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

Last updated: December 2, 2024
Sponsor: Kessler Foundation
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Dementia

Memory Loss

Mild Cognitive Impairment

Treatment

Personalized cognitive-sensorimotor VR/MR training

Standard of Care

Clinical Study ID

NCT06719297
R-1276-24
90IFRE0092
  • Ages 65-85
  • All Genders

Study 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

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 isunavailable the study team clinician will provide the medical clearance.

  • Adequate cognitive function to give informed consent, understand the training andinstructions, use the device and give adequate feedback.

  • Able to stand for 5 minutes.

Exclusion

Exclusion Criteria:

  • Body weight over 135 kgs.

  • Uncontrolled or unstable seizure disorder.

  • Severe joint contracture or spasticity of the ankle that limits passive range ofmotion as determined by the team.

  • History of severe cardiac diseases such as myocardial infarction, coronary arterydisease, cardiac arrhythmia, or congestive heart failure.

  • Neuromuscular or neurological pathologies (e.g., spinal cord injury, stroke) thatwill interfere with ambulation.

  • Uncontrolled or unstable orthostatic hypotension.

  • Pre-existing conditions resulting in significant disruption in alignment or functionof the lower limb during standing.

  • History of injury or pathology to the lower limbs in the past 6 months or anymedical issue precludes full weight-bearing and ambulation (e.g., orthopedicinjuries).

  • Diplopia or nystagmus.

  • Walking speed from 10MWT >0.8m/s.

MRI specific exclusion criteria:

  • Medications such as: steroids, benzodiazepines, and neuroleptics. The study doctorwill review the medications with the participant.

  • clip to repair a cerebral aneurysm (broken blood vessel in the head), cardiacpace-maker, cochlear implants (internal hearing aids) or metal fragments or piecesin 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 regularMRI.

  • Engage in the professions of painting or welding or other occupation that preventsme from getting a regular MRI.

  • claustrophobia (fear of enclosed spaces).

  • History of schizophrenia or bipolar disorder.

Study Design

Total Participants: 40
Treatment Group(s): 2
Primary Treatment: Personalized cognitive-sensorimotor VR/MR training
Phase:
Study Start date:
December 01, 2024
Estimated Completion Date:
August 31, 2027

Connect with a study center

  • Kessler Foundation

    West Orange, New Jersey 07052
    United States

    Site Not Available

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