Cycling and Virtual Reality for Multiple Sclerosis
(PACE-MS Trial)
Recruiting in Palo Alto (17 mi)
Overseen byCarly Wender, PhD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Kessler Foundation
Must not be taking: Steroids, Benzodiazepines
Disqualifiers: Neurological disorders, Uncontrolled psychiatric, Pregnancy, others
No Placebo Group
Trial Summary
What is the purpose of this trial?To compare the effects of cycling exercise with different types of virtual reality on processing/thinking speed in persons with multiple sclerosis (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 data supports the effectiveness of the treatment PACE-MS for multiple sclerosis?
Research suggests that both cycling and virtual reality (VR) exercises can improve physical and cognitive abilities in people with multiple sclerosis (MS). VR-based exercises, in particular, have shown to enhance motivation and therapy outcomes, potentially making them more effective than conventional exercises.
12345Is cycling and virtual reality safe for people with multiple sclerosis?
In a study where people with multiple sclerosis participated in a physical activity expedition, some experienced minor medical events, but those with mild disability and no other health issues had no problems. This suggests that physical activity, like cycling, can be safe for some people with MS, but individual health conditions should be considered.
678910How is the PACE-MS treatment different from other treatments for multiple sclerosis?
The PACE-MS treatment is unique because it combines cycling with virtual reality (VR) to enhance physical and cognitive abilities in people with multiple sclerosis. This approach leverages VR to create an engaging and immersive environment, which has been shown to improve outcomes more effectively than conventional exercise alone.
24101112Eligibility Criteria
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.
+1 more
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
+4 more
Trial Timeline
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
Participant Groups
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.
3Treatment groups
Experimental Treatment
Active Control
Group I: Cycling with Visually Stimulating VRExperimental Treatment1 Intervention
Cycling with virtual reality where I only have to look at the environment while I cycle.
Group II: Cycling with Cognitively Stimulating VRExperimental Treatment1 Intervention
Cycling with virtual reality where I have to complete a thinking task while cycling in the virtual environment.
Group III: Cycling AloneActive Control1 Intervention
Cycling alone, with no virtual reality.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Kessler FoundationEast Hanover, NJ
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Who Is Running the Clinical Trial?
Kessler FoundationLead Sponsor
Consortium of Multiple Sclerosis CentersCollaborator
References
Exercise Effects on Multiple Sclerosis Quality of Life and Clinical-Motor Symptoms. [2021]Different therapies can improve clinical and motor symptoms of multiple sclerosis (MS) similarly, but studies comparing the effects of different exercise therapies on clinical and motor outcomes are scant. We compared the effects of exergaming (EXE), balance (BAL), cycling (CYC), proprioceptive neuromuscular facilitation (PNF), and a standard care wait-listed control group (CON) on clinical and motor symptoms and quality of life (QoL) in people with MS (PwMS).
Comparing virtual reality exergaming with conventional exercise in rehabilitation of people with multiple sclerosis: A systematic review. [2023]This systematic review aimed to present the comparison of the impacts of conventional exercise and virtual reality (VR) exergaming on the physical and cognitive abilities of people with multiple sclerosis (PwMS). The literature search was conducted in the EMBASE, PubMed, Scopus, CINAHL, and Cochrane Library databases. Eligible studies were identified by independent reviewers based on the title, abstract and full-texts. Studies were limited to randomized clinical trials published in peer-reviewed journals in English that compared conventional exercise with VR-exergaming for improving the physical and cognitive abilities of PwMS. Selected studies were assessed for their risk of bias and the major findings of the reviewed studies were analyzed descriptively. The search identified 239 articles of which 10 studies met the eligibility criteria. Despite these studies employing strategies to control biases, some risks of bias remain. Various gaming platforms and conventional exercises were used based on the extent of technologies and therapy regimens. The selected studies used measures of physical and cognitive abilities to compare VR-exergaming with conventional exercise. This review suggests positive impacts of both VR-exergaming and conventional exercise in MS rehabilitation. We also found that VR-exergaming generally exceeded conventional exercise for improving physical and cognitive abilities, psychosocial status, and fatigue.
