Virtual Reality Exercise for Spinal Cord Injury

Overseen By Margaret Finley, PhD, PT

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Drexel University

Disqualifiers: Upper extremity pain, Angina, Spasticity, others

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

Compensation: Varies

Number of Visits: 4

16 Participants Needed

Trial Summary

What is the purpose of 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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

What data supports the effectiveness of the treatment Virtual Reality Exercise for Spinal Cord Injury?

Research shows that virtual reality exercise can significantly improve sitting and standing balance in people with spinal cord injuries. It also enhances lower limb strength and functional mobility, suggesting it is a promising rehabilitation tool. ^{1 2 3 4 5}

Is virtual reality exercise safe for people with spinal cord injury?

Research on virtual reality exercise for spinal cord injury shows it is generally safe, with studies reporting improvements in balance and mobility without significant safety concerns. However, more studies are needed to confirm these findings. ^{1 2 3 4 6}

How does virtual reality exercise differ from other treatments for spinal cord injury?

Virtual reality exercise is unique because it uses immersive technology to create engaging and motivating rehabilitation scenarios, which can be done at home and may improve balance, muscle strength, and mobility in spinal cord injury patients. Unlike traditional therapies, it combines action observation and execution, providing a novel way to enhance rehabilitation outcomes. ^{1 2 3 4 7}

Eligibility Criteria

This trial is for individuals with Spinal Cord Injury (SCI), specifically those who are non-ambulatory but have preserved C6 function. It's designed to help them exercise at home using a virtual reality system called VR-Move, which aims to improve their physical fitness and overall quality of life.

Inclusion Criteria

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

I am 18 years old or older.

ASIA level A-D

Exclusion Criteria

I cannot use my arms fully.

I haven't had a heart attack or severe chest pain in the last year.

I experience constant or exercise-worsened arm pain rated at least 4 out of 10.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Control

Participants maintain their daily activities as usual for four weeks

4 weeks

1 visit (in-person) for baseline assessment

Intervention

Participants use the VR-Move platform independently for 12 weeks, exercising 3 times per week for 30 minutes

12 weeks

3 visits (virtual) for data collection at weeks 4, 10, and 16

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Virtual Reality Exercise

Trial Overview The study tests the VR-Move platform, a home-based virtual reality exercise program tailored for people with SCI. The goal is to see if it can be an effective way to increase physical activity and enhance health outcomes without the barriers of cost or transportation.

Participant Groups

Group I: Preliminary clinical efficacy and feasibility of 12-week home-based VR-Move exercise program Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Drexel University

Lead Sponsor

Trials

160

Recruited

48,600+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Findings from Research

A study involving 12 subjects with incomplete spinal cord injury showed that a home-based virtual reality training system significantly improved lower limb muscle strength, balance, and functional mobility after 4 weeks of training.

Participants reported high motivation and positive changes, with functional mobility improvements lasting for at least 2-3 months after the training, indicating the potential of VR as an effective neurorehabilitation tool.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home-Based Virtual Reality-Augmented Training Improves Lower Limb Muscle Strength, Balance, and Functional Mobility following Chronic Incomplete Spinal Cord Injury. Villiger, M., Liviero, J., Awai, L., et al.[2022]

A study involving 20 patients with spinal cord injury showed that combining virtual reality (VR) training with conventional rehabilitation significantly improved upper limb function compared to conventional therapy alone.

Participants in the VR group experienced notable enhancements in grip strength and overall upper extremity motor scores, indicating that VR can be a safe and effective addition to rehabilitation programs for improving upper limb function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Fully Immersive Virtual Reality Method for Upper Limb Rehabilitation in Spinal Cord Injury. Lim, DY., Hwang, DM., Cho, KH., et al.[2020]

Circuit resistance training (CRT) and high-intensity interval training (HIIT) can significantly improve cardiorespiratory fitness, muscular strength, and blood lipid levels in individuals with spinal cord injury (SCI), highlighting the importance of exercise for metabolic health in this population.

Using virtual platforms to deliver high-intensity exercise can help overcome barriers such as transportation and facility access, making it easier for individuals with SCI to engage in effective exercise programs while ensuring safety and risk mitigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Strategies for the Broad Delivery of High Intensity Exercise in Persons With Spinal Cord Injury: Ongoing Studies and Considerations for Implementation. McMillan, DW., Astorino, TA., Correa, MA., et al.[2021]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

The Effect of Virtual Reality Exercise Program on Sitting Balance Ability of Spinal Cord Injury Patients. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Effects of Virtual Reality Therapy on Gait and Balance Among Individuals With Spinal Cord Injury: A Systematic Review and Meta-analysis. [2021]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Home-Based Virtual Reality-Augmented Training Improves Lower Limb Muscle Strength, Balance, and Functional Mobility following Chronic Incomplete Spinal Cord Injury. [2022]

4. England pubmed.ncbi.nlm.nih.gov

The effects of the Nintendo™ Wii Fit on gait, balance, and quality of life in individuals with incomplete spinal cord injury. [2018]

5. Korea (South) pubmed.ncbi.nlm.nih.gov

A Fully Immersive Virtual Reality Method for Upper Limb Rehabilitation in Spinal Cord Injury. [2020]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Virtual Strategies for the Broad Delivery of High Intensity Exercise in Persons With Spinal Cord Injury: Ongoing Studies and Considerations for Implementation. [2021]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Obstacle crossing in a virtual environment with the rehabilitation gait robot LOKOMAT. [2015]