Cognitive Integrated Motor Training (CM) to Improve Gait and Balance and Reduce Falls in Older Adults With Mild Cognitive Impairment
NCT ID: NCT06719297
Last Updated: 2024-12-05
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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NOT_YET_RECRUITING
NA
40 participants
INTERVENTIONAL
2024-12-01
2027-08-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Personalized cognitive-sensorimotor VR/MR training
Thinking task integrated walking and balance training program
Personalized cognitive-sensorimotor VR/MR training
Thinking task integrated walking and balance training program
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/MR training
Thinking task integrated walking and balance training program
Standard of Care
Standard walking and balance training
Eligibility Criteria
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Inclusion Criteria
* Montreal Cognitive Assessment (MOCA), 17 \< MOCA \< 24
* Medical clearance will be obtained from my clinician. If participants physician is unavailable the study team clinician will provide the medical clearance.
* Adequate cognitive function to give informed consent, understand the training and instructions, use the device and give adequate feedback.
* Able to stand for 5 minutes.
Exclusion Criteria
* Uncontrolled or unstable seizure disorder.
* Severe joint contracture or spasticity of the ankle that limits passive range of motion as determined by the team.
* History of severe cardiac diseases such as myocardial infarction, coronary artery disease, cardiac arrhythmia, or congestive heart failure.
* Neuromuscular or neurological pathologies (e.g., spinal cord injury, stroke) that will interfere with ambulation.
* Uncontrolled or unstable orthostatic hypotension.
* Pre-existing conditions resulting in significant disruption in alignment or function of the lower limb during standing.
* History of injury or pathology to the lower limbs in the past 6 months or any medical issue precludes full weight-bearing and ambulation (e.g., orthopedic injuries).
* Diplopia or nystagmus.
* Walking speed from 10MWT \>0.8m/s.
* Medications such as: steroids, benzodiazepines, and neuroleptics. The study doctor will review the medications with the participant.
* clip to repair a cerebral aneurysm (broken blood vessel in the head), cardiac pace-maker, cochlear implants (internal hearing aids) or metal fragments or pieces in the eyes or any other part of the body.
* non MRI compatible metal in any part of the body.
* Medical clearance from a physician that it is medically unsafe to receive regular MRI.
* Engage in the professions of painting or welding or other occupation that prevents me from getting a regular MRI.
* claustrophobia (fear of enclosed spaces).
* History of schizophrenia or bipolar disorder.
65 Years
85 Years
ALL
No
Sponsors
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Rutgers University
OTHER
New Jersey Institute of Technology
OTHER
Kessler Foundation
OTHER
Responsible Party
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Kiran Karunakaran
Research Scientist, Principal Investigator
Principal Investigators
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Kiran Karunakaran
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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Facility Contacts
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Kiran Karunakaran, PhD
Role: primary
Other Identifiers
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90IFRE0092
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
R-1276-24
Identifier Type: -
Identifier Source: org_study_id