Kessler Foundation
West Orange, New Jersey, 07052, United States
Location contact
Kiran Karunakaran, PhD
CONTACT
Kiran Karunakaran, PhD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT06719297
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.
Trial opening soon.
Get Notified65 year–85 year
All sexes
Interventional
Not applicable
West Orange, New Jersey, 07052, United States
Kiran Karunakaran, PhD
CONTACT
Kiran Karunakaran, PhD
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
MRI specific exclusion criteria:
Thinking task integrated walking and balance training program
Standard walking and balance training
Time frame: 10 weeks
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
Participants will be asked to walk about 12 meters. The time taken to walk 10 meters will be recorded.
Time frame: 10 weeks
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
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
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
This test assesses deviations in timing of steps during walking.
Time frame: 10 weeks
This test assesses deviations in steplength during walking.
Time frame: 10 weeks
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
This test assesses attention and working memory.
Time frame: 10 weeks
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
This test assesses processing speed without a motor component
Time frame: 10 weeks
This test assesses information processing speed & ability and working memory
Time frame: 10 weeks
This test assesses working memory
Time frame: 10 weeks
Selected subtests to assess executive function.
Time frame: 10 weeks
This test quantifies the amount of physical activity in the community using IMU sensors that participants will wear.
Time frame: 10 weeks
This test assesses attention.
Time frame: 1 week
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: 10 weeks
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
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.
Contact information is provided by the study sponsor or research team.
Kessler Foundation
Other
Cognitive Integrated Motor Training to Improve Gait and Balance and Reduce Falls in Older Adults With Mild Cognitive Impairment
Acronym: CM
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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