- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00996398
Cold Water Immersion Does Not Reduce Knee Joint Position Sense in Healthy Participants: a Randomised Cross-over Trial
Cold Water Immersion Does Not Reduce Knee Joint Position Sense in Healthy Participants: a Randomised Cross-over Trial'
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Limerick, Ireland
- University of Limerick
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cold water immersion
14°C ± 1°C for the cold water immersion for 30 minutes to the level of the umbilicus
|
28°C ± 1°C for the cold water immersion for 30 minutes to the level of the umbilicus
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Knee Joint Position Sense
Time Frame: 10 minutes pre and 5 minutes post immersion
|
10 minutes pre and 5 minutes post immersion
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Alan E Donnelly, PhD, University of Limerick
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- ULREC 09/11
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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