Cycling and Virtual Reality for Multiple Sclerosis

(PACE-MS Trial)

Overseen By Carly Wender, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Kessler Foundation

Must not be taking: Steroids, Benzodiazepines

Disqualifiers: Neurological disorders, Uncontrolled psychiatric, Pregnancy, others

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

Compensation: Varies

Number of Visits: 3

Duration: 3 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how cycling with and without virtual reality affects thinking speed in individuals with multiple sclerosis (MS). Participants will either cycle alone, cycle while engaging with a virtual reality task, or cycle with a visual virtual reality experience. The goal is to determine which method best aids mental processing. Known as PACE-MS, this trial seeks individuals who have MS, speak English, have mild-to-moderate mobility issues, have been free of relapses and steroids for the past 30 days, and are not currently regular cyclists.

As an unphased study, this trial provides a unique opportunity to contribute to innovative research that could enhance mental processing for those with MS.

Will I have to stop taking my current medications?

The trial requires that you do not use medications that may impact cognition, such as steroids or benzodiazepines. If you are taking these, you may need to stop before participating.

What prior data suggests that these cycling and virtual reality methods are safe for people with multiple sclerosis?

Research shows that both cycling and virtual reality (VR) are generally safe for people with multiple sclerosis (MS). Studies have found that immersive VR is safe, with most people experiencing no major problems. However, some might feel cybersickness, similar to motion sickness.

When cycling with VR that includes cognitive tasks, people with MS find it beneficial for rehabilitation. This type of VR requires thinking while cycling, and many find it fun and engaging.

Cycling with VR that simply displays a virtual environment is also safe and feasible. It can make exercise more enjoyable and help people exercise longer.

In both cases, VR offers a safe and enjoyable way to increase physical activity and improve cognitive skills in people with MS. As always, individuals should consider their health and consult their doctor before starting new exercises. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using cycling combined with virtual reality (VR) for multiple sclerosis (MS) because it offers a unique way to engage both the body and the mind, which is different from traditional drug therapies like interferons and glatiramer acetate. The approach combines physical exercise with either cognitively or visually stimulating VR, potentially enhancing cognitive functions while improving physical fitness. This dual-action strategy might not only help with mobility but also boost mental agility, offering a comprehensive benefit that standard MS treatments don't typically address. By integrating VR, the treatments aim to make exercise more engaging and possibly more effective, which could lead to improved outcomes for people with MS.

What evidence suggests that this trial's treatments could be effective for multiple sclerosis?

Studies have shown that both cycling and virtual reality (VR) can enhance physical and mental abilities in people with multiple sclerosis (MS). This trial will compare different approaches: one group will engage in cycling alone, while others will participate in cycling with either cognitively stimulating VR or visually stimulating VR. Research indicates that VR might enhance traditional exercise and cognitive training for those with MS. Specifically, VR-based therapy reduced fatigue more effectively than standard treatments. Another study found that VR improved balance and lessened the fear of falling. Overall, these findings suggest that combining VR with cycling might improve thinking speed and other skills in people with MS. ^{1 2 6 7 8}

Who Is on the Research Team?

Carly Wender, PhD

Principal Investigator

Kessler Foundation

Are You a Good Fit for This Trial?

This trial is for English-speaking individuals with a confirmed MS diagnosis by a neurologist, who have been free of relapses and steroids for at least 30 days, and report moderate mobility disability. It excludes those with other neurological disorders or uncontrolled psychiatric conditions, contraindications to exercise, cognition-impacting medications use (like steroids), current pregnancy, severe cognitive impairment, high motion sickness likelihood or regular cyclists.

Inclusion Criteria

I have been diagnosed with MS by a neurologist.

I haven't had a relapse or taken steroids in the last 30 days.

I have some difficulty moving around on my own.

Exclusion Criteria

Have contraindications to exercise, based on the Physical Activity Readiness Questionnaire (PAR-Q)

I am taking medication that could affect my thinking or memory.

