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

NCT06719297 | Not Yet Recruiting DMC

• 2 other identifiers: R-1276-2490IFRE0092
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild Cognitive Impairment

Keywords

older adults, mild cognitive impairment, gait, balance

Outcome Measures

Primary Outcomes (17)

• Timed Up and Go (TUG)

  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 weeks

• 10 Meter walk test

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

  10 weeks

• Berg balance Assessment

  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.

  10 weeks

• Fall Risk

  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.

  10 weeks

• Balance

  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.

  10 weeks

• Temporal characteristics

  This test assesses deviations in timing of steps during walking.

  10 weeks

• Spatial characteristics

  This test assesses deviations in steplength during walking.

  10 weeks

• Physiological

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

  10 weeks

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

  This test assesses attention and working memory.

  10 weeks

• Flanker Inhibitory Control and Attention Test

  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.

  10 weeks

• Symbol Digit Modalities Test (SDMT)

  This test assesses processing speed without a motor component

  10 weeks

• Paced Auditory Serial Addition Test (PASAT)

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

  10 weeks

• Letter-Number Sequencing (WAIS-IV)

  This test assesses working memory

  10 weeks

• Delis-Kaplan Executive Function System

  Selected subtests to assess executive function.

  10 weeks

• Community Ambulation

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

  10 weeks

• Continuous Performance Task

  This test assesses attention.

  10 weeks

• Magnetic Resonance Imaging (MRI)

  MRI scans will be performed to assess the structure and function of the brain while the participant is lying quietly in the MRI scanner.

  1 week

Secondary Outcomes (2)

• 6 Minute Walk Test

  10 weeks

• Dynamic Gait Index (DGI)

  10 weeks

Study Arms (2)

Personalized cognitive-sensorimotor VR/MR training

EXPERIMENTAL

Thinking task integrated walking and balance training program

Other: Personalized cognitive-sensorimotor VR/MR training

Standard of Care

ACTIVE COMPARATOR

Standard walking and balance training

Other: Standard of Care

Interventions

Personalized cognitive-sensorimotor VR/MR training OTHER

Thinking task integrated walking and balance training program

Personalized cognitive-sensorimotor VR/MR training

Standard of Care OTHER

Standard walking and balance training

Standard of Care

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kessler Foundation: lead
• Rutgers University: collaborator
• New Jersey Institute of Technology: collaborator

Study Sites (1)

Kessler Foundation

West Orange, New Jersey, 07052, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Kiran Karunakaran

  Kessler Foundation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kiran Karunakaran, PhD

CONTACT

5513583672; kirankarun@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist, Principal Investigator

Study Record Dates

• First Submitted: November 18, 2024
• First Posted: December 5, 2024
• Study Start: December 1, 2024
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: December 5, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)