What is the ultimate applicability of the research? Individuals with SCI face several challenges when trying to engage in exercise following injury. Barriers to engagement include cost, transportation, and lack of SCI accessible resources. At the same time, individuals with SCI are at risk of developing negative health consequences (e.g., cardiovascular disease) associated with physical inactivity. A critical need exists to improve relevant, accessible, and sustainable home-based exercise interventions for individuals with SCI to lower the risk of developing secondary comorbid diseases from physical inactivity and to promote wellness. This research will investigate a fun and novel in-home virtual reality system aimed toward improving physical fitness of individuals SCI with the ultimate goal of improving physical, emotional, and psychosocial quality of life. Virtual reality gaming has been used for a long time to improve physical fitness, but there have yet to be virtual reality games designed specifically for individuals with SCI. The explicit aim of this research is therefore to develop a therapeutic technology that will be widely accessible to individuals with SCI. What persons with SCI and/or their caregivers will it help, and how will it help them? We aim to provide a readily available exercise platform for individuals with SCI, across a spectrum of physical function. Research has shown that individuals with SCI are particularly prone to be physically inactive. The consequences of physical inactivity have been well documented and include negative outcomes in physical, psychological, and social health with reduced quality of life. For the current study, we will refine our existing virtual reality exercise platform, VR-Move with a focus on non ambulatory individuals with bilaterally preserved C6 function. Our focus on using the exercise platform for this cohort of the SCI population is meant to provide a basis for developing and catering to the platform for higher levels of SCI injury (higher quadriplegic). From our previous work with virtual reality interventions in SCI, we recognize that this product can be widely used by individuals across the age spectrum independently of their home environment. What are the potential clinical applications, benefits, and risks? The proposed virtual reality exercise platform, VR-Move, is intended to provide one of the few accessible exercise modalities designed specifically for individuals with SCI and is readily adaptable across the clinical spectrum - including clinic and self-guided home use. There are no known risks associated with this research. How will the pilot clinical trial advance the research findings along the translational spectrum? This project aims to refine and assess timely therapeutic technology with the specific intention of translating study findings into a clinically validated, widely accessible health product that can be deployed and implemented within the home. The project likewise demonstrates collaboration between academia, industry (a veteran-owned business), and veteran SCI communities. Project completion will offer initial validation of a novel health promoting modality (i.e., virtual reality exercise) informed by individuals living with SCI and experts in SCI to be relevant and responsive to specific health/exercise needs of persons living with SCI. Larger clinical trial testing will subsequently inform product commercialization and dissemination. The resulting platform, developed for unattended in-home use, is expected to make a meaningful contribution to SCI health and physical fitness, accessibility, and quality of life. What is the projected time it may take to achieve a person-related outcome? The team is purposefully refining the existing exercise platform, VR-Move, so that it can be easily implemented within people's homes or in clinic settings. Pending findings from the pilot clinical study, this exercise platform would be available immediately to individuals with SCI What are the likely contributions of the proposed research project to advancing the field of SCI research, patient care, and/or quality of life? The proposed study may make significant contributions across several areas. First, it will facilitate fruitful clinical data and basic lines of scientific inquiry regarding the application of the physical activity paradigm. The study will also increase our knowledge regarding the importance of consumer advocate-driven research for individuals with SCI. Second, low-activity following SCI is consistently associated with reduced quality of life among individuals with SCI and their families; access to an inexpensive portable intervention will therefore significantly improve quality of life among those affected by low-activity SCI.
