Other
Cooling 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
Spinal cord injury (SCI) >1 year in duration
Be older than 18 years old
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upbaseline (0 min) and end of thermal challenge (120 min) will be compared
Awards & highlights
No Placebo-Only Group
Study Summary
This trial is testing a "smart" cooling vest that will help people with high spinal cord injuries keep their core temperature within a normal range when exposed to warm temperatures.
Eligible Conditions
- Spinal Cord Injury
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowSelect...
You have had a spinal cord injury for more than one year.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline (0 min) and end of thermal challenge (120 min) will be compared
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (0 min) and end of thermal challenge (120 min) will be compared
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Skin temperature (Tsk) change
Thermal Sensation (TS) change
Secondary outcome measures
Core body temperature (Tcore) change
Thermal comfort (TC) change
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Arm 2: Cooling VestExperimental Treatment1 Intervention
Phase 2: Participants with Hi-SCI will wear the wet vest (experimental condition) in a warm thermal chamber (35�C) for up to 2 hours in the seated position, to determine: (1) change in Tcore and (2) perception of heat and thermal comfort.
Group II: Arm 1: Cooling VestExperimental Treatment1 Intervention
Phase 1: After satisfying bench testing criteria, AB participants will wear the wet cooling vest at maximal settings for 2 hours in the seated position in a warm thermal chamber (35�C), to determine: (1) minimum skin temperatures beneath the cooling vest and (2) subjective thermal sensation of their skin beneath the cooling vest.
Group III: Arm 3: No VestActive Control1 Intervention
Phase 2: Participants with Hi-SCI will wear no vest (control condition) in a warm thermal chamber (35�C) for up to 2 hours in the seated position, to determine: (1) change in Tcore and (2) perception of heat and thermal comfort.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cooling Vest
2017
N/A
~40
Find a site
Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,563 Previous Clinical Trials
2,889,542 Total Patients Enrolled
John Philip Handrakis, PT DPT EdDPrincipal Investigator
James J. Peters Veterans Affairs Medical Center2 Previous Clinical Trials
58 Total Patients Enrolled
Media Library
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What criteria must potential participants fulfill in order to join this trial?
"Aspiring patients of this medical trial should possess a spinal cord injury and be within the age range of 18 to 68. Fifteen people are anticipated to take part in this research endeavour."
Answered by AI
Are there still spots available for enrolment in the trial?
"According to the information available at clinicaltrials.gov, no new patients are currently being recruited for this medical trial which was first made public on February 13th 2023 and last updated August 1st 2022. However, there are currently 428 other investigations looking for volunteers."
Answered by AI
Does this trial encompass participants of all ages, including those over 25?
"This research is searching for participants of legal age who are 18 or older and younger than 68."
Answered by AI