Currently pregnant

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants complete three cycling conditions: cycling alone, cycling with cognitively stimulating VR, and cycling with visually stimulating VR, one per week.

3 weeks

3 visits (in-person)

Follow-up

Participants are monitored for processing speed improvements after each cycling session.

1 week

What Are the Treatments Tested in This Trial?

Interventions

• PACE-MS

Trial Overview

The PACE-MS trial aims to compare the effects on processing/thinking speed in people with MS when they participate in cycling exercises combined with different types of virtual reality experiences.

How Is the Trial Designed?

Group I: Cycling with Visually Stimulating VR Experimental Treatment 1 Intervention

Cycling with virtual reality where I only have to look at the environment while I cycle.

Group II: Cycling with Cognitively Stimulating VR Experimental Treatment 1 Intervention

Cycling with virtual reality where I have to complete a thinking task while cycling in the virtual environment.

Group III: Cycling Alone Active Control 1 Intervention

Cycling alone, with no virtual reality.

Who Is Running the Clinical Trial?

Kessler Foundation

Lead Sponsor

Trials

190

Recruited

11,300+

Consortium of Multiple Sclerosis Centers

Collaborator

Trials

9

Recruited

50,200+

Published Research Related to This Trial

In a study involving 25 individuals with multiple sclerosis, virtual reality-based treadmill training significantly improved gait parameters, including hip range of motion and hip-generated power, compared to traditional treadmill training.

Both training methods enhanced walking endurance and speed, but the virtual reality group showed additional benefits in balance and greater improvements in specific gait measures, highlighting its potential as an effective rehabilitation tool for gait deficits in multiple sclerosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An innovative training program based on virtual reality and treadmill: effects on gait of persons with multiple sclerosis. Peruzzi, A., Zarbo, IR., Cereatti, A., et al.[2022]

Individuals with multiple sclerosis (MS) showed significantly lower physical function and walking performance compared to healthy controls, as evidenced by lower peak cadence and fewer purposeful steps during daily activities.

Peak cadence, measured through accelerometry, is strongly associated with walking performance in MS patients, suggesting it could be a valuable metric for assessing real-world walking ability and the impact of disability on mobility.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Free-Living Peak Cadence in Multiple Sclerosis: A New Measure of Real-World Walking? Zheng, P., Jeng, B., Huynh, TLT., et al.[2023]

A novel immersive virtual reality (VR) kitchen application was developed and tested over an 8-week period on people with multiple sclerosis (pwMS) who have upper-limb dysfunction, showing high satisfaction scores (4.0 to 4.6) for enjoyment and effectiveness in rehabilitation.

The system demonstrated low-to-moderate levels of discomfort (scores between 2.8 and 1.3) during use, indicating it is a safe and feasible option for upper-limb training, setting the stage for future randomized controlled trials to assess its benefits compared to standard care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Immersive Virtual Kitchen Training System for People with Multiple Sclerosis: A Development and Validation Study. Pau, M., Cocco, E., Arippa, F., et al.[2023]

In two randomized controlled trials involving 38 participants with multiple sclerosis, a significant increase in physical activity was observed from baseline to the first week of a behavioral intervention, suggesting a reactivity effect in the initial assessment.

Study 1 showed an increase of 1,822 steps per day (moderate effect size), while Study 2 showed an even larger increase of 2,338 steps per day (large effect size), indicating that participants may have altered their activity levels upon awareness of being monitored.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reactivity in baseline accelerometer data from a physical activity behavioral intervention. Motl, RW., McAuley, E., Dlugonski, D.[2018]

A systematic review of 10 randomized clinical trials found that both conventional exercise and virtual reality (VR) exergaming positively impact the physical and cognitive abilities of people with multiple sclerosis (PwMS).

