Motor-Cognitive Training for Motoric Cognitive Risk Syndrome

NCT07223905 | Not Yet Recruiting

• 1 other identifier: 00161860
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Motoric Cognitive Risk Syndrome

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (5)

• Dual task cost

  From enrollment to the end of treatment at 6 weeks

• Spatiotemporal gait characteristics

  From enrollment to the end of treatment at 6 weeks

• Cognitive domain scores

  From enrollment to the end of treatment at 6 weeks

• P3 event-related potential (ERP)

  From enrollment to the end of treatment at 6 weeks

• Mitochondrial function

  From enrollment to the end of treatment at 6 weeks

Other Outcomes (6)

• Real-world physical activity and gait data

  From enrollment to the end of treatment at 6 weeks

• Depression

  From enrollment to the end of treatment at 6 weeks

• Health-related Quality of life

  From enrollment to the end of treatment at 6 weeks

Study Arms (2)

Virtual Reality Treadmill Training

EXPERIMENTAL

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

Treadmill Training

ACTIVE COMPARATOR

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

Interventions

Virtual Reality Treadmill Training BEHAVIORAL

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.

Virtual Reality Treadmill Training

Treadmill Training BEHAVIORAL

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.

Treadmill Training

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Kansas Medical Center: lead

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Central Study Contacts

Hannes Devos, PhD

CONTACT

913-588-8253; hdevos@kumc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessors will be blinded to the group allocation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: single-blind randomized controlled trial

Study Record Dates

• First Submitted: October 28, 2025
• First Posted: November 3, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 26, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)