An interventional study of Virtual Reality Treadmill Training and Treadmill Training in Motoric Cognitive Risk Syndrome, sponsored by University of Kansas Medical Center. Recruiting at 1 site in United States. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-09-30.
Sponsored by University of Kansas Medical Center · Not applicable, Interventional, and Treatment
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:
Researchers 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
Participants will
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.
University of Kansas Medical Center is the lead sponsor of 483 studies on the registry; 113 are open to participants now.
Of its 38 completed or terminated interventional studies of FDA-regulated products, 24 (63%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Behavioral: Virtual Reality Treadmill Training
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.
Behavioral: Treadmill Training
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.
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.
Dual-task gait speed
2 trials of 2-minute walking on a 10-meter walkway while completing auditory oddball task
Time frame: From enrollment to the end of treatment at 6 weeks
Cognition
Uniform Data Set (UDS) 4.0 global cognition composite score
Time frame: From enrollment to the end of treatment at 6 weeks
Gait speed
Gait speed on 4-meter walk test (4MWT)
Time frame: From enrollment to the end of treatment at 6 weeks
Cognitive complaints
Self-report of cognitive complaints based on memory item of the Geriatric Depression Scale (GDS): yes - no
Time frame: From enrollment to the end of treatment at 6 weeks
Dual task cost
Motor and cognitive dual task cost defined using ((dual task - single task) / single task) \* 100
Time frame: From enrollment to the end of treatment at 6 weeks
Spatiotemporal gait characteristics
Inertial Motion Units will collect spatiotemporal gait characteristics during single-task and dual-task walking
Time frame: From enrollment to the end of treatment at 6 weeks
Cognitive domain scores
Uniform Data Set 4.0 (UDS) cognitive domain scores
Time frame: From enrollment to the end of treatment at 6 weeks
P3 event-related potential (ERP)
P3 event-related potential (ERP) extracted from electroencephalography during oddball test
Time frame: From enrollment to the end of treatment at 6 weeks
Mitochondrial function
Mitochondrial functional index collected from blood serum
Time frame: From enrollment to the end of treatment at 6 weeks
Real-world physical activity and gait data
Physical activity and gait data collected from activity sensors
Time frame: From enrollment to the end of treatment at 6 weeks
Depression
Scores on the Geriatric Depression Scale (GDS): range 0 - 15; higher score is worse
Time frame: From enrollment to the end of treatment at 6 weeks
Health-related Quality of life
Scores on Short Form 36 (SF-36): range 0 - 100; higher score is better
Time frame: From enrollment to the end of treatment at 6 weeks
Frailty
Scores on the Evaluative Frailty Index for Physical Activity (EFIPA): range 0 - 1; higher score is worse
Time frame: From enrollment to the end of treatment at 6 weeks
Falls
Self-report of falls via falls diaries
Time frame: From enrollment to the end of treatment at 6 weeks
Resilience
Brief Resilience Scale (BRS): range 6 - 30; higher scores are better
Time frame: From enrollment to the end of treatment at 6 weeks
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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University of Kansas Medical Center