Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2025-12-26 @ 2:03 AM
Study NCT ID:
NCT07223905
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-26
First Post:
2025-10-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Motor-Cognitive Training for Motoric Cognitive Risk Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Assessors will be blinded to the group allocation'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'single-blind randomized controlled trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-20', 'studyFirstSubmitDate': '2025-10-28', 'studyFirstSubmitQcDate': '2025-10-31', 'lastUpdatePostDateStruct': {'date': '2025-11-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Real-world physical activity and gait data', 'timeFrame': 'From enrollment to the end of treatment at 6 weeks', 'description': 'Physical activity and gait data collected from activity sensors'}, {'measure': 'Depression', 'timeFrame': 'From enrollment to the end of treatment at 6 weeks', 'description': 'Scores on the Geriatric Depression Scale (GDS): range 0 - 15; higher score is worse'}, {'measure': 'Health-related Quality of life', 'timeFrame': 'From enrollment to the end of treatment at 6 weeks', 'description': 'Scores on Short Form 36 (SF-36): range 0 - 100; higher score is better'}, {'measure': 'Frailty', 'timeFrame': 'From enrollment to the end of treatment at 6 weeks', 'description': 'Scores on the Evaluative Frailty Index for Physical Activity (EFIPA): range 0 - 1; higher score is worse'}, {'measure': 'Falls', 'timeFrame': 'From enrollment to the end of treatment at 6 weeks', 'description': 'Self-report of falls via falls diaries'}, {'measure': 'Resilience', 'timeFrame': 'From enrollment to the end of treatment at 6 weeks', 'description': 'Brief Resilience Scale (BRS): range 6 - 30; higher scores are better'}], 'primaryOutcomes': [{'measure': 'Dual-task gait speed', 'timeFrame': 'From enrollment to the end of treatment at 6 weeks', 'description': '2 trials of 2-minute walking on a 10-meter walkway while completing auditory oddball task'}, {'measure': 'Cognition', 'timeFrame': 'From enrollment to the end of treatment at 6 weeks', 'description': 'Uniform Data Set (UDS) 4.0 global cognition composite score'}, {'measure': 'Gait speed', 'timeFrame': 'From enrollment to the end of treatment at 6 weeks', 'description': 'Gait speed on 4-meter walk test (4MWT)'}, {'measure': 'Cognitive complaints', 'timeFrame': 'From enrollment to the end of treatment at 6 weeks', 'description': 'Self-report of cognitive complaints based on memory item of the Geriatric Depression Scale (GDS): yes - no'}], 'secondaryOutcomes': [{'measure': 'Dual task cost', 'timeFrame': 'From enrollment to the end of treatment at 6 weeks', 'description': 'Motor and cognitive dual task cost defined using ((dual task - single task) / single task) \\* 100'}, {'measure': 'Spatiotemporal gait characteristics', 'timeFrame': 'From enrollment to the end of treatment at 6 weeks', 'description': 'Inertial Motion Units will collect spatiotemporal gait characteristics during single-task and dual-task walking'}, {'measure': 'Cognitive domain scores', 'timeFrame': 'From enrollment to the end of treatment at 6 weeks', 'description': 'Uniform Data Set 4.0 (UDS) cognitive domain scores'}, {'measure': 'P3 event-related potential (ERP)', 'timeFrame': 'From enrollment to the end of treatment at 6 weeks', 'description': 'P3 event-related potential (ERP) extracted from electroencephalography during oddball test'}, {'measure': 'Mitochondrial function', 'timeFrame': 'From enrollment to the end of treatment at 6 weeks', 'description': 'Mitochondrial functional index collected from blood serum'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Motoric Cognitive Risk Syndrome']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to investigate if combined motor-cognitive training can improve motor and cognitive symptoms in older adults with motoric cognitive risk syndrome. The main questions it aims to answer are:\n\n* Does motor-cognitive training using a virtual reality treadmill improve gait speed?\n* Does motor-cognitive training using a virtual reality treadmill improve cognitive functions?\n\nResearchers will compare virtual reality treadmill training with treadmill training to see if virtual reality treadmill training works to improve motor and cognitive functions in older adults at risk of dementia\n\nParticipants will\n\n* Complete 18 sessions (1 hour, 3x/week, 6 weeks) of either virtual reality treadmill training or treadmill training\n* Complete a pre- and post-training assessment\n* Wear an activity sensor for seven days prior to the pre-training assessment and for seven days after the post-training assessment.', 'detailedDescription': 'The objective of this single-blind randomized controlled trial is to compare the effects of combined motor-cognitive training using a virtual reality treadmill with motor training using a conventional treadmill in older adults with Motoric Cognitive Risk (MCR) syndrome. MCR is a geriatric condition characterized by slow gait speed and subjective cognitive complaints. The coexistence of motor and cognitive impairments in individuals with MCR significantly increases their risk of developing dementia. To date, randomized controlled trials investigating active interventions that simultaneously target both motor and cognitive functions remain scarce. This study will examine whether 18 training sessions, delivered over six weeks at a frequency of three 1-hour sessions per week, using a virtual reality treadmill lead to greater improvements in motor and cognitive outcomes compared to conventional treadmill training.