[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06719297":3,"trial-entities:NCT06719297":156,"trial-summary:NCT06719297":160},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":38,"secondary_outcomes":92,"sex":99,"minimum_age":100,"maximum_age":101,"healthy_volunteers":102,"eligibility_criteria":103,"std_ages":129,"locations":131,"central_contacts":148,"overall_officials":151,"references":154,"see_also_links":155},"NCT06719297","R-1276-24","Cognitive Integrated Motor Training (CM) to Improve Gait and Balance and Reduce Falls in Older Adults With Mild Cognitive Impairment","Cognitive Integrated Motor Training to Improve Gait and Balance and Reduce Falls in Older Adults With Mild Cognitive Impairment","NOT_YET_RECRUITING","2027-08-31","2024-12","2024-12-05","2024-12-01","Kessler Foundation","OTHER",true,"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)\u002Fmixed 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.\n\nThe study will evaluate the differences between two intervention groups (n=20 each): 1) personalized cognitive integrated sensorimotor VR\u002FMR 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.",null,[19],"Mild Cognitive Impairment",[21],"older adults, mild cognitive impairment, gait, balance","INTERVENTIONAL","TREATMENT",[25],"NA",{"count":27,"type":28},40,"ESTIMATED",[30,34],{"type":14,"name":31,"description":32,"armGroupLabels":33},"Personalized cognitive-sensorimotor VR\u002FMR training","Thinking task integrated walking and balance training program",[31],{"type":14,"name":35,"description":36,"armGroupLabels":37},"Standard of Care","Standard walking and balance training",[35],[39,43,46,49,52,55,58,61,64,67,70,73,76,79,82,85,88],{"measure":40,"description":41,"timeFrame":42},"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",{"measure":44,"description":45,"timeFrame":42},"10 Meter walk test","Participants will be asked to walk about 12 meters. The time taken to walk 10 meters will be recorded.",{"measure":47,"description":48,"timeFrame":42},"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.",{"measure":50,"description":51,"timeFrame":42},"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.",{"measure":53,"description":54,"timeFrame":42},"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.",{"measure":56,"description":57,"timeFrame":42},"Temporal characteristics","This test assesses deviations in timing of steps during walking.",{"measure":59,"description":60,"timeFrame":42},"Spatial characteristics","This test assesses deviations in steplength during walking.",{"measure":62,"description":63,"timeFrame":42},"Physiological","The participants will wear small sensors on their body to assess the activity of the brain and muscles during walking and balancing tasks.",{"measure":65,"description":66,"timeFrame":42},"Digit Span (Wechsler Adult Intelligence Scale [WAIS-IV])","This test assesses attention and working memory.",{"measure":68,"description":69,"timeFrame":42},"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.",{"measure":71,"description":72,"timeFrame":42},"Symbol Digit Modalities Test (SDMT)","This test assesses processing speed without a motor component",{"measure":74,"description":75,"timeFrame":42},"Paced Auditory Serial Addition Test (PASAT)","This test assesses information processing speed \\& ability and working memory",{"measure":77,"description":78,"timeFrame":42},"Letter-Number Sequencing (WAIS-IV)","This test assesses working memory",{"measure":80,"description":81,"timeFrame":42},"Delis-Kaplan Executive Function System","Selected subtests to assess executive function.",{"measure":83,"description":84,"timeFrame":42},"Community Ambulation","This test quantifies the amount of physical activity in the community using IMU sensors that participants will wear.",{"measure":86,"description":87,"timeFrame":42},"Continuous Performance Task","This test assesses attention.",{"measure":89,"description":90,"timeFrame":91},"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",[93,96],{"measure":94,"description":95,"timeFrame":42},"6 Minute Walk Test","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.",{"measure":97,"description":98,"timeFrame":42},"Dynamic Gait Index (DGI)","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.","ALL","65 Years","85 Years",false,{"inclusion":104,"exclusion":110,"raw_text":128},[105,106,107,108,109],"Between the age of 65 and 85 years for older adults.","Montreal Cognitive Assessment (MOCA), 17 \\\u003C MOCA \\\u003C 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.",[111,112,113,114,115,116,117,118,119,120,121,122,123,124,125,126,127],"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\u002Fs.","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.","Inclusion Criteria:\n\n* Between the age of 65 and 85 years for older adults.