NCT06719297 · NOT YET RECRUITING
Cognitive Integrated Motor Training (CM) to Improve Gait and Balance and Reduce Falls in Older Adults With Mild Cognitive Impairment
This trial is testing whether a personalized virtual reality and mixed reality training program that combines movement with thinking tasks can improve walking, balance, and cognitive function in older adults with mild cognitive impairment. Researchers will also measure brain activity to understand what is changing. It is a Phase NA trial, meaning it is a direct effectiveness study rather than an early safety or dose-finding phase.
Eligibility criteria
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.
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2024-12-05