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 65\n* English speaking\n* Normal cognition (CDR=0)\n* Meet MCR criteria\n* Voluntary consent\n\nExclusion Criteria:\n\n* Major chronic unstable disease or neurological condition (e.g., seizures)\n* Diagnosed dementia\n* Active psychiatric conditions\n* Musculoskeletal conditions that affect walking for more than 2 minutes\n* Severe visual or hearing impairments\n* Sedating drugs (new use of narcotics or anxiolytics within the past month or chronic use that causes sedation)\n* Currently engaged in other non-pharmacological interventions to improve cognition or walking'}, 'identificationModule': {'nctId': 'NCT07223905', 'acronym': 'VRTT for MCR', 'briefTitle': 'Motor-Cognitive Training for Motoric Cognitive Risk Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'University of Kansas Medical Center'}, 'officialTitle': 'Motor-Cognitive Training for Motoric Cognitive Risk Syndrome', 'orgStudyIdInfo': {'id': '00161860'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Virtual Reality Treadmill Training', 'description': "The virtual reality treadmill training (VRTT) group will complete 18 training sessions over six weeks (three 1-hour sessions per week). Participants will perform prescribed tasks designed to challenge motor, cognitive, and motor-cognitive functions within a VR environment projected onto a screen in front of the treadmill (Fig 1). The VRTT system includes a conventional treadmill with a harness suspension system, camera-based motion capture (Intel RealSense, Santa Clara, CA), and a computer-generated simulation (GaitBetter, Tel Aviv, Israel). The camera tracks the participant's feet movements, which are displayed within the VR environment, allowing participants to see their feet navigating obstacles, pathways, and narrow corridors. Each session will include three walking bouts interspersed with rest breaks, targeting at least 40 minutes of active motor-cognitive training.", 'interventionNames': ['Behavioral: Virtual Reality Treadmill Training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Treadmill Training', 'description': 'Participants in the treadmill training (TT) intervention will follow a traditional TT program without feedback from the VR system. 70 The focus will be on increasing gait speed and distance, with no motor-cognitive training such as obstacle crossing or cognitive tasks while walking.', 'interventionNames': ['Behavioral: Treadmill Training']}], 'interventions': [{'name': 'Virtual Reality Treadmill Training', 'type': 'BEHAVIORAL', 'description': "The Virtual Reality Treadmill Training (VRTT) group will complete 18 training sessions over six weeks (three 1-hour sessions per week). Participants will perform prescribed tasks designed to challenge motor, cognitive, and motor-cognitive functions within a VR environment projected onto a screen in front of the treadmill (Fig 1). The VRTT system includes a conventional treadmill with a harness suspension system, camera-based motion capture (Intel RealSense, Santa Clara, CA), and a computer-generated simulation (GaitBetter, Tel Aviv, Israel). The camera tracks the participant's feet movements, which are displayed within the VR environment, allowing participants to see their feet navigating obstacles, pathways, and narrow corridors. Each session will include three walking bouts interspersed with rest breaks, targeting at least 40 minutes of active motor-cognitive training.", 'armGroupLabels': ['Virtual Reality Treadmill Training']}, {'name': 'Treadmill Training', 'type': 'BEHAVIORAL', 'description': 'Participants in the Treadmill Training (TT) intervention will follow a traditional TT program without feedback from the VR system. 70 The focus will be on increasing gait speed and distance, with no motor-cognitive training such as obstacle crossing or cognitive tasks while walking.', 'armGroupLabels': ['Treadmill Training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'contacts': [{'name': 'Hannes Devos, PhD', 'role': 'CONTACT', 'email': 'hdevos@kumc.edu', 'phone': '913-588-8253'}, {'name': 'Sodiq Fakorede', 'role': 'CONTACT', 'email': 'sfakorede@kumc.edu', 'phone': '913-588-8253'}, {'name': 'Hannes Devos', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Kansas Medical Center', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}], 'centralContacts': [{'name': 'Hannes Devos, PhD', 'role': 'CONTACT', 'email': 'hdevos@kumc.edu', 'phone': '913-588-8253'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Kansas Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}