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

Официальное название

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

Обзор

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.

Вмешательства

• Другое Personalized cognitive-sensorimotor VR/MR training
  Thinking task integrated walking and balance training program
• Другое Standard of Care
  Standard walking and balance training

Первичные конечные точки

• Timed Up and Go (TUG) [Срок оценки: 10 weeks]
• 10 Meter walk test [Срок оценки: 10 weeks]
• Berg balance Assessment [Срок оценки: 10 weeks]
• Fall Risk [Срок оценки: 10 weeks]
• Balance [Срок оценки: 10 weeks]
• Temporal characteristics [Срок оценки: 10 weeks]
• Spatial characteristics [Срок оценки: 10 weeks]
• Physiological [Срок оценки: 10 weeks]
• Digit Span (Wechsler Adult Intelligence Scale [WAIS-IV]) [Срок оценки: 10 weeks]
• Flanker Inhibitory Control and Attention Test [Срок оценки: 10 weeks]

Вторичные конечные точки (2)

• 6 Minute Walk Test [Срок оценки: 10 weeks]
• Dynamic Gait Index (DGI) [Срок оценки: 10 weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Kessler Foundation — West Orange

Идентификаторы

NCT: NCT06719297 · R-1276-24 · 90IFRE0092

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