Ignite Creation Date:
2024-07-17 @ 10:55 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06473987
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-01
First Post:
2024-06-19
Brief Title:
Personalized Cognitive Integrated Motor Training Using Virtual Reality to Improve Gait and Balance
Sponsor:
Kessler Foundation
Organization:
Kessler Foundation
Study Overview
Official Title:
Personalized Cognitive Integrated Motor Training Using Virtual Reality to Improve Gait and Balance in People With Traumatic Brain Injury
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CMT
Brief 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 VRaugmented 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 n45 each 1 personalized cognitive integrated sensorimotor VRAR 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
The study will evaluate the differences between three intervention groups n45 each 1 personalized cognitive integrated sensorimotor VRAR 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 287 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 VRAR 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 n45 each a personalized cognitive integrated sensorimotor VRAR 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
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 VRAR 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 n45 each a personalized cognitive integrated sensorimotor VRAR 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| TP230307 | OTHER_GRANT | None | None |