HealthyNCT01961596
The Influence of a "Cooling Ice Spray " Application on the Time to Stability After a Forward Jump?
A study testing Cooling Ice Spray and water in people with Healthy, run by Swanenburg at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Cooling Ice Spray and water
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteSwitzerland
- Study dates
- Oct 2013to Mar 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy adults
- 18-45 age
- >3 Score "Tegner-Activity-Scale"
Who cannot join
- Cognitive deficits
- Physical disability
- Pain
- Injuries in the previous 6 weeks
- Non healed injuries at the leg
- Allergic reaction from cooling ice pray
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Balgrist Univeresty Hospital
Zurich, Canton of Zurich, 8008
About this study
Official title: Does Have a Short-term "Cooling Ice Spray" Application at the Lateral Ankle an Influence on the Time to Stability After a Forward Jump?
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.
Read the detailed description
In sports are "Cooling Ice Spray" applications after an injuries one of the most common and popular methods used. It is very popular mainly because of its analgesic effect and easy application. It is assumed that such application will not affect the athletes. Nevertheless after an application of cold a reduced nerve conduction velocity was measured, resulting in a reduction in pain and a reduced transmission rate. Usually the static equilibrium or the perception of joint position was investigated and not the time to stability. As far as we have been known so far been no study that has examined the impact of a brief application of cooling ice spray on the time to stability after dynamic function. Therefore this study what's to investigate the influence of "Cooling Ice Spray" on the time to stability after a forward jump.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cooling Ice SprayOther
Also called Perskindol Cool Spray
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.
waterOther
Also called Placebo water
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to stability
Immediately after the application the time to stability after a forward jump will be assessed.
Measured: All measurements will be executed within 1hour. After 2 days the measurements will be repeated
Secondary outcomes (2)
Skin temperature
Immediately after the application the Skin temperature will be assessed.
Measured: All measurements will be executed within 1hour. After 2 days the measurements will be repeated
Side step time to stability
Immediately after the application the time to stability after side step will be assessed.
Measured: All measurements will be executed within 1hour. After 2 days the measurements will be repeated
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionFeb 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swanenburg
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Swanenburg, Balgrist University Hospital
- Investigators
- Jaap Swanenburg, PhD, Principal investigator, Balgrist Univeresty Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01961596
- Sponsor's protocol ID
- Balgrist 2013-0359
- Other IDs
- KEK-ZH-Nr. 2013-0359
- Status last verified
- Jul 2016
- First submitted
- 8 Oct 2013
- Last updated
- 20 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Have a Short-term "Cooling Ice Spray" Application at the Lateral Ankle an Influence on the Time to Stability After a Forward Jump?
- ClinicalTrials.gov ID
- NCT01961596
- Acronym / sponsor ID
- Balgrist 2013-0359
- Conditions
- Healthy
- Keywords
- Cooling ice spray, Time to stability, Jump
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- SwanenburgUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 11 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In sports are "Cooling Ice Spray" applications after an injuries one of the most common and popular methods used. It is very popular mainly because of its analgesic effect and easy application. It is assumed that such application will not affect the athletes. Nevertheless after an application of cold a reduced nerve conduction velocity was measured, resulting in a reduction in pain and a reduced transmission rate. Usually the static equilibrium or the perception of joint position was investigated and not the time to stability. As far as we have been known so far been no study that has examined the impact of a brief application of cooling ice spray on the time to stability after dynamic function. Therefore this study what's to investigate the influence of "Cooling Ice Spray" on the time to stability after a forward jump.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cooling ice | Experimental | Other: Cooling Ice SprayA 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. |
| water | Placebo comparator | Other: waterA 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- healthy adults
- 18-45 age
- >3 Score "Tegner-Activity-Scale"
Key exclusion criteria (6 listed)
- Cognitive deficits
- Physical disability
- Pain
- Injuries in the previous 6 weeks
- Non healed injuries at the leg
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cooling Ice SprayAlso: Perskindol Cool SprayA 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. | Other | cooling ice |
| waterAlso: Placebo waterA 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. | Other | water |
Primary outcome
Time to stability
Time frame: All measurements will be executed within 1hour. After 2 days the measurements will be repeated
Immediately after the application the time to stability after a forward jump will be assessed.
2 secondary outcomes
Skin temperature
Time frame: All measurements will be executed within 1hour. After 2 days the measurements will be repeated
Side step time to stability
Time frame: All measurements will be executed within 1hour. After 2 days the measurements will be repeated
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jaap Swanenburg, PhD principal investigator
Balgrist Univeresty Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cooling Ice Spray and water in people with Healthy, run by Swanenburg at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to stability (time frame: All measurements will be executed within 1hour. After 2 days the measurements will be repeated). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2016.