NCT01961596

Brief Summary

The aim of this study is to investigate the influence of a brief application of cold (by means of Cooling Ice Spray on the lateral ankle)on the time to stabilization of healthy subjects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Oct 2013

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

October 8, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 11, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

July 20, 2016

Status Verified

July 1, 2016

Enrollment Period

4 months

First QC Date

October 8, 2013

Last Update Submit

July 19, 2016

Conditions

Keywords

Cooling ice sprayTime to stabilityJump

Outcome Measures

Primary Outcomes (1)

  • Time to stability

    Immediately after the application the time to stability after a forward jump will be assessed.

    All measurements will be executed within 1hour. After 2 days the measurements will be repeated

Secondary Outcomes (2)

  • Skin temperature

    All measurements will be executed within 1hour. After 2 days the measurements will be repeated

  • Side step time to stability

    All measurements will be executed within 1hour. After 2 days the measurements will be repeated

Study Arms (2)

cooling ice

EXPERIMENTAL

A bursts of the "Cooling Ice Spray" over a period of 10 seconds (15 cm distance) will be applied at the dominant foot in before each test. After 2 days the measurements will be repeated with the other application.

Other: Cooling Ice Spray

water

PLACEBO COMPARATOR

A bursts of the water spray (room temperature over a period of 10 seconds (15 cm distance) will be applied at the dominant foot in before each test. After 2 days the measurements will be repeated with the other application.

Other: water

Interventions

A bursts of the "Cooling Ice Spray" over a period of 10 seconds (15 cm distance) will be applied at the dominant foot in before each test.

Also known as: Perskindol Cool Spray
cooling ice
waterOTHER

A bursts of the water spray (room temperature over a period of 10 seconds (15 cm distance) will be applied at the dominant foot in before each test.

Also known as: Placebo water
water

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy adults
  • age
  • \>3 Score "Tegner-Activity-Scale"

You may not qualify if:

  • Cognitive deficits
  • Physical disability
  • Pain
  • Injuries in the previous 6 weeks
  • Non healed injuries at the leg
  • Allergic reaction from cooling ice pray

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Balgrist Univeresty Hospital

Zurich, Canton of Zurich, 8008, Switzerland

Location

MeSH Terms

Interventions

Water

Intervention Hierarchy (Ancestors)

HydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen Compounds

Study Officials

  • Jaap Swanenburg, PhD

    Balgrist Univeresty Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

October 8, 2013

First Posted

October 11, 2013

Study Start

October 1, 2013

Primary Completion

February 1, 2014

Study Completion

March 1, 2014

Last Updated

July 20, 2016

Record last verified: 2016-07

Data Sharing

IPD Sharing
Will not share

Locations