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Heated Vest for Spinal Cord Injury

N/A
Waitlist Available
Led By John Philip Handrakis, PT DPT EdD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up visits 2 & 3 (subjects with tetraplegia only): at the end baseline (at 15 min) & end of thermal challenge (at 120 min) periods. the change in cognitive performance from baseline to the end of thermal challenge will be determined. each wais is 10 min
Awards & highlights

Study Summary

This trial is testing a self-regulating heated vest to see if it can decrease the adverse impact of cool temperatures on comfort, quality of life, and performance of vital daily tasks for Veterans with tetraplegia.

Eligible Conditions
  • Spinal Cord Injury

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~visits 2 & 3 tetraplegia only): at the end baseline (at 15 min) & end of thermal challenge (at 120 min) periods. the change in cognitive performance from baseline to the end of thermal challenge will be determined. each assessment requires 6 min.
This trial's timeline: 3 weeks for screening, Varies for treatment, and visits 2 & 3 tetraplegia only): at the end baseline (at 15 min) & end of thermal challenge (at 120 min) periods. the change in cognitive performance from baseline to the end of thermal challenge will be determined. each assessment requires 6 min. 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 Cognitive Performance: Delayed Recall
Change in Cognitive Performance: Stroop
Change in Cognitive Performance: WAIS-IV (Wechsler Adult Intelligence Scale-Fourth Edition)
+1 more
Secondary outcome measures
Change in Thermal Comfort (TC)
Other outcome measures
Change in Skin Temperature (Tsk) Under the Heated Vest
Change in Thermal Sensation (TS)

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Heated Vest Safety & Comfort (able-bodied subjects)Experimental Treatment1 Intervention
Able-bodied controls will be fitted with an appropriately sized heated vest, while wearing only a standard cotton T-shirt and shorts, and will remain seated in a wheelchair. Subjects will be transferred to a pre-cooled (18 degrees C) thermal chamber and data will be collected for 2 hours with the heated vest on full power. Outcome Variables for Visit 1: Skin thermocouple temperatures, subjective ratings of thermal sensation.
Group II: Heated Vest Efficacy (persons with tetraplegia)Experimental Treatment1 Intervention
Subjects with tetraplegia, while seated and wearing only a standard cotton T-shirt and shorts, will be fitted with an appropriately sized heated vest. Subjects will be transferred to a pre-cooled (18 degrees C) thermal chamber and data will be collected for up to 2 hours with the self-regulating heated vest. Primary Dependent variables: core body temperature (Tcore), cognitive performance, and thermal comfort.
Group III: Non-Heated Vest control condition (persons with tetraplegia)Active Control1 Intervention
The same subjects with tetraplegia from the experimental arm, while seated and wearing only a standard cotton T-shirt and shorts, will be fitted with an appropriately sized, similarly insulated, but non-heated vest (control condition). Subjects will be transferred to a pre-cooled (18 degrees C) thermal chamber and data will be collected for up to 2 hours with the non-heated vest. Primary Dependent variables: core body temperature (Tcore), cognitive performance, and thermal comfort.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Heated Vest
2020
N/A
~20

Find a Location

Who is running the clinical trial?

United States Military AcademyUNKNOWN
VA Office of Research and DevelopmentLead Sponsor
1,609 Previous Clinical Trials
3,306,436 Total Patients Enrolled
John Philip Handrakis, PT DPT EdDPrincipal InvestigatorJames J. Peters Veterans Affairs Medical Center
2 Previous Clinical Trials
56 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
European Journal of Applied PhysiologyJournal
Thermal Sensation and Comfort in Transient Non-uniform Thermal Environments
Zhang, H., C. Huizenga, E. Arens, and D. Wang. 2004. “Thermal Sensation and Comfort in Transient Non-uniform Thermal Environments”. European Journal of Applied Physiology. Springer Science and Business Media LLC. doi:10.1007/s00421-004-1137-y.
clinicaltrials.govStudy
Heated Vest for Persons With Spinal Cord Injury
2020. "Heated Vest for Persons With Spinal Cord Injury". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03662308.
~3 spots leftby Apr 2025
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