VR exergaming was generally more effective than conventional exercise in enhancing physical and cognitive abilities, improving psychosocial status, and reducing fatigue in PwMS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing virtual reality exergaming with conventional exercise in rehabilitation of people with multiple sclerosis: A systematic review. Moeinzadeh, AM., Calder, A., Petersen, C., et al.[2023]

Exercise and physical activity have been shown to provide various benefits for individuals with multiple sclerosis (MS), including improvements in immune function, brain health, walking ability, cognitive performance, fatigue, depression, pain, and overall quality of life.

Despite the positive effects, there is significant variability in the outcomes of exercise interventions for MS, highlighting the need for better-designed studies and a focus on challenges in implementing effective exercise programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lessons learned from clinical trials of exercise and physical activity in people with MS - guidance for improving the quality of future research. Motl, RW., Fernhall, B., McCully, KK., et al.[2022]

A six-week virtual reality-based treadmill training program for eight individuals with relapsing-remitting multiple sclerosis showed significant improvements in gait speed and stride length during dual-task walking, which were maintained one month after the intervention.

The training also enhanced the participants' ability to negotiate obstacles, indicating that this combined approach is both feasible and safe for individuals with moderate disabilities in MS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a virtual reality and treadmill training on gait of subjects with multiple sclerosis: a pilot study. Peruzzi, A., Cereatti, A., Della Croce, U., et al.[2022]

A study involving 68 people with multiple sclerosis showed that exergaming (EXE), balance training (BAL), and cycling (CYC) significantly improved clinical and motor symptoms, with EXE being particularly effective in enhancing gait and balance.

Exergaming also led to improvements in quality of life and walking capacity, indicating it may be a superior exercise option for reducing mobility limitations in individuals with multiple sclerosis compared to other therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise Effects on Multiple Sclerosis Quality of Life and Clinical-Motor Symptoms. Tollár, J., Nagy, F., Tóth, BE., et al.[2021]

Virtual reality balance training significantly improves postural control in individuals with multiple sclerosis compared to no intervention, based on a meta-analysis of 11 studies involving 466 participants.

However, when compared to conventional training methods, virtual reality did not show a significant advantage, suggesting it may be at least as effective as traditional approaches for rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of virtual reality training for balance and gait rehabilitation in people with multiple sclerosis: a systematic review and meta-analysis. Casuso-Holgado, MJ., Martín-Valero, R., Carazo, AF., et al.[2019]

The RT3 accelerometer demonstrated moderate to good test-retest reliability for measuring motion in people with multiple sclerosis, particularly showing strong reliability in the stair-climbing task (ICC = 0.76) and the 5-minute walk test (ICC = 0.64).

Inconsistencies in motor-task performance among both participants with MS and nondisabled individuals suggest that measurement errors may occur, indicating the need for improved methods of attaching the RT3 and careful study design in future research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reliability of RT3 accelerometer for measuring mobility in people with multiple sclerosis: pilot study. Hale, L., Williams, K., Ashton, C., et al.[2022]

Immersive virtual reality (VR) training using a head-mounted display (HMD) significantly improved walking speed in patients with multiple sclerosis and stroke compared to conventional treadmill training and semi-immersive VR, indicating its potential effectiveness for gait rehabilitation.

Participants reported higher motivation and preference for the HMD-based training, with no adverse effects like simulator sickness, suggesting that immersive VR could enhance therapy outcomes and patient engagement in rehabilitation programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immersive virtual reality during gait rehabilitation increases walking speed and motivation: a usability evaluation with healthy participants and patients with multiple sclerosis and stroke. Winter, C., Kern, F., Gall, D., et al.[2021]

Training for and participating in a unique expedition led to a significant reduction in motor fatigue among participants with multiple sclerosis, particularly those with mild disability, indicating potential benefits of physical activity in this population.

Despite some minor medical events reported, no major adverse events occurred, suggesting that the expedition was safe for participants with MS, especially those without cardiovascular risk factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of a 5-day expedition to machu picchu on persons with multiple sclerosis. D'hooghe, MB., Feys, P., Deltour, S., et al.[2021]

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