Motor-Cognitive Training for Motoric Cognitive Risk Syndrome
ConditionMotoric Cognitive Risk Syndrome
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorUniversity of Kansas Medical Center
About this trial
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:
* Does motor-cognitive training using a virtual reality treadmill improve gait speed? * Does motor-cognitive training using a virtual reality treadmill improve cognitive functions?
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
* Complete 18 sessions (1 hour, 3x/week, 6 weeks) of either virtual reality treadmill training or treadmill training * Complete a pre- and post-training assessment * Wear an activity sensor for seven days prior to the pre-training assessment and for seven days after the post-training assessment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 65
English speaking
Normal cognition (CDR=0)
Meet MCR criteria
Disqualifiers
Major chronic unstable disease or neurological condition (e.g., seizures)
Diagnosed dementia
Active psychiatric conditions
Musculoskeletal conditions that affect walking for more than 2 minutes
Trial design
Design model
Parallel
Treatments tested in this trial
Virtual Reality Treadmill Training
BehavioralThe 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.
Treadmill Training
BehavioralParticipants 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.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Virtual Reality Treadmill TrainingExperimental treatment 1 intervention
Group B: Treadmill TrainingActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Dual-task gait speed
6 minute walk test on a 25-meter walkway while completing auditory oddball task
Time frame
From enrollment to the end of treatment at 6 weeks2
Cognition
Uniform Data Set (UDS) 4.0 global cognition composite score
Time frame
From enrollment to the end of treatment at 6 weeks3
Gait speed
Gait speed on 4-meter walk test (4MWT)
Time frame
From enrollment to the end of treatment at 6 weeks4
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 weeksSecondary outcomes
1
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 weeks2
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 weeks3
Cognitive domain scores
Uniform Data Set 4.0 (UDS) cognitive domain scores
Time frame
From enrollment to the end of treatment at 6 weeks4
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 weeksOther outcomes
1
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 weeks2
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 weeks3
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 weeks4
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 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Kansas Medical Center
Lead sponsor
National Institute on Aging (NIA)
Collaborator
Source ClinicalTrials.gov