Immersive virtual reality during gait rehabilitation increases walking speed and motivation: a usability evaluation with healthy participants and patients with multiple sclerosis and stroke. [2021]The rehabilitation of gait disorders in patients with multiple sclerosis (MS) and stroke is often based on conventional treadmill training. Virtual reality (VR)-based treadmill training can increase motivation and improve therapy outcomes. The present study evaluated an immersive virtual reality application (using a head-mounted display, HMD) for gait rehabilitation with patients to (1) demonstrate its feasibility and acceptance and to (2) compare its short-term effects to a semi-immersive presentation (using a monitor) and a conventional treadmill training without VR to assess the usability of both systems and estimate the effects on walking speed and motivation.
An Immersive Virtual Kitchen Training System for People with Multiple Sclerosis: A Development and Validation Study. [2023]Rehabilitation via virtual reality (VR) training tools allows repetitive, intensive, and task-specific practice in a controlled and safe environment. Our goal was to develop and validate a novel immersive VR system based on the practice of real-life activities in a kitchen environment in people with multiple sclerosis (pwMS) with upper-limb dysfunction. The novel immersive VR kitchen application includes several tasks, i.e., tidying up the kitchen, preparing a hamburger and soup meal, and dish washing. Following the development phase, the system was tested for an 8-week intervention period on a small sample of pwMS suffering from upper-limb dysfunction. The Suitability Evaluation Questionnaire for VR systems served as the primary outcome. The scores for enjoyment, sense of comfort with the system, feelings of success and control, realism, easy-to-understand instructions, assists in rehabilitation therapy, were between 4.0 and 4.6, indicating a high satisfaction. The scores for eye discomfort, dizziness, nausea, and disorientation during practice were between 2.8 and 1.3, indicating a low-to-moderate interference of the system. The virtual kitchen training system is feasible and safe for upper-limb training in pwMS and paves the way for future RCTs to examine the benefits of the system compared with standard care, thus improving the functionality of the upper limbs in pwMS.
Effectiveness of virtual reality training for balance and gait rehabilitation in people with multiple sclerosis: a systematic review and meta-analysis. [2019]To evaluate the evidence for the use of virtual reality to treat balance and gait impairments in multiple sclerosis rehabilitation.
Impact of a 5-day expedition to machu picchu on persons with multiple sclerosis. [2021]Persons with multiple sclerosis (MS) are less physically active than nondiseased persons and often report low self-efficacy levels. In the context of an awareness project to promote physical activity and participation in MS, we addressed the impact of training for and participation in a unique expedition. Medical events, relapses, and self-reported neurological worsening were followed from 6 months before and up to 4 months afterwards. Validated patient-reported outcome measures were used to assess fatigue, self-efficacy in exercising, walking abilities, and illness perception. Nine participants completed the training, expedition, and observational study. Minor events, relapses, and/or neurological worsening were reported in six participants. The three participants with mild disability and no cardiovascular risk factors or comorbidities were free of medical and neurological events. We found a significant reduction of motor fatigue at last when compared with the first assessment. The reduction tended to be more evident in participants with mild disability (Expanded Disability Status Scale (EDSS)
Free-Living Peak Cadence in Multiple Sclerosis: A New Measure of Real-World Walking? [2023]Physical function and walking performance have become important outcomes in clinical trials and rehabilitation involving persons with multiple sclerosis (MS). However, assessments conducted in controlled settings may not reflect real-world capacity and movement in a natural environment. Peak cadence via accelerometry might represent a novel measure of walking intensity and prolonged natural effort under free-living conditions.
Reactivity in baseline accelerometer data from a physical activity behavioral intervention. [2018]This brief report describes the possibility of reactivity in the baseline assessment of physical activity using accelerometry from two separate randomized controlled trials of a behavior intervention for increasing physical activity in persons with multiple sclerosis (MS).
