Clinical trial NCT06719297: Cognitive Integrated Motor Training (CM) to Improve Gait and Balance and Reduce Falls in Older Adults With Mild Cognitive Impairment
Official title: Cognitive Integrated Motor Training to Improve Gait and Balance and Reduce Falls in Older Adults With Mild Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Mild Cognitive Impairment
Keywords: older adults, mild cognitive impairment, gait, balance
Lead sponsor: Kessler Foundation
Sponsor class: OTHER
Collaborators: name: Rutgers University
name: New Jersey Institute of Technology
First posted: 2024-12-05
Enrollment: 40
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Between the age of 65 and 85 years for older adults.
* 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:

* Body weight over 135 kgs.
* 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.

MRI specific exclusion criteria:

* 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.

Primary outcomes:
measure: Timed Up and Go (TUG)
timeFrame: 10 weeks
measure: 10 Meter walk test
timeFrame: 10 weeks
measure: Berg balance Assessment
timeFrame: 10 weeks
measure: Fall Risk
timeFrame: 10 weeks
measure: Balance
timeFrame: 10 weeks
measure: Temporal characteristics
timeFrame: 10 weeks
measure: Spatial characteristics
timeFrame: 10 weeks
measure: Physiological
timeFrame: 10 weeks
measure: Digit Span (Wechsler Adult Intelligence Scale [WAIS-IV])
timeFrame: 10 weeks
measure: Flanker Inhibitory Control and Attention Test
timeFrame: 10 weeks
measure: Symbol Digit Modalities Test (SDMT)
timeFrame: 10 weeks
measure: Paced Auditory Serial Addition Test (PASAT)
timeFrame: 10 weeks
measure: Letter-Number Sequencing (WAIS-IV)
timeFrame: 10 weeks
measure: Delis-Kaplan Executive Function System
timeFrame: 10 weeks
measure: Community Ambulation
timeFrame: 10 weeks
measure: Continuous Performance Task
timeFrame: 10 weeks
measure: Magnetic Resonance Imaging (MRI)
timeFrame: 1 week
Secondary outcomes:
measure: 6 Minute Walk Test
timeFrame: 10 weeks
measure: Dynamic Gait Index (DGI)
timeFrame: 10 weeks
Other outcomes:
Locations:
city: West Orange
country: United States
facility: Kessler Foundation
state: New Jersey
Study officials:
affiliation: Kessler Foundation
name: Kiran Karunakaran
role: PRINCIPAL_INVESTIGATOR
References: