Healthy IndividualsNCT02096796
Arm Pump in Motorcross Training
An observational study of Healthy Individuals and Patients With Arm Pump, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
Arm Pump is a sport specific term drivers use to describe Acute or Chronic Compartment Syndrome of the forearm. Drivers experience pain in the forearms due to increased blood pressure in forearm muscle compartments. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Individuals, Patients With Arm Pump
- How many people
- 11 participants
- Where
- 1 siteBelgium
- Study dates
- Apr 2014to May 2015
- Phase
- Observational
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Recreational or competitive motor cycle athletes
Who may be able to join
- recreational or competitive motor cycling athletes
- with or without arm pump problems
- signing informed consent
- participation with their own motor bike
- Regular training hours
Who cannot join
- Inactive for more than 2 weeks before participation
- Pathology at shoulder, elbow or wrist level (except for arm pump)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hand Strength Grip and Ergonomics of Driving as Risk Factors in the Etiology of Arm Pump in Motorcross Training
Arm Pump is a sport specific term drivers use to describe Acute or Chronic Compartment Syndrome of the forearm. Drivers experience pain in the forearms due to increased blood pressure in forearm muscle compartments. No strategies nor methods have been used to diminish the risk to suffer from arm pump within motor cross.
This project aims to look at ergonomics of driving and its relationship with the occurrence of arm pump.
Read more
The investigators will first investigate the experience of motor cross athletes with arm pump through motor cross federations in Belgium and The Netherlands (survey).
Two groups of athletes will be selected (20 persons within each group) who will be invited to the motor cross track to investigate their hand grip strength, motor driving position, muscle activity.
- Conditions
- Healthy Individuals, Patients With Arm Pump
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| persons without arm pump | Not described | |
| persons with arm pump | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
motor ergonomics
2D video-recording will be used to observe motor sitting position
Measured: March - June 2014 (3 months)
Secondary outcomes (1)
hand grip strength
Use of hand grip dynamometer (Biometrics) to measure hand grip strength.
Measured: March - June 2014 (3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2014 (estimated)
- Study startApr 2014
- Primary completionDec 2014
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy IndividualsStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. F. Staes, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02096796
- Sponsor's protocol ID
- S56412
- Status last verified
- Sep 2015
- First submitted
- 21 Mar 2014
- Last updated
- 17 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hand Strength Grip and Ergonomics of Driving as Risk Factors in the Etiology of Arm Pump in Motorcross Training
- ClinicalTrials.gov ID
- NCT02096796
- Acronym / sponsor ID
- S56412
- Conditions
- Healthy Individuals, Patients With Arm Pump
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 26 Mar 2014 (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.
Arm Pump is a sport specific term drivers use to describe Acute or Chronic Compartment Syndrome of the forearm. Drivers experience pain in the forearms due to increased blood pressure in forearm muscle compartments. No strategies nor methods have been used to diminish the risk to suffer from arm pump within motor cross.
This project aims to look at ergonomics of driving and its relationship with the occurrence of arm pump.
The investigators will first investigate the experience of motor cross athletes with arm pump through motor cross federations in Belgium and The Netherlands (survey).
Two groups of athletes will be selected (20 persons within each group) who will be invited to the motor cross track to investigate their hand grip strength, motor driving position, muscle activity.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| persons without arm pump | – | – |
| persons with arm pump | – | – |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Recreational or competitive motor cycle athletes
Key inclusion criteria (5 listed)
- recreational or competitive motor cycling athletes
- with or without arm pump problems
- signing informed consent
- participation with their own motor bike
- Regular training hours
Key exclusion criteria (2 listed)
- Inactive for more than 2 weeks before participation
- Pathology at shoulder, elbow or wrist level (except for arm pump)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
motor ergonomics
Time frame: March - June 2014 (3 months)
2D video-recording will be used to observe motor sitting position
1 secondary outcome
hand grip strength
Time frame: March - June 2014 (3 months)
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 17 Sep 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Individuals and Patients With Arm Pump, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 5 inclusion and 2 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 17 Sep 2015. 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 Belgium. 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?
motor ergonomics (time frame: March - June 2014 (3 months)). 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 17 Sep 2015.