Prevention of ACL Thru Strengthening ProgramNCT01729312
Female Acl Prevention Study Where we Look at Landing Techniques Pre/Post Nine Week Strenghtening Program
An observational study of Prevention of ACL Thru Strengthening Program, run by Henry Ford Health System at 1 site in United States.
Trial summary
To make reading this consent form easier, the word "participant" refers to you or your child (if a minor) throughout the consent form. This research is being done to study the effects of an eighteen-session strengthening program and to see if there is a relationship between the female athletes improving their landing… Read more about this study
- Who is it for?
- Ages 13 to 16 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Prevention of ACL Thru Strengthening Program
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Sep 2013
- 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 13 to 16 years
- Women only
- Healthy volunteers accepted
- Child
Study population: female athletes in age of 13-16
Who may be able to join
- Exclusion Criteria:all males females younger than 13 and older than 16
- -
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study to See if There is a Improvement in Landing Techniques After a 9 Week Strenghtening Program, Which May Decrease ACL Tears in Female Athletes
To make reading this consent form easier, the word "participant" refers to you or your child (if a minor) throughout the consent form. This research is being done to study the effects of an eighteen-session strengthening program and to see if there is a relationship between the female athletes improving their landing techniques which has been proven to decrease anterior cruciate ligament injuries.
Participants have been asked to take part in a research study because you are a female athlete involved in a sport that has an increased anterior cruciate ligament injury rate. The purpose of this research study is to find out if an eighteen-session strengthening program will decrease your anterior cruciate ligament injury rate.
There will be approximately ninety-four (94) people in this research study at Henry Ford Health System (HFHS).
Read the detailed description
The purpose of this research program is to use Dartfish technology and Functional Movement Screen to assess female athletes pre- and post injury prevention program.The study will include ninety-four females: forty-seven who complete a nine week program focusing on neuromuscular and proprioceptive exercises to improve landing techniques, and forty-seven who go about their normal preseason training regimen. This program has no more risk than if each athlete were to work out at their own gym. Each athlete will be given two questionnaires before and after completing the program in order to determine their level of activity has changed as well as uncover any underlying knee issues. Participants will also go through a series of functional and movement tests to reveal any imbalances, and determine whether or not they have improved by going through the prevention program.
All functional and movement tests will be video recorded. These recordings will only be used for the purpose of conducting this research study and will only be viewed by the HFHS investigators participating in the study. We will follow-up with each athlete one year later to see if there are any lasting effects from the program and re-test each athlete at that time to validate any results
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2012 (estimated)
- Study startJan 2012
- Primary completionMar 2013
- Study completionSep 2013
Why it stopped: Not enough participants to validate study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prevention of ACL Thru Strengthening ProgramStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Blokdijk, Henry Ford Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01729312
- Sponsor's protocol ID
- female acl prevention study
- Status last verified
- Feb 2017
- First submitted
- 14 Nov 2012
- Last updated
- 27 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to See if There is a Improvement in Landing Techniques After a 9 Week Strenghtening Program, Which May Decrease ACL Tears in Female Athletes
- ClinicalTrials.gov ID
- NCT01729312
- Acronym / sponsor ID
- female acl prevention study
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Not enough participants to validate study.
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 20 Nov 2012 (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.
To make reading this consent form easier, the word "participant" refers to you or your child (if a minor) throughout the consent form. This research is being done to study the effects of an eighteen-session strengthening program and to see if there is a relationship between the female athletes improving their landing techniques which has been proven to decrease anterior cruciate ligament injuries.
Participants have been asked to take part in a research study because you are a female athlete involved in a sport that has an increased anterior cruciate ligament injury rate. The purpose of this research study is to find out if an eighteen-session strengthening program will decrease your anterior cruciate ligament injury rate.
There will be approximately ninety-four (94) people in this research study at Henry Ford Health System (HFHS).
Detailed description
The purpose of this research program is to use Dartfish technology and Functional Movement Screen to assess female athletes pre- and post injury prevention program.The study will include ninety-four females: forty-seven who complete a nine week program focusing on neuromuscular and proprioceptive exercises to improve landing techniques, and forty-seven who go about their normal preseason training regimen. This program has no more risk than if each athlete were to work out at their own gym. Each athlete will be given two questionnaires before and after completing the program in order to determine their level of activity has changed as well as uncover any underlying knee issues. Participants will also go through a series of functional and movement tests to reveal any imbalances, and determine whether or not they have improved by going through the prevention program.
All functional and movement tests will be video recorded. These recordings will only be used for the purpose of conducting this research study and will only be viewed by the HFHS investigators participating in the study. We will follow-up with each athlete one year later to see if there are any lasting effects from the program and re-test each athlete at that time to validate any results
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 13 to 16 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- female athletes in age of 13-16
Key inclusion criteria (2 listed)
- Exclusion Criteria:all males females younger than 13 and older than 16
- -
Key exclusion criteria (0 listed)
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
Not reported in the source record.
Results and safety
The study was stopped early (reason given: Not enough participants to validate study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2017.
- Individual participant dataSharing planned: No
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 Prevention of ACL Thru Strengthening Program, run by Henry Ford Health System at 1 site in United States.
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 2 inclusion and 0 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: stopped early, as of the sponsor's last update on 27 Feb 2017. 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 United States. 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 was stopped early (reason given: Not enough participants to validate study.). Results are not available in the source record.
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.
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 27 Feb 2017.