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

Kessler Foundation

Status: Not yet enrolling

Conditions: Mild Cognitive Impairment

Treatments: Other: Standard of Care; Other: Personalized cognitive-sensorimotor VR/MR training

Study type: Interventional

Funder types: Other

Identifiers

NCT06719297

R-1276-24

90IFRE0092 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 65 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Personalized cognitive-sensorimotor VR/MR training

Experimental group

Description:

Thinking task integrated walking and balance training program

Treatment:

Other: Personalized cognitive-sensorimotor VR/MR training

Standard of Care

Active Comparator group

Description:

Standard walking and balance training

Treatment:

Other: Standard of Care