Injury of Anterior Cruciate LigamentNCT01937403
Sport Cord Test Following ACL Reconstruction
An observational study of Injury of Anterior Cruciate Ligament, run by The Hawkins Foundation at 1 site in United States.
Trial summary
The primary purpose of this study is to determine the interrater reliability and validity of the Sportcord Test as a measure of physical performance following anterior cruciate ligament (ACL) reconstruction. Read more about this study
- Who is it for?
- Ages 10 to 50 years
- Conditions the study is for
- Injury of Anterior Cruciate Ligament
- How many people
- 171 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Mar 2016
- 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 10 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients receiving physical therapy/rehabilitation for an ACL surgery and are returning to participation in sports.
Who may be able to join
- Undergoing surgical reconstruction for a torn ACL.
- Returning to participation in a sport(s).
- Will receive physical therapy/rehabilitation after surgical reconstruction for a torn ACL.
- Between ages of 10 and 50.
Who cannot join
- Non-weight bearing.
- At least 12 weeks removed from surgery.
- Unable to walk, squat, or jump/land without pain in the surgically repaired knee.
Trial locations and contacts
1 site in 1 country.
United States1 site
ATI Physical Therapy
Greenville, South Carolina, 29615
About this study
Official title: The Use of the Sport Cord Test as a Measure of Physical Performance Following Anterior Cruciate Ligament Reconstruction
The primary purpose of this study is to determine the interrater reliability and validity of the Sportcord Test as a measure of physical performance following anterior cruciate ligament (ACL) reconstruction. A secondary purpose is to systematically track subjective and objective outcomes on patients following ACL reconstruction to help identify differences between those who have subsequent knee problems and those who do not. The study hypotheses are the following:
- The Sportcord Test will provide a valid and reliable measure of functional performance following ACL reconstruction. 2) Patients who have subsequent knee problems in the 12 month study period will exhibit different scores on clinical special tests compared to those who do not.
- Conditions
- Injury of Anterior Cruciate Ligament
- Keywords
- Physical Therapy, Return to sport
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What is being measured
The primary outcome is the main question the study is designed to answer.
Sportcord Test
The Sportcord Test measures physical performance following an ACL reconstruction. The Sportcord test consists of the following:
- single-leg squats
- lateral (side-to-side) agility
- forward running
- backward running
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2013 (estimated)
- Study startOct 2009
- Primary completionAug 2015
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Injury of Anterior Cruciate LigamentStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 171 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hawkins Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ellen Shanley, PT, PhD, OCS, CSCS, Principal investigator, ATI Physical Therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01937403
- Sponsor's protocol ID
- Pro00003653
- Status last verified
- Mar 2016
- First submitted
- 4 Sep 2013
- Last updated
- 5 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of the Sport Cord Test as a Measure of Physical Performance Following Anterior Cruciate Ligament Reconstruction
- ClinicalTrials.gov ID
- NCT01937403
- Acronym / sponsor ID
- Pro00003653
- Conditions
- Injury of Anterior Cruciate Ligament
- Keywords
- Physical Therapy, Return to sport
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 171 participants (actual)
- Lead sponsor
- The Hawkins FoundationUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Aug 2015 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 9 Sep 2013 (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 primary purpose of this study is to determine the interrater reliability and validity of the Sportcord Test as a measure of physical performance following anterior cruciate ligament (ACL) reconstruction. A secondary purpose is to systematically track subjective and objective outcomes on patients following ACL reconstruction to help identify differences between those who have subsequent knee problems and those who do not. The study hypotheses are the following:
- The Sportcord Test will provide a valid and reliable measure of functional performance following ACL reconstruction. 2) Patients who have subsequent knee problems in the 12 month study period will exhibit different scores on clinical special tests compared to those who do not.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 10 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients receiving physical therapy/rehabilitation for an ACL surgery and are returning to participation in sports.
Key inclusion criteria (4 listed)
- Undergoing surgical reconstruction for a torn ACL.
- Returning to participation in a sport(s).
- Will receive physical therapy/rehabilitation after surgical reconstruction for a torn ACL.
- Between ages of 10 and 50.
Key exclusion criteria (3 listed)
- Non-weight bearing.
- At least 12 weeks removed from surgery.
- Unable to walk, squat, or jump/land without pain in the surgically repaired knee.
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
Sportcord Test
Time frame: one year
The Sportcord Test measures physical performance following an ACL reconstruction. The Sportcord test consists of the following: 1. single-leg squats 2. lateral (side-to-side) agility 3. forward running 4. backward running
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 5 Jul 2018.
- Individual participant dataSharing planned: No
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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.
Ellen Shanley, PT, PhD, OCS, CSCS principal investigator
ATI Physical Therapy
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 Injury of Anterior Cruciate Ligament, run by The Hawkins Foundation 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 4 inclusion and 3 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 5 Jul 2018. 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 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?
Sportcord Test (time frame: one year). 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 5 Jul 2018.