Knee Joint Position SenseNCT00996398
Cold Water Immersion Does Not Reduce Knee Joint Position Sense in Healthy Participants: a Randomised Cross-over Trial
A study testing Tepid water immersion in people with Knee Joint Position Sense, run by University of Limerick at 1 site in Ireland.
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… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Knee Joint Position Sense
- What is being tested?
- Tepid water immersion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteIreland
- Study dates
- May 2009to Sep 2009
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subjects between the ages of 18 and 40 who complete both a Par-Q test and sign an informed consent form.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed 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.
- Conditions
- Knee Joint Position Sense
- Being tested
- Tepid water immersion
- Keywords
- Cryotherapy, Joint Position Sense, Proprioception, Pre Cooling, Knee Injury, Physical Therapy Modalities, Physical Therapy Techniques, Weightbearing, NonWeightbearing, Randomised Control Trial
- Medical subject headings
- Knee Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tepid water immersionOther
28°C ± 1°C for the cold water immersion for 30 minutes to the level of the umbilicus
| Study group | Role | What they receive |
|---|---|---|
| Cold water immersion | Experimental | 14°C ± 1°C for the cold water immersion for 30 minutes to the level of the umbilicus Receives: Other: Tepid water immersion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee Joint Position Sense
Measured: 10 minutes pre and 5 minutes post immersion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2009 (estimated)
- Study startMay 2009
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee Joint Position SenseStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Limerick
- Sponsor type
- University, hospital or other
- Investigators
- Alan E Donnelly, PhD, Principal investigator, University of Limerick
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00996398
- Sponsor's protocol ID
- ULREC 09/11
- Status last verified
- Oct 2009
- First submitted
- 14 Oct 2009
- Last updated
- 16 Oct 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cold Water Immersion Does Not Reduce Knee Joint Position Sense in Healthy Participants: a Randomised Cross-over Trial'
- ClinicalTrials.gov ID
- NCT00996398
- Acronym / sponsor ID
- ULREC 09/11
- Conditions
- Knee Joint Position Sense
- Keywords
- Cryotherapy, Joint Position Sense, Proprioception, Pre Cooling, Knee Injury, Physical Therapy Modalities, Physical Therapy Techniques, Weightbearing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of LimerickUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 16 Oct 2009 (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 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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cold water immersion | Experimental | Other: Tepid water immersion14°C ± 1°C for the cold water immersion for 30 minutes to the level of the umbilicus |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy subjects between the ages of 18 and 40 who complete both a Par-Q test and sign an informed consent form.
Key exclusion criteria (6 listed)
- 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.
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 |
|---|---|---|
| Tepid water immersion28°C ± 1°C for the cold water immersion for 30 minutes to the level of the umbilicus | Other | Cold water immersion |
Primary outcome
Knee Joint Position Sense
Time frame: 10 minutes pre and 5 minutes post immersion
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 16 Oct 2009.
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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.
Alan E Donnelly, PhD principal investigator
University of Limerick
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tepid water immersion in people with Knee Joint Position Sense, run by University of Limerick at 1 site in Ireland.
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 1 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 16 Oct 2009. 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 Ireland. 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. 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?
Knee Joint Position Sense (time frame: 10 minutes pre and 5 minutes post immersion). 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 16 Oct 2009.