but will also perform additional thinking tasks during training.
Traditional dual-task training
Walking and balance training similar to standard of care group but will also perform additional thinking tasks during training
Standard of Care
Standard walking and balance training
Standard of Care
Standard walking and balance training
Interventions
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Personalized cognitive-sensorimotor VR/AR training
Thinking task integrated walking and balance training program
Traditional dual-task training
Walking and balance training similar to standard of care group but will also perform additional thinking tasks during training
Standard of Care
Standard walking and balance training
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
65 Years
ALL
No
Sponsors
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Massachusetts General Hospital
OTHER
Kessler Foundation
OTHER
Responsible Party
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Principal Investigators
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Kiran K Karunakaran, PhD
Role: PRINCIPAL_INVESTIGATOR
Kessler Foundation
Locations
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Kessler Foundation
West Orange, New Jersey, United States
Countries
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Central Contacts
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Other Identifiers
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TP230307
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
R-1262-24
Identifier Type: -
Identifier Source: org_study_id