Cognitive Integrated Motor Training for Mild Cognitive Impairment

This study is testing a new type of training called Personalized cognitive-sensorimotor VR/MR training. This training combines thinking tasks with walking and balance exercises using virtual or mixed reality. It's designed for older adults (ages 65-85) who have mild cognitive impairment (problems with memory or thinking). The goal is to see if this training can improve walking and balance, reduce falls, and also affect thinking ability and brain activity. Researchers will compare this new training to standard walking and balance training. They will measure improvements in walking and balance after 10 weeks. The study plans to enroll 40 participants, but its current status is unclear.

Study design
This study is an interventional study planning to enroll 40 participants. It compares two types of training: Personalized cognitive-sensorimotor VR/MR training and Standard of Care.
What's involved
Participants will receive either Personalized cognitive-sensorimotor VR/MR training or standard walking and balance training. Walking and balance will be measured at 10 weeks.
Compensation
Not stated in the trial record.
Follow-up
Participants' walking and balance will be assessed at 10 weeks after the start of the training.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06719297

Cognitive Integrated Motor Training (CM) to Improve Gait and Balance and Reduce Falls in Older Adults With Mild Cognitive Impairment

Not Yet Recruiting
NAAges 65–85InterventionalTreatment
Kessler Foundation
~40 participants
Updated 2024-12-05 on ClinicalTrials.gov
What's tested:Personalized cognitive-sensorimotor VR/MR trainingStandard of Care

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Timed Up and Go (TUG)
Measured over 10 weeks
+16 more outcomes measured
Mild Cognitive Impairment

NCT06719297

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Kessler Foundation

    West Orange, New Jerseystudy coordinator listed

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

  • Kiran Karunakaran · PRINCIPAL_INVESTIGATOR · Kessler Foundation

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Eligibility criteria

Inclusion

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

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.
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.
  • Timed Up and Go (TUG)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.

  • 10 Meter walk test10 weeks

    Participants will be asked to walk about 12 meters. The time taken to walk 10 meters will be recorded.

  • Berg balance Assessment10 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.

  • Fall Risk10 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.

  • Balance10 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.

  • Temporal characteristics10 weeks

    This test assesses deviations in timing of steps during walking.

  • Spatial characteristics10 weeks

    This test assesses deviations in steplength during walking.

  • Physiological10 weeks

    The participants will wear small sensors on their body to assess the activity of the brain and muscles during walking and balancing tasks.

  • Digit Span (Wechsler Adult Intelligence Scale [WAIS-IV])10 weeks

    This test assesses attention and working memory.

  • Flanker Inhibitory Control and Attention Test10 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.

  • Symbol Digit Modalities Test (SDMT)10 weeks

    This test assesses processing speed without a motor component

  • Paced Auditory Serial Addition Test (PASAT)10 weeks

    This test assesses information processing speed \& ability and working memory

  • Letter-Number Sequencing (WAIS-IV)10 weeks

    This test assesses working memory

  • Delis-Kaplan Executive Function System10 weeks

    Selected subtests to assess executive function.

  • Community Ambulation10 weeks

    This test quantifies the amount of physical activity in the community using IMU sensors that participants will wear.

  • Continuous Performance Task10 weeks

    This test assesses attention.

  • Magnetic Resonance Imaging (MRI)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.