NCT03659474

Brief Summary

Different techniques of cryotherapy application present divergent responses. The objective was to establish differences between methods of application of ankle cryotherapy on skin surface temperature (TSP), agility and balance. The sample consisted of 20 healthy and active young men, 10 men and 10 women, with 21.4 (1.9) years. Initially, all performed the Modified Star Excursion Balance Test, Side Hop Test, and TSP collection of the lateral ankle region by digital thermography. After that, the application of the cryotherapy techniques - ice pack (PG), cold water immersion (LAI) and cryotherapy + compression by Game Ready® (CCGR), all for 20 minutes (') was randomized. The tests and TSP were reassessed in the immediate post-10'', 20'' and 30 'post. After three and six days, the other application forms were reassessed. Thus, the participants were randomly assigned to the three forms of cryotherapy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 16, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2018

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 12, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 6, 2018

Completed
Last Updated

September 6, 2018

Status Verified

April 1, 2018

Enrollment Period

Same day

First QC Date

February 16, 2018

Last Update Submit

September 4, 2018

Conditions

Temperature

Keywords

skin temperaturepostural controlankle

Outcome Measures

Primary Outcomes (1)

  • Change in skin surface temperature after intervention

    evaluated by professional thermal camera Flir C2®

    pre-intervention, Immediately after, post 10, 20 and 30 minutes

Secondary Outcomes (2)

  • Change in agility after intervention

    pre-intervention, Immediately after, post 10, 20 and 30 minutes

  • Change in postural control after intervention

    pre-intervention, Immediately after, post 10, 20 and 30 minutes

Study Arms (3)

cryotherapy by compression

EXPERIMENTAL

maximum dynamic intermittent compression, programmed to maintain a temperature at 1 ° C

Other: compression

ice pack

EXPERIMENTAL

the ankle joint was surrounded by three plastic bags containing crushed ice.

Other: ice pack

cold water immersion

EXPERIMENTAL

articulation of the ankle submerged in cold water at approximately 10 ° C, being controlled by the thermal camera.

Other: immersion

Interventions

compressionOTHER

compression by Game Ready

cryotherapy by compression
ice packOTHER

cryotherapy for ice pack

ice pack
immersionOTHER

immersion therapy

cold water immersion

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • physically active
  • no history of lower limb injuries
  • no complaints of pain at the time of collection

You may not qualify if:

  • sedentary
  • injury or ankle surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Christiane Macedo

Londrina, Paraná, 86038-350, Brazil

Location

Related Publications (1)

  • Tomchuk D, Rubley MD, Holcomb WR, Guadagnoli M, Tarno JM. The magnitude of tissue cooling during cryotherapy with varied types of compression. J Athl Train. 2010 May-Jun;45(3):230-7. doi: 10.4085/1062-6050-45.3.230.

    PMID: 20446835BACKGROUND

MeSH Terms

Interventions

Immersion

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Christiane Macedo

    State University of Londrina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2018

First Posted

September 6, 2018

Study Start

April 1, 2018

Primary Completion

April 1, 2018

Study Completion

July 12, 2018

Last Updated

September 6, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)