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Active, Not Recruiting

NCT Number: NCT07223905

Motor-Cognitive Training for Motoric Cognitive Risk Syndrome

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Motoric Cognitive Risk Syndrome

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Dual-task gait speed

    Time frame: From enrollment to the end of treatment at 6 weeks

    2 trials of 2-minute walking on a 10-meter walkway while completing auditory oddball task

  2. Cognition

    Time frame: From enrollment to the end of treatment at 6 weeks

    Uniform Data Set (UDS) 4.0 global cognition composite score

  3. Gait speed

    Time frame: From enrollment to the end of treatment at 6 weeks

    Gait speed on 4-meter walk test (4MWT)

  4. Cognitive complaints

    Time frame: From enrollment to the end of treatment at 6 weeks

    Self-report of cognitive complaints based on memory item of the Geriatric Depression Scale (GDS): yes - no

Secondary outcomes

  1. Dual task cost

    Time frame: From enrollment to the end of treatment at 6 weeks

    Motor and cognitive dual task cost defined using ((dual task - single task) / single task) * 100

  2. Spatiotemporal gait characteristics

    Time frame: From enrollment to the end of treatment at 6 weeks

    Inertial Motion Units will collect spatiotemporal gait characteristics during single-task and dual-task walking

  3. Cognitive domain scores

    Time frame: From enrollment to the end of treatment at 6 weeks

    Uniform Data Set 4.0 (UDS) cognitive domain scores

  4. P3 event-related potential (ERP)

    Time frame: From enrollment to the end of treatment at 6 weeks

    P3 event-related potential (ERP) extracted from electroencephalography during oddball test

  5. Mitochondrial function

    Time frame: From enrollment to the end of treatment at 6 weeks

    Mitochondrial functional index collected from blood serum

Other outcomes

  1. Real-world physical activity and gait data

    Time frame: From enrollment to the end of treatment at 6 weeks

    Physical activity and gait data collected from activity sensors

  2. Depression

    Time frame: From enrollment to the end of treatment at 6 weeks

    Scores on the Geriatric Depression Scale (GDS): range 0 - 15; higher score is worse

  3. Health-related Quality of life

    Time frame: From enrollment to the end of treatment at 6 weeks

    Scores on Short Form 36 (SF-36): range 0 - 100; higher score is better

  4. Frailty

    Time frame: From enrollment to the end of treatment at 6 weeks

    Scores on the Evaluative Frailty Index for Physical Activity (EFIPA): range 0 - 1; higher score is worse

  5. Falls

    Time frame: From enrollment to the end of treatment at 6 weeks

    Self-report of falls via falls diaries

  6. Resilience

    Time frame: From enrollment to the end of treatment at 6 weeks

    Brief Resilience Scale (BRS): range 6 - 30; higher scores are better

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Registry information

Acronym: VRTT for MCR

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Nov 3, 2025
Registry last updated
Jun 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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