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Educational Modules for Spinal Cord Injury

N/A
Recruiting
Led By Mark Nash, PhD
Research Sponsored by University of Miami
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Men and Women with SCI/D aged 18-70 years
Neurologically complete and incomplete American Spinal Injury Association (ASIA) Impairment scale (AIS) A-D spinal cord levels C5 and below
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, up to 6 months
Awards & highlights

Study Summary

This trial tests if teaching people about heart & metabolic diseases helps them understand & improve their health.

Who is the study for?
This trial is for men and women aged 18-70 with spinal cord injury/disease (SCI/D), enrolled within 4 months after initial rehab. Participants should have complete or incomplete SCI at levels C5 and below, as per the ASIA Impairment Scale. It's not for prisoners, pregnant women, or those with cognitive impairments affecting consent.Check my eligibility
What is being tested?
The study tests if education on cardiometabolic disease risks using PVA Consumer Guide and WebMD improves understanding of these risks in people with SCI/D. The goal is to see how this knowledge affects their health management.See study design
What are the potential side effects?
Since the interventions are educational materials, there are no direct medical side effects expected from participating in this trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 70 years old with a spinal cord injury or disorder.
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My spinal cord injury is at level C5 or lower and is classified as ASIA A-D.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, up to 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, up to 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Effectiveness of education modules as determined in the Knowledge Test
Secondary outcome measures
Change in Body Weight as determined by kilograms (kg)
Change in Body composition as determined by Dual X-ray Absorptiometry (DXA)
Change in Body composition as determined by Dual X-ray Absorptiometry (DXA) in Percentage
+5 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Paralyzed Veterans of America (PVA) Cardio-Metabolic Disease (CMD) Consumer Guide GroupExperimental Treatment1 Intervention
Hard paper copy of as well as an electronic copy of the guide will be provided to subjects and study staff will provide a general review of the contents of the guide with subjects during their education sessions. Participants will be in this group for 6 months.
Group II: WebMD GroupActive Control1 Intervention
Subjects will be introduced to WebMD and its contents. A brief document will be provided that includes site summary and website. Study staff will provide a very brief overview of the site. Participants will be in this group for 6 months.

Find a Location

Who is running the clinical trial?

University of MiamiLead Sponsor
902 Previous Clinical Trials
409,826 Total Patients Enrolled
21 Trials studying Obesity
8,658 Patients Enrolled for Obesity
National Institute on Disability, Independent Living, and Rehabilitation ResearchFED
71 Previous Clinical Trials
8,879 Total Patients Enrolled
1 Trials studying Obesity
22 Patients Enrolled for Obesity
Mark Nash, PhDPrincipal InvestigatorUniversity of Miami
1 Previous Clinical Trials
10 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there an opportunity for me to take part in this clinical experiment?

"To participate in this trial, would-be participants must have been diagnosed with spinal cord injury and be between 18 and 70 years old. This study will involve 250 people across all its sites."

Answered by AI

Is eligibility for this clinical study limited to people that are over 20 years of age?

"According to the provided requirements, only individuals between 18 and 70 years old can join this research. There are also 338 studies available for minors and 1,462 projects open for those over 65."

Answered by AI

How many sites are facilitating this clinical trial?

"There are 5 clinical sites actively enrolling participants in this trial. These include the University of Miami - Miami Project to Cure Paralysis, University of Minnesota Rehabilitation, and Baylor Scott & White Institute for Research alongside another 5 locations."

Answered by AI

Is there any capacity for new participants to join this medical experiment?

"This clinical trial, which was initially posted on October 31st 2023 and updated most recently on August 16th 2023 is not actively recruiting. However, there are plenty of other active trials with over two thousand available right now."

Answered by AI

Who else is applying?

What site did they apply to?
Baylor Scott & White Institute for Research
McGuire Research Institute Richmond VA Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Spinal Cord Injury Model Systems (SCIMS) - Education Module
Mark S. Nash, Ph.D., FACSM 2024. "Spinal Cord Injury Model Systems (SCIMS) - Education Module". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06003686.
All > Metabolic Syndrome
~167 spots leftby Oct 2025
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