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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00996398
Other study ID # ULREC 09/11
Secondary ID
Status Completed
Phase N/A
First received October 14, 2009
Last updated October 15, 2009
Start date May 2009
Est. completion date September 2009

Study information

Verified date October 2009
Source University of Limerick
Contact n/a
Is FDA regulated No
Health authority Ireland: Research Ethics Committee
Study type Interventional

Clinical Trial Summary

The aim of this project is to assess the effect of cold water immersion on knee joint re-positional sense in healthy subjects. Cryotherapy, in the form of cold water immersion, had previously been shown to improve athletic performance however, debate exists within the existing literature regarding whether proprioception, in the form or joint position sense, is effected post treatment.

Null hypothesis (H0): Water immersion has no effect on joint position sense (JPS).

Alternate hypothesis (H1): Water immersion has an effect on joint position sense.


Description:

This was a prospective, randomised, cross-over design where volunteers acted as their own controls. The volunteers were immersed at two temperatures (detailed below) and these sessions were separated by six to ten days. The order of the testing was randomly assigned using a random number generator. Ethical approval of the design of this trial was gained from the University of Limerick's Research Ethics Committee and signed informed consent was gained from each participant before any data collection took place.


Recruitment information / eligibility

Status Completed
Enrollment 14
Est. completion date September 2009
Est. primary completion date September 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria:

- Healthy subjects between the ages of 18 and 40 who complete both a Par-Q test and sign an informed consent form.

Exclusion Criteria:

- Potential subjects who do not complete a Par-Q questionnaire or provide written consent. Subjects with any ankle or knee injuries in the past twelve months.

- Students who have a recent history of ear or vestibular conditions.

- Subjects who will not be available to attend all sessions.

- Subjects who are under the age of 18 or over the age of 40.

- Subjects who aren't comfortable with being blind-folded or videotaped during testing.

- Those who are sensitive to cold exposure or show signs of a contraindication to cryotherapy.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
Tepid water immersion
28°C ± 1°C for the cold water immersion for 30 minutes to the level of the umbilicus

Locations

Country Name City State
Ireland University of Limerick Limerick

Sponsors (1)

Lead Sponsor Collaborator
University of Limerick

Country where clinical trial is conducted

Ireland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Knee Joint Position Sense 10 minutes pre and 5 minutes post immersion No