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Clinical Trials/NCT07223905
NCT07223905
Not yet recruiting
Not Applicable

Motor-Cognitive Training for Motoric Cognitive Risk Syndrome

University of Kansas Medical Center1 site in 1 country10 target enrollmentStarted: January 1, 2026Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
10
Locations
1
Primary Endpoint
Dual-task gait speed

Overview

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.

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

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Masking Description

Assessors will be blinded to the group allocation

Eligibility Criteria

Ages
65 Years to — (Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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

Outcomes

Primary Outcomes

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

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

Secondary Outcomes

  • Mitochondrial function(From enrollment to the end of treatment at 6 weeks)
  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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