Motoric Cognitive Risk SyndromeVRTT for MCRNCT07223905
Motor-Cognitive Training for Motoric Cognitive Risk Syndrome
A study testing Virtual Reality Treadmill Training and Treadmill Training in people with Motoric Cognitive Risk Syndrome, run by University of Kansas Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Motoric Cognitive Risk Syndrome
- What is being tested?
- Virtual Reality Treadmill Training and Treadmill Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Mar 2026to 30 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age ≥ 65
- English speaking
- Normal cognition (CDR=0)
- Meet MCR criteria
- Voluntary consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Kansas Medical Center
Kansas City, Kansas, 66160
Hannes Devos, PhD, 913-588-8253, hdevos@kumc.edu
Sodiq Fakorede, 913-588-8253, sfakorede@kumc.edu
About this study
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?
Read more
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.
Read the 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.
- Conditions
- Motoric Cognitive Risk Syndrome
- Being tested
- Virtual Reality Treadmill Training, Treadmill Training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality Treadmill TrainingBehavioural
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 TrainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Treadmill Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dual-task gait speed
6 minute walk test on a 25-meter walkway while completing auditory oddball task
Measured: From enrollment to the end of treatment at 6 weeks
Cognition
Uniform Data Set (UDS) 4.0 global cognition composite score
Measured: From enrollment to the end of treatment at 6 weeks
Gait speed
Gait speed on 4-meter walk test (4MWT)
Measured: 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
Measured: From enrollment to the end of treatment at 6 weeks
Secondary outcomes (5)
Dual task cost
Motor and cognitive dual task cost defined using ((dual task - single task) / single task) * 100
Measured: From enrollment to the end of treatment at 6 weeks
Spatiotemporal gait characteristics
Inertial Motion Units will collect spatiotemporal gait characteristics during single-task and dual-task walking
Measured: From enrollment to the end of treatment at 6 weeks
Cognitive domain scores
Uniform Data Set 4.0 (UDS) cognitive domain scores
Measured: 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
Measured: From enrollment to the end of treatment at 6 weeks
Mitochondrial function
Mitochondrial functional index collected from blood serum
Measured: From enrollment to the end of treatment at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2025
- Study start10 Mar 2026
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Motoric Cognitive Risk SyndromeStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- single-blind randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07223905
- Sponsor's protocol ID
- 00161860
- Acronym
- VRTT for MCR
- Status last verified
- Oct 2026
- First submitted
- 28 Oct 2025
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motor-Cognitive Training for Motoric Cognitive Risk Syndrome
- ClinicalTrials.gov ID
- NCT07223905
- Acronym / sponsor ID
- VRTT for MCR / 00161860
- Conditions
- Motoric Cognitive Risk Syndrome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 10 Mar 2026 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 3 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- single-blind randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Treadmill Training | Experimental | Behavioral: Virtual Reality Treadmill TrainingThe 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 | Active comparator | Behavioral: Treadmill TrainingParticipants 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Age ≥ 65
- English speaking
- Normal cognition (CDR=0)
- Meet MCR criteria
- Voluntary consent
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality Treadmill TrainingThe 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. | Behavioural | Virtual Reality Treadmill Training |
| Treadmill TrainingParticipants 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. | Behavioural | Treadmill Training |
Primary outcome
Dual-task gait speed
Time frame: From enrollment to the end of treatment at 6 weeks
6 minute walk test on a 25-meter walkway while completing auditory oddball task
Cognition
Time frame: From enrollment to the end of treatment at 6 weeks
Uniform Data Set (UDS) 4.0 global cognition composite score
Gait speed
Time frame: From enrollment to the end of treatment at 6 weeks
Gait speed on 4-meter walk test (4MWT)
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
5 secondary outcomes
Dual task cost
Time frame: From enrollment to the end of treatment at 6 weeks
Spatiotemporal gait characteristics
Time frame: From enrollment to the end of treatment at 6 weeks
Cognitive domain scores
Time frame: From enrollment to the end of treatment at 6 weeks
P3 event-related potential (ERP)
Time frame: From enrollment to the end of treatment at 6 weeks
Mitochondrial function
Time frame: From enrollment to the end of treatment at 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Treadmill Training and Treadmill Training in people with Motoric Cognitive Risk Syndrome, run by University of Kansas Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hannes Devos, PhD (913-588-8253, hdevos@kumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dual-task gait speed (time frame: From enrollment to the end of treatment at 6 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.