Virtual Reality Treadmill for Dementia

(VRTT for MCR Trial)

Overseen By Hannes Devos, PhD

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: University of Kansas Medical Center

Must not be taking: Narcotics, Anxiolytics

Disqualifiers: Dementia, Seizures, Psychiatric conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 18

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if training on a virtual reality treadmill can improve walking speed and brain function in older adults at risk for dementia. Participants will either use a virtual reality treadmill, walking and completing tasks in a simulated environment, or a regular treadmill without virtual tasks. This motor-cognitive training is designed to enhance both physical and cognitive abilities. The trial seeks individuals aged 65 and older with normal thinking skills but at risk for dementia due to walking difficulties. Participants will attend 18 one-hour sessions over six weeks and wear an activity tracker before and after the training. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance the quality of life for older adults.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using sedating drugs like narcotics or anxiolytics that cause sedation.

What prior data suggests that this virtual reality treadmill training is safe for older adults with motoric cognitive risk syndrome?

Studies have shown that virtual reality treadmill training (VRTT) can be safe for older adults. In one study, both regular treadmill training and VRTT improved movement and thinking skills without causing serious side effects. Another study found that VRTT reduced frailty, strengthening the body, with no major safety concerns reported. This suggests that many people can handle VRTT well.

However, any new treatment may carry some risks. It is always best to consult healthcare providers to understand the benefits and risks before joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Virtual Reality Treadmill for Dementia because it offers a unique way to combine physical and cognitive training using virtual reality. Unlike traditional treadmill exercises that only focus on walking speed and distance, this approach immerses participants in a virtual environment where they navigate obstacles and perform cognitive tasks. This dual-action method could enhance both motor and cognitive functions simultaneously, which is not typically addressed by current dementia treatments focusing mainly on medications or physical exercise alone. The potential for improved brain and body coordination makes this an innovative and promising direction in dementia care.

What evidence suggests that virtual reality treadmill training is effective for improving motor and cognitive functions in older adults at risk of dementia?

This trial will compare Virtual Reality Treadmill Training (VRTT) with traditional Treadmill Training (TT). Studies have shown that incorporating virtual reality with treadmill exercises (VRTT) can improve cognitive skills in individuals at risk of dementia. Research suggests that combining treadmill workouts with virtual reality enhances both mental and physical abilities more than using a treadmill alone. One study found that VRTT significantly enhances cognitive skills, particularly those targeted during the training. Additionally, VRTT may slow the progression of memory and cognitive decline. The virtual reality component adds an interactive challenge for the brain, potentially leading to these positive effects. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for English-speaking adults aged 65 or older with normal cognition and motoric cognitive risk syndrome, who can walk for at least 2 minutes. It's not suitable for those with unstable diseases, diagnosed dementia, active psychiatric conditions, severe visual/hearing impairments, or on sedating drugs.

Inclusion Criteria

English speaking

Voluntary consent

Normal cognition (CDR=0)

Exclusion Criteria

Active psychiatric conditions

I cannot walk for more than 2 minutes due to a musculoskeletal condition.

I have severe problems with my vision or hearing.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-training Assessment

Participants complete a pre-training assessment and wear an activity sensor for seven days prior

1 week

Treatment

Participants undergo 18 sessions of either virtual reality treadmill training or treadmill training over six weeks

6 weeks

18 visits (in-person)

Post-training Assessment

Participants complete a post-training assessment and wear an activity sensor for seven days after

1 week

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Motor-Cognitive Training

Trial Overview The study compares two types of training to improve walking speed and thinking skills in older adults at risk of dementia: traditional treadmill training versus virtual reality treadmill training. Participants will undergo 18 sessions over six weeks and have assessments before and after the program.

How Is the Trial Designed?

Group I: Virtual Reality Treadmill Training Experimental Treatment 1 Intervention

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 II: Treadmill Training Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Kansas Medical Center

Lead Sponsor

Trials

527

Recruited

181,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6021455/

Virtual reality-based cognitive-motor training for middle-aged ... The authors conclude that VR (together with computerized cognitive training) is effective in delaying the progression of cognitive impairment (see also [26]).

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07223905

Study Details | NCT07223905 | Motor-Cognitive Training ... 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 ...

3. frontiersin.org frontiersin.org/journals/aging-neuroscience/articles/10.3389/fnagi.2021.753381/full

Motor–Cognitive Treadmill Training With Virtual Reality in ... Our results suggest that a longer TT + VR training leads to greater improvements in cognitive functions especially those directly addressed by ...

4. bmcpsychiatry.biomedcentral.com bmcpsychiatry.biomedcentral.com/articles/10.1186/s12888-019-2180-x

The effectiveness of virtual reality for people with mild ... The aim of this study was to synthesize the effects of VR interventions for people with mild cognitive impairment (MCI) or dementia.

5. sciencedirect.com sciencedirect.com/science/article/pii/S0003999324012620

Effects of a 6-Week Treadmill Training With and Without ... TT with or without virtual reality can reduce frailty levels in pwMS. While both TT and TT+VR had a positive effect on overall frailty, only TT+VR improved ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06727942

Virtual Reality-Infused Treadmill Training on Aging-Related ... This purpose of this study is to design and implement a Virtual Reality-Infused Treadmill Training on Aging-Related Outcomes (V-TARGET) intervention, focusing ...

7. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0276989

Acute effects of virtual reality treadmill training on gait and ... The results indicate that both VRTT and CTT may acutely improve gait and cognition. Therefore, older adults will likely benefit from participating in either ...

8. bmcneurol.biomedcentral.com bmcneurol.biomedcentral.com/articles/10.1186/1471-2377-13-15

V-TIME: a treadmill training program augmented by virtual ... The primary aim is to demonstrate that six weeks of treadmill training augmented by VR (TT+VR) reduces the risk of falls in a relatively large ...