Improving Heart Health in Individuals With SCI Using Home-Based Virtual Gaming

NCT06690372 | Not Yet Recruiting DMC

• 2 other identifiers: SC230078CTA_VirtualRealityHT94252410878
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Spinal Cord Injuries (SCI)

Keywords

spinal cord injury; cardiometabolic risk; virtual reality exercise; physical activity

Outcome Measures

Primary Outcomes (9)

• 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.

  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.

  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.

  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

  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.

  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.

  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.

  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.

  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.

  From beginning of intervention (week 4) through end of intervention (week 16)

Secondary Outcomes (4)

• Blood Pressure

  Enrollment, 4 weeks, 12 weeks and 16 weeks

• Central Adiposity

  Enrollment, 4 weeks, 12 weeks and 16 weeks

• Fasting blood glucose

  Enrollment, 4 weeks, 12 weeks and 16 weeks

• Fasting blood lipid profiles

  Enrollment, 4 weeks, 12 weeks and 16 weeks

Other Outcomes (6)

• Exercise Self Efficacy Scale (ESE)

  Enrollment, 4 weeks, 12 weeks and 16 weeks

• SCI Quality of Life Resilience, SCIQoL_RES

  Enrollment, 4 weeks, 12 weeks and 16 weeks

• SCI Quality of Life Positive Affect and Well-being, PAWB

  Enrollment, 4 weeks, 12 weeks and 16 weeks

Study Arms (1)

Preliminary clinical efficacy and feasibility of 12-week home-based VR-Move exercise program

EXPERIMENTAL

Following baseline (week 0) assessments participants will be instructed to maintain their daily activities as usual for four weeks. Following the 4-week control phase, and the pre-intervention data collection session participants will be provided with instructions on set-up and use of the VR exercise platform, clinical dashboard and mobile app. Participants will be issued a wireless heart rate monitor (Polar Electro Oy, Model 190027141, Kemple, Finland) to wear on their wrist during each exercise session, tracking heart rate. Participants will be asked to use the VR-Move platform independently following system prompts (as with any virtual exercise product). 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 m

Other: virtual reality exercise

Interventions

virtual reality exercise OTHER

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.

Preliminary clinical efficacy and feasibility of 12-week home-based VR-Move exercise program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);
• report low amounts of physical activity as determined by the Physical Activity Scale for Individuals with Physical Disabilities (PASIPD). Participants whose combined scores for item 3 (moderate sport or recreation) and 4 (strenuous sport or recreation) ≤10 MET hours per week, will be considered physically inactive.

You may not qualify if:

• 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
• complete upper extremity impairment.

Sponsors & Collaborators

• Drexel University: lead
• United States Department of Defense: collaborator

Study Sites (1)

Drexel University Health Science Building

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Motor Activity

Interventions

Exergaming

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Behavior

Intervention Hierarchy (Ancestors)

Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Margaret Finley, PhD, PT

CONTACT

410-746-2112; maf378@drexel.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: A repeated measures, single group, crossover design will be used, with 16 participants. Once enrolled, participants will serve as their own control with a 4-week control phase (baseline) followed by participation in the 12-week home-based VR-Move exercise protocol (intervention phase).

Study Record Dates

• First Submitted: November 11, 2024
• First Posted: November 15, 2024
• Study Start: December 1, 2025
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

US (1)