Overview. Cardiovascular diseases (coronary heart disease, myocardial infarction, stroke) have emerged as leading sources of illness and death for persons with spinal cord injury (SCI). Cardiometabolic disease/syndrome (CMD) is a central risk factor for both cardiovascular disease and diabetes mellitus, and encompasses a cluster of risk factors including hypertension, dyslipidemia, elevated glucose profiles, and central adiposity. In comparison to the general populations, individuals with SCI are more likely to develop CVD and are more likely to have cardiovascular disease and diabetes mellitus. The prevalence of CMD in the SCI population ranges from 33%5 and 63%, and one study found that nearly 58% of Veterans with SCI presented with CMD. Physical inactivity is associated with multiple components of CMD, including obesity, insulin resistance, hypertension, and dyslipidemia. However, while moderate intensity exercise is supported as a powerful tool against CMD over half of individuals living with SCI report no regular physical activity or exercise. Individuals with SCI are nearly 1.5 times more likely to lead sedentary lives than the general population and demonstrate significantly lower physical activity levels compared to individuals with other chronic diseases.10 Critically, everyday activities are not enough to maintain cardiovascular fitness in people with SCI, necessitating targeted exercise interventions. This "physical activity participation gap" presents a significant health crisis for individuals living with SCI and can initiate and exacerbate secondary conditions while dampening psychological well-being and quality of life (QoL). Exercise is an effective non-pharmacologic intervention to improve cardiometabolic risk factors, reduce risk for chronic and secondary conditions, and enhance psychosocial well-being. However, various barriers, such as accessibility, transportation, costs, and motivation, hinder exercise participation for those with SCI, underscoring the urgent need to provide better access to exercise experiences for this population. Virtual reality (VR) gaming has become increasingly integrated into interventions targeting physical, neurocognitive, and psychological conditions, concurrently addressing issues like access, cost, and motivation. VR-mediated exercise interventions report strong adherence, reduced perception of effort and fatigue, and increased enjoyment of exercise participation. A global survey by the American College of Sports Medicine concluded that remote, home-based exercise, including virtual exercise, is the top fitness trend following the COVID-19 pandemic. However, while the likely benefit of home-based virtual exercise platforms for mobility impaired users is acknowledged all interventions to date have employed systems designed for able-bodied individuals. Remarkably, there has yet to be a virtual exercise platform specifically informed by input from, and exercise needs of, individuals with SCI. Further, while laboratory studies have established the potency of virtual exercise for individuals with SCI, there has yet to be a prospective study of the feasibility or cardiometabolic efficacy of a home-based virtual exercise intervention in this population. The current study assembles expertise in SCI physical health, home-based virtual reality intervention, and Lived Experience to address the abovementioned gaps by examining the feasibility and prospective efficacy of the low-cost, immersive, interactive VR exercise platform - VR-Move, deployable for self-directed use within individual homes. The project team has substantial experience and strong preliminary data supporting development and deployment of home-based immersive VR physical activity interventions for individuals with SCI. Study design is supported by a user-centered development approach (community-based participatory research) preliminary data, and a home-based technology paradigm successfully implemented by the current research team in multiple ongoing longitudinal studies with persons with SCI. The proposed study represents an important, sustainable step in promoting cardiometabolic health among people with SCI. This proposal has integrated design elements suggested during the previous review cycle; centrally, the investigators have modified our clinical trial design with direct input from our biostatistical team to be a crossover design with a 4-week baseline control phase followed by a longer intervention phase of 12-weeks. The investigators will obtain repeated measurements at baseline (0-week), pre-intervention (4-weeks), mid-intervention (10-weeks), and post-intervention (16-weeks) which are indeed critical to understanding the longer-term impact of the intervention. The investigators have also clarified VR refinement procedures and the place of the current intervention in the larger VR pain-intervention literature. The investigators believe that these and other changes, as well as our new exciting preliminary findings, further serve to demonstrate that this novel platform has potential to meaningfully impact the health and quality of life in individuals with SCI.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
16
Over the 12-weeks, participants will be instructed to exercise with the VR-Move 3x/week for 30 minutes for 12-weeks total, with modules presented in a prescribed weekly sequence to provide novel and re-enforcement of modules, while ensuring all modules are performed. Further, participants will be provided the opportunity of a 30 minute "free-play" of module of choice once a module has been introduced.
Drexel University Health Science Building
Philadelphia, Pennsylvania, United States
aerobic capacity
Participants will perform a Price and Campbell upper body ergometer test, to estimate cardiorespiratory exercise capacity. The Price and Campbell upper body ergometer test is a multistage cardiorespiratory measure that begins with an initial 2-minute warm-up period of zero-Watt (W) resistance on an upper body ergometer. Following the initial warm-up period, 30 W of resistance will be applied at a crank rate of 60 rpm for 2 minutes, representing stage one of the test. All subsequent stages are progressed incrementally in 30 W intervals at 60 rpm at 2-minute intervals until volitional exhaustion. Peak cardiorespiratory capacity (VO2peak) will be measured in ml/kg body weight.
Time frame: Enrollment to the end of the 12 week-intervention (16 weeks total)
Brief Pain Inventory
The Brief Pain Inventory - Short Form (BPI-sf) is a 9-item self-administered questionnaire used to evaluate the domains of severity and pain interference. Worst, least, average, and current pain intensity and rate the degree that pain interferes with general activity, mood, walking ability, normal work, relations with other persons, sleep, and enjoyment of life on a 10-point scale. A 2-point change in worst pain is considered clinically relevant.
Time frame: Week 10 and week 16
Patient Health Questionnaire-9 (PHQ-9)
The PHQ-9 is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression. The nine items are rated based on frequency of occurrence in the past two weeks "not at all" (0) to "everyday" (3) and summed. Total scores of 5, 10, 15, and 20 represent cut-points for mild, moderate, moderately severe and severe depression, respectively.
