About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

be low risk for developing a cardiovascular event during vigorous exercise according to ACSM

be at least 18 years of age;•

ASIA level A-D;

wheelchair use for at least 75% of community mobility (non-ambulatory);

Disqualifiers

consistent or activity-exacerbated upper extremity pain of at least 4/10;

angina or myocardial infarction within the last year, or other major barriers to upper-extremity exercise;

inability to elevate arms above 45°,

significant spasticity

Trial design

Design model

Single group

Treatments tested in this trial

virtual reality exercise
Other intervention
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.

Treatment groups

16 Participants

are divided into 1 treatment group

Group A: Preliminary clinical efficacy and feasibility of 12-week home-based VR-Move exercise programExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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)

2

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

3

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

4

• 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)

Secondary outcomes

1

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