Motor-Cognitive Training for Motoric Cognitive Risk Syndrome

NCT ID: NCT07223905

Last Updated: 2025-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-01

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Motoric Cognitive Risk Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

single-blind randomized controlled trial
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Assessors will be blinded to the group allocation

Study Groups

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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.

Group Type EXPERIMENTAL

Virtual Reality Treadmill Training

Intervention Type 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

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.

Group Type ACTIVE_COMPARATOR

Treadmill Training

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Kansas Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status

Countries

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United States

Central Contacts

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Hannes Devos, PhD

Role: CONTACT

913-588-8253

Facility Contacts

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Hannes Devos, PhD

Role: primary

913-588-8253

Sodiq Fakorede

Role: backup

913-588-8253

Other Identifiers

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00161860

Identifier Type: -

Identifier Source: org_study_id

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