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

Not Applicable

Not yet recruiting

• Conditions: Mild Cognitive Impairment

• Registration Number: NCT06719297
• Lead Sponsor: Kessler Foundation

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-11-18
• Status Verified: 2024-12
• Study Start: 2024-12-01
• Study First Submitted QC: 2024-12-02
• Last Update Submitted: 2024-12-02
• Study First Posted: 2024-12-05
• Last Update Posted: 2024-12-05
• Primary Completion: 2027-08-31
• Study Completion: 2027-08-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 test	10 weeks	Participants will be asked to walk about 12 meters. The time taken to walk 10 meters will be recorded.
Temporal characteristics	10 weeks	This test assesses deviations in timing of steps during walking.
Symbol Digit Modalities Test (SDMT)	10 weeks	This test assesses processing speed without a motor component
Berg balance Assessment	10 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 Risk	10 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.
Balance	10 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.
Spatial characteristics	10 weeks	This test assesses deviations in steplength during walking.
Physiological	10 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 Test	10 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.
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 System	10 weeks	Selected subtests to assess executive function.
Community Ambulation	10 weeks	This test quantifies the amount of physical activity in the community using IMU sensors that participants will wear.
Continuous Performance Task	10 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.

Secondary Outcome Measures

Name	Time	Method
6 Minute Walk Test	10 weeks	Participants walk as far as possible for 6 minutes. They walk back and forth around the cones along an unobstructed pathway of 15 meters. They will be permitted to slow down or stop as necessary. The distance covered by the participant for the 6 minutes will be recorded at an interval of every 30 seconds using a measuring wheel and stop watch.
Dynamic Gait Index (DGI)	10 weeks	DGI is a measurement tool commonly used to assess dynamic balance, gait and risk for falls29. It consists of a total of eight gait assessments which can be scored on a four-point ordinal scale, ranging from 0-3, where '0' indicates the lowest level of function and '3' the highest level of function, allowing for a total possible score of 24.

Trial Locations

Locations (1)

Kessler Foundation; 🇺🇸 West Orange, New Jersey, United States