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Rate of Tissue Temperature Reduction Between Wetted Ice and Game Ready

NCT04019392 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2020-02-26

No results posted yet for this study

Summary

This study compares the tissue temperature decrease between a wetted ice bag (ice and water) with an elastic wrap to the Game Ready® treatment. The goal is to determine which one decreases the temperature the most and the fastest, which is important in immediate care treatments of a musculoskeletal injury.

Conditions

  • Cryotherapy Effect

Interventions

DEVICE

Game Ready® device

The half leg boot sleeve of the Game Ready® device (CoolSystems, Inc., Alamda, CA) will be applied to each participants' lower leg and ankle for 30 minutes set on the medium pressure setting (5-50 mmHG).

OTHER

Wetted Ice Bag with Elastic Wrap

A standard ice bag filled with 2000 mL of cubed ice and 300 mL of 5˚C water will be applied using an elastic wrap to each participants' lower leg for 30 minutes. An elastic wrap applied at approximately 75% percent tension starting distal to the treatment area and moving proximally overlapping by half will be applied over the wetted ice bag.

Sponsors & Collaborators

  • North Dakota State University

    lead OTHER

Principal Investigators

  • Kara Gange, PhD, ATC · Kara Gange

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2019-09-27
Primary Completion
2019-10-15
Completion
2020-02-02
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT04019392 on ClinicalTrials.gov