Lessons learned from clinical trials of exercise and physical activity in people with MS - guidance for improving the quality of future research. [2022]The body of research on exercise and physical activity among persons with multiple sclerosis(MS) has expanded rapidly in quantity, but not necessarily quality, over the past 20+ years. There is evidence for beneficial effects of exercise and physical activity on immune cells and neurotrophic factors, brain structure and function, walking and cognitive performance, fatigue, depression, and pain, and quality of life among persons with MS. Nevertheless, there is heterogeneity in the outcomes of exercise and physical activity, and a recognition of substantial challenges for improving the effectiveness of those behaviors in MS. To move the field forward, members of the National MS Society physical wellness research working-group pooled collective experiences for identifying challenges, logistic complexities, and opportunities for researchers in designing and conducting interventions of exercise and physical activity among persons with MS. We examined the scope of our experiences and identified collective "lessons learned" regarding the behaviors themselves; study design features and stage of research; study setting, safety, and sample selection; and implementation of randomized controlled trials(RCTs) and treatment fidelity. This paper provides a resource that can inform researchers, particularly new investigators or established investigators transitioning into MS, on conducting high-quality RCTs on exercise and physical activity in MS.
Reliability of RT3 accelerometer for measuring mobility in people with multiple sclerosis: pilot study. [2022]This pilot study investigated the test-retest reliability of an RT3 accelerometer (RT3) for measuring motion in people with multiple sclerosis (MS). Ten people with MS (mean age 49 yr; Extended Disability Status Scale mean +/- standard deviation = 3.4 +/- 1.3) and ten nondisabled people (mean age 40 yr) wore the RT3 while they performed three discrete mobility tasks on two occasions separated by 1 week. The intraclass correlation coefficients (ICCs) calculated from the RT3 motion data for the group with MS were 0.64 for the 5-minute walk test (p = 0.01), 0.50 for the timed up and go test (p = 0.05), and 0.76 for the stair-climbing task (p = 0.002). For the control group, these values were 0.65 (p = 0.01), -0.04 (p = 0.54), and 0.39 (p = 0.11), respectively. We found that the RT3 can potentially provide stable data when measuring walking, but a more robust, yet participant-friendly, method of attaching the RT3 is required. Both participant groups demonstrated inconsistencies in motor-task performance, highlighting a potential source of measurement error that would need to be addressed when future studies are designed. Based on the results of the 5-minute walk test in this study, a sample of 53 participants would be required to obtain an ICC value with a 95% confidence interval of width 0.2 using two repeat measurements.
Effects of a virtual reality and treadmill training on gait of subjects with multiple sclerosis: a pilot study. [2022]Gait and cognitive deficits are common in multiple sclerosis (MS) and are negatively affected during dual-task walking. Treadmill (TM) training has been previously used to preserve locomotor activity in MS. Virtual reality (VR) engages the user in cognitive and motor activities simultaneously. A training combining TM and VR has been successfully adopted in several neurological diseases, but not in MS. This study aims at investigating the feasibility of a VR-based TM training program on gait of subjects with MS. Eight persons with relapsing-remitting MS were recruited to participate in a six-week VR-based TM training program. Gait analysis was performed both in single and dual task conditions. Clinical tests were used to assess walking endurance and obstacle negotiation. All the evaluations were performed before, immediately and one month after the training. Gait speed and stride length improved in dual task post-intervention and were retained at follow-up. An improved ability in negotiating obstacles was found across the evaluations. VR-based TM training program is feasible and safe for MS subjects with moderate disabilities and may positively affect gait under complex conditions, such as dual tasking and obstacle negotiation.
An innovative training program based on virtual reality and treadmill: effects on gait of persons with multiple sclerosis. [2022]In this single blind randomized controlled trial, we examined the effect of a virtual reality-based training on gait of people with multiple sclerosis.