\n* Montreal Cognitive Assessment (MOCA), 17 \\\u003C MOCA \\\u003C 24\n* Medical clearance will be obtained from my clinician. If participants physician is unavailable the study team clinician will provide the medical clearance.\n* Adequate cognitive function to give informed consent, understand the training and instructions, use the device and give adequate feedback.\n* Able to stand for 5 minutes.\n\nExclusion Criteria:\n\n* Body weight over 135 kgs.\n* Uncontrolled or unstable seizure disorder.\n* Severe joint contracture or spasticity of the ankle that limits passive range of motion as determined by the team.\n* History of severe cardiac diseases such as myocardial infarction, coronary artery disease, cardiac arrhythmia, or congestive heart failure.\n* Neuromuscular or neurological pathologies (e.g., spinal cord injury, stroke) that will interfere with ambulation.\n* Uncontrolled or unstable orthostatic hypotension.\n* Pre-existing conditions resulting in significant disruption in alignment or function of the lower limb during standing.\n* 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).\n* Diplopia or nystagmus.\n* Walking speed from 10MWT \\>0.8m\u002Fs.\n\nMRI specific exclusion criteria:\n\n* Medications such as: steroids, benzodiazepines, and neuroleptics. The study doctor will review the medications with the participant.\n* 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.\n* non MRI compatible metal in any part of the body.\n* Medical clearance from a physician that it is medically unsafe to receive regular MRI.\n* Engage in the professions of painting or welding or other occupation that prevents me from getting a regular MRI.\n* claustrophobia (fear of enclosed spaces).\n* History of schizophrenia or bipolar disorder.",[130],"OLDER_ADULT",[132],{"facility":13,"city":133,"state":134,"zip":135,"country":136,"contacts":137,"geoPoint":145},"West Orange","New Jersey","07052","United States",[138,143],{"name":139,"role":140,"phone":141,"email":142},"Kiran Karunakaran, PhD","CONTACT","551-358-3672","kirankarun@gmail.com",{"name":139,"role":144},"PRINCIPAL_INVESTIGATOR",{"lat":146,"lon":147},40.79871,-74.23904,[149],{"name":139,"role":140,"phone":150,"email":142},"5513583672",[152],{"name":153,"affiliation":13,"role":144},"Kiran Karunakaran",[],[],{"nct_id":4,"conditions":157,"biomarkers":159},[158],"Mild cognitive disorder",[],{"nct_id":4,"found":15,"summary":161,"prompt_version":171},{"design":162,"status":163,"heading":164,"summary":165,"follow_up":166,"word_count":167,"commitments":168,"compensation":169,"drugs_mentioned":170},"This study is an interventional study planning to enroll 40 participants. It compares two types of training: Personalized cognitive-sensorimotor VR\u002FMR training and Standard of Care.","completed","Cognitive Integrated Motor Training for Mild Cognitive Impairment","This study is testing a new type of training called Personalized cognitive-sensorimotor VR\u002FMR training. This training combines thinking tasks with walking and balance exercises using virtual or mixed reality. It's designed for older adults (ages 65-85) who have mild cognitive impairment (problems with memory or thinking). The goal is to see if this training can improve walking and balance, reduce falls, and also affect thinking ability and brain activity. Researchers will compare this new training to standard walking and balance training. They will measure improvements in walking and balance after 10 weeks. The study plans to enroll 40 participants, but its current status is unclear.","Participants' walking and balance will be assessed at 10 weeks after the start of the training.",105,"Participants will receive either Personalized cognitive-sensorimotor VR\u002FMR training or standard walking and balance training. Walking and balance will be measured at 10 weeks.","Not stated in the trial record.",[31],"v2"]