Time frame: Week 10 and week 16
• Treatment Evaluation Inventory-short form (TEI)
The TEI short form is a 9-item acceptability rating scale. Each statement is rated on a five-point Likert-type scale (1= Strongly Disagree to 5= Strongly Agree). Participants answer statements regarding how reasonable the intervention will be, how likely they would implement the intervention, and how effective they believed the intervention to be
Time frame: End of intervention (Week 16)
Usefulness, Satisfaction, and Ease of Use Questionnaire (USE)
The USE measures the subjective usability of a product or service. It is a 30-item survey that examines four dimensions of usability: usefulness, ease of use, ease of learning, and satisfaction. The USE questionnaire uses 27 questions with the Likert scale (1 = strongly disagree to 7 - strongly agree), with users answering questions split into 4 domains: Usefulness (8 items, score 8-56), Ease of Use (11 items, score 11-77), Ease of Learning (4 items, score 4-27) and Satisfaction (7 items, score 7-49). Item scores will be converted to a 0-100 scale with domains averaged for a total "utility" score. The positive limit of acceptable usability of the system will be defined as 50.
Time frame: End of intervention (Week 16)
Simulator Sickness Questionnaire (SSQ)
The most common reported measure of cybersickness symptoms is the Simulator Sickness Questionnaire (SSQ). The SSQ was developed to measure sickness in the context of simulation and was derived from a measure of motion sickness. Sixteen items scored 0 (none) to 3 (severe) are totaled for an overall sickness rating. Symptom severity are classified by scores such that \<5 = negligible symptoms, 5-10 = minimal symptoms, 10-15 = significant symptoms with 15-20 symptoms of concern and \>20 a "bad intervention.
Time frame: End of intervention (Week 16)
Numeric rating scale (NRS_Pain) Pain
Participants will rate pain, on a 0-10 Likert scale (0 = none; 10=extreme) at beginning and end of each VR engagement (captured within the system with real-time communication to study team). Within session changes in pain, mood and nausea will be obtained during the trial. A change in pain of \>30% from baseline or 2-point decrement in mood/increase in nausea will facilitate team contact and consultation with the study physician, as needed.
Time frame: From beginning of intervention (week 4) through end of intervention (week 16)
Numeric Rating Scale (NRS-Mood)
Participants will rate mood , on a 0-10 Likert scale (0 = none; 10=extreme) at beginning and end of each VR engagement (captured within the system with real-time communication to study team). Within session changes in pain, mood and nausea will be obtained during the trial. A change in pain of \>30% from baseline or 2-point decrement in mood/increase in nausea will facilitate team contact and consultation with the study physician, as needed.
Time frame: From beginning of intervention (week 4) through end of intervention (week 16)
Numeric Rating Scale Nausea (NRS_Neausea)
Participants will rate nausea, on a 0-10 Likert scale (0 = none; 10=extreme) at beginning and end of each VR engagement (captured within the system with real-time communication to study team). Within session changes in pain, mood and nausea will be obtained during the trial. A change in pain of \>30% from baseline or 2-point decrement in mood/increase in nausea will facilitate team contact and consultation with the study physician, as needed.
Time frame: From beginning of intervention (week 4) through end of intervention (week 16)
Blood Pressure
Resting systolic and diastolic pressure will be measured with an Omron automated blood pressure monitor (Model BP786, Omron Healthcare, Inc., Miami, FL).
Time frame: Enrollment, 4 weeks, 12 weeks and 16 weeks
Central Adiposity
Waist and hip circumference will be measured with a Gulick tape measure (Model 67020, FitnessMart, Gays Mills, WI)-reported in cm.
Time frame: Enrollment, 4 weeks, 12 weeks and 16 weeks
Fasting blood glucose
Fasting blood glucose will be measured with an Abbott Cholestech LDX Finger stick System (Abbott, Chicago, IL). Only certified personnel will perform the finger stick procedures. Because the nature of the physical blood specimens to be collected for the proposed project are routine point of care finger sticks, we will not need to store the blood data for longer than seven (7) to ten (10) minutes. Immediately after the finger stick is collected, the blood will be placed into the Alere Cholestech LDX analyzer, which will then analyze and provide the blood glucose values for the participant within the 10-min timeframe.
Time frame: Enrollment, 4 weeks, 12 weeks and 16 weeks
Fasting blood lipid profiles
Fasting blood lipid profiles will be measured with an Abbott Cholestech LDX Finger stick System (Abbott, Chicago, IL). Because the nature of the physical blood specimens to be collected for the proposed project are routine point of care finger sticks, we will not need to store the blood data for longer than seven (7) to ten (10) minutes. Immediately after the finger stick is collected, the blood will be placed into the Alere Cholestech LDX analyzer, which will then analyze and provide the lipid values for the participant within the 10-min timeframe.
Time frame: Enrollment, 4 weeks, 12 weeks and 16 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.