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Behavioural Intervention

Virtual Reality Exercise for Spinal Cord Injury

N/A

Waitlist Available

Research Sponsored by Drexel University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Be at least 18 years of age

Must not have

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

Significant spasticity

Timeline

Screening 3 weeks

Treatment Varies

Follow Up enrollment, 4 weeks, 12 weeks and 16 weeks

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to develop a virtual reality exercise platform, VR-Move, specifically designed for individuals with Spinal Cord Injury (SCI) to improve their physical fitness and overall quality of life. The platform

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

There are no known risks or side effects associated with participating in this research as it involves using a virtual reality system for exercise from the safety and comfort of one's own home.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I use a wheelchair for most of my daily movements outside the home.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I experience severe muscle stiffness.

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I cannot lift my arms above 45 degrees.

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I cannot use my arms fully.

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ enrollment, 4 weeks, 12 weeks and 16 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~enrollment, 4 weeks, 12 weeks and 16 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and enrollment, 4 weeks, 12 weeks and 16 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Brief Pain Inventory

Numeric Rating Scale (NRS-Mood)

Numeric Rating Scale Nausea (NRS_Neausea)

+6 more

Secondary study objectives

Blood Pressure

Central Adiposity

Fasting blood glucose

+1 more

Other study objectives

Exercise Self Efficacy Scale (ESE)

General Sleep Disturbance Scale, GSDS

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

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Preliminary clinical efficacy and feasibility of 12-week home-based VR-Move exercise programExperimental Treatment1 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

0 / 7Eligibility criteria met