An interventional study of Personalized cognitive-sensorimotor VR/MR training and Standard of Care in Mild Cognitive Impairment, sponsored by Kessler Foundation. Not yet recruiting at 1 site in United States. Open to participants aged 65 Years to 85 Years. Per ClinicalTrials.gov, last updated 2024-12-05.
Sponsored by Kessler Foundation · Not applicable, Interventional, and Treatment
Problems with walking and balance are common in older adults with mild cognitive impairment. 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)/mixed reality (MR) 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 in older adults with mild cognitive impairment.
The study will evaluate the differences between two intervention groups (n=20 each): 1) personalized cognitive integrated sensorimotor VR/MR training (CM), and 3) standard of care (CTRL) on gait, balance, community ambulation, and cognitive functions, as well as underlying biomechanical and neurophysiological mechanisms to understand the changes due to CM.
3,843 studies on the registry are indexed under Cognitive Dysfunction; 1,100 are open to participants now.
This study's planned enrollment of 40 is below the median of 65 across 2,808 interventional studies indexed under Cognitive Dysfunction.
Browse Cognitive Dysfunction studies →Kessler Foundation is the lead sponsor of 170 studies on the registry; 58 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
MRI specific exclusion criteria:
Thinking task integrated walking and balance training program
Other: Personalized cognitive-sensorimotor VR/MR training
Standard walking and balance training
Other: Standard of Care
Thinking task integrated walking and balance training program
Standard walking and balance training
Timed Up and Go (TUG)
TUG is a clinical test of functional gait abilities and dynamic balance. The participants will be asked to walk a distance of 3 meters from a seated position, turn around, walk back to the chair and sit back in the chair. The time taken to perform the task will be recorded using a stop watch. The TUG will be repeated multiple times. The participant may be asked to hold a plastic cup or count backwards by three from a randomly selected number while walking.
Time frame: 10 weeks
10 Meter walk test
Participants will be asked to walk about 12 meters. The time taken to walk 10 meters will be recorded.
Time frame: 10 weeks
Berg balance Assessment
This is a test that measures balance on a 5-point during routine tasks. The participant will be asked to perform 14 tasks involving: sitting, standing, reaching, lifting, and turning.
Time frame: 10 weeks
Fall Risk
The silver index will be measured using the Hunova (Movendo Srl., Italy) to quantify the risk of falls. The Silver Index tasks include static balance while eyes are open or closed, dynamic balance while standing on passive and elastic surfaces, limits of stability, reactive balance during perturbations, 6-meter walk, and sit-to-stand.
Time frame: 10 weeks
Balance
Root-mean-square of COM and COP displacements will be used to quantify balance tasks. COP will be obtained from Hunova. Whole body COM will be obtained using motion capture.
Time frame: 10 weeks
Temporal characteristics
This test assesses deviations in timing of steps during walking.
Time frame: 10 weeks
Spatial characteristics
This test assesses deviations in steplength during walking.
Time frame: 10 weeks
Physiological
The participants will wear small sensors on their body to assess the activity of the brain and muscles during walking and balancing tasks.
Time frame: 10 weeks
Digit Span (Wechsler Adult Intelligence Scale [WAIS-IV])
This test assesses attention and working memory.
Time frame: 10 weeks
Flanker Inhibitory Control and Attention Test
This test assesses the allocation of limited attentional capacities to deal with an abundance of environmental stimulation. The test measures attention and the ability to inhibit response that may interfere with the ability to achieve goals.
Time frame: 10 weeks
Symbol Digit Modalities Test (SDMT)
This test assesses processing speed without a motor component
Time frame: 10 weeks
Paced Auditory Serial Addition Test (PASAT)
This test assesses information processing speed \& ability and working memory
Time frame: 10 weeks
Letter-Number Sequencing (WAIS-IV)
This test assesses working memory
Time frame: 10 weeks
Delis-Kaplan Executive Function System
Selected subtests to assess executive function.
Time frame: 10 weeks
Community Ambulation
This test quantifies the amount of physical activity in the community using IMU sensors that participants will wear.
Time frame: 10 weeks
Continuous Performance Task
This test assesses attention.
Time frame: 10 weeks
Magnetic Resonance Imaging (MRI)
MRI scans will be performed to assess the structure and function of the brain while the participant is lying quietly in the MRI scanner.
Time frame: 1 week
6 Minute Walk Test
Participants walk as far as possible for 6 minutes. They walk back and forth around the cones along an unobstructed pathway of 15 meters. They will be permitted to slow down or stop as necessary. The distance covered by the participant for the 6 minutes will be recorded at an interval of every 30 seconds using a measuring wheel and stop watch.
Time frame: 10 weeks
Dynamic Gait Index (DGI)
DGI is a measurement tool commonly used to assess dynamic balance, gait and risk for falls29. It consists of a total of eight gait assessments which can be scored on a four-point ordinal scale, ranging from 0-3, where '0' indicates the lowest level of function and '3' the highest level of function, allowing for a total possible score of 24.
Time frame: 10 weeks
Plan to share: No
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