Motor-Cognitive Training for Motoric Cognitive Risk Syndrome (VRTT for MCR)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Motoric Cognitive Risk Syndrome
• Intervention / Treatment: Behavioral: Virtual Reality Treadmill Training; Behavioral: Treadmill Training

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hannes Devos, PhD; Phone Number: 913-588-8253; Email: hdevos@kumc.edu

Study Locations

• United States
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center
      • Contact: Hannes Devos, PhD; Phone Number: 913-588-8253; Email: hdevos@kumc.edu
      • Contact: Sodiq Fakorede; Phone Number: 913-588-8253; Email: sfakorede@kumc.edu
      • Principal Investigator: Hannes Devos

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age ≥ 65
• English speaking
• Normal cognition (CDR=0)
• Meet MCR criteria
• Voluntary consent

Exclusion Criteria:

• 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
• Severe visual or hearing impairments
• Sedating drugs (new use of narcotics or anxiolytics within the past month or chronic use that causes sedation)
• Currently engaged in other non-pharmacological interventions to improve cognition or walking

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Virtual Reality 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.	Behavioral: Virtual Reality 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.
Active Comparator: 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dual-task gait speed	2 trials of 2-minute walking on a 10-meter walkway while completing auditory oddball task	From enrollment to the end of treatment at 6 weeks
Cognition	Uniform Data Set (UDS) 4.0 global cognition composite score	From enrollment to the end of treatment at 6 weeks
Gait speed	Gait speed on 4-meter walk test (4MWT)	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	From enrollment to the end of treatment at 6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Spatiotemporal gait characteristics	Inertial Motion Units will collect spatiotemporal gait characteristics during single-task and dual-task walking	From enrollment to the end of treatment at 6 weeks
Cognitive domain scores	Uniform Data Set 4.0 (UDS) cognitive domain scores	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	From enrollment to the end of treatment at 6 weeks
Mitochondrial function	Mitochondrial functional index collected from blood serum	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	From enrollment to the end of treatment at 6 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Real-world physical activity and gait data	Physical activity and gait data collected from activity sensors	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	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	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	From enrollment to the end of treatment at 6 weeks
Falls	Self-report of falls via falls diaries	From enrollment to the end of treatment at 6 weeks
Resilience	Brief Resilience Scale (BRS): range 6 - 30; higher scores are better	From enrollment to the end of treatment at 6 weeks

Collaborators and Investigators

• Sponsor: University of Kansas Medical Center

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: October 28, 2025
• First Submitted That Met QC Criteria: October 31, 2025
• First Posted (Estimated): November 3, 2025

Study Record Updates

• Last Update Posted (Actual): November 26, 2025
• Last Update Submitted That Met QC Criteria: November 20, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 00161860

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No