MedTrace Logo

Heated Vest for Persons With Spinal Cord Injury

NCT03662308 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2024-05-06

Study results available
· View outcomes & findings →

Summary

Persons with higher levels of spinal cord injury (above the 2nd thoracic vertebrae; tetraplegia) are unable to maintain normal core body temperature (Tcore) when exposed to cool environments. In persons with tetraplegia, even limited exposure to cool temperatures may cause Tcore to approach hypothermic values and impair cognitive performance. Conversely, an increase in Tcore from subnormal to normal range may improve cognitive performance. Prior work has shown that cool seasonal temperatures have an adverse effect on personal comfort and the ability to perform vital daily activities of self-care in persons with tetraplegia. Interventions that address the vulnerability to hypothermia are limited. A self-regulating heated vest designed specifically for persons with tetraplegia is a novel and promising strategy to address this problem. By more effectively maintaining Tcore, the vest can decrease the adverse impact of cool temperatures on comfort, quality of life, and performance of vital daily tasks for Veterans with tetraplegia during the cooler seasons.

Conditions

  • Spinal Cord Injuries

Interventions

DEVICE

Heated Vest

Heated vest that regulates its heat output based on the user's skin, the user's core temperature, and the ambient temperature

DEVICE

Non-Heated Vest

A similarly insulated (compared to the experimental vest), but non-heated vest

Sponsors & Collaborators

  • United States Military Academy West Point

    collaborator FED

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • John Philip Handrakis, PT DPT EdD · James J. Peters Veterans Affairs Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
68 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-02-25
Primary Completion
2022-10-31
Completion
2022-10-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03662308 on ClinicalTrials.gov