Post ACL ReconstructionNCT04005274
Rate of Force Development vs Isometric Strength of Quadriceps
An observational study of Post ACL Reconstruction, run by Kaiser Permanente at 1 site in United States.
Trial summary
Peak isometric strength of quadriceps (QI) has been used to help determine an athletes ability to safely return back to sport following an anterior cruciate ligament (ACL) reconstruction surgery. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Post ACL Reconstruction
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Mar 2019to 8 Apr 2019
- 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 14 years and older
- All sexes
- Child, Adult, Older adult
Study population: Kaiser Permanente patients attending out-patient physical therapy post ACL reconstruction.
Who may be able to join
- No pain (at baseline) or edema/effusion
- Full knee range of motion
- Post Op: 20 weeks - 2 years
- Non antalgic gait
Who cannot join
- History of low back pain or other lower extremity injury within 1 year, skeletal immature, pregnant, concomitant ligament injury
Trial locations and contacts
1 site in 1 country.
United States1 site
Kaiser Permanente West Los Angeles Medical Center
West Los Angeles, California, 90034
About this study
Official title: Is Rate of Force Development (RFD) Superior to Isometric Strength (QS) of the Quadriceps as a Predictor of Functional Performance After Anterior Cruciate Ligament Reconstruction
Peak isometric strength of quadriceps (QI) has been used to help determine an athletes ability to safely return back to sport following an anterior cruciate ligament (ACL) reconstruction surgery. However, rate of force development (RFD) of the quadriceps, or how fast the quadriceps are able to reach their peak strength, is rarely used as part of this decision despite the role it plays in protecting the knee. This retrospective data only study will look back at the limb symmetry index (LSI) of patients post ACL reconstruction for the Noyes Hop Test, QI, and RFD. The hypothesis is that RFD does not recover at the same rate as Noyes Hop Test and QI.
- Conditions
- Post ACL Reconstruction
What is being measured
The primary outcome is the main question the study is designed to answer.
Limb Symmetry (Noyes hop testing, Isokinetic testing-rate of force development, Isokinetic testing-quadriceps index)
Limb symmetry was calculated comparing surgical leg over non-surgical leg giving a percentage. A percentage will be calculated for each one of the 3 observations allowing easy comparison with same unit of measure.
Measured: March - June 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2019
- Study start8 Mar 2019
- Primary completion8 Apr 2019
- Study completion8 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post ACL ReconstructionStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe 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 only
- Time perspective
- Retrospective
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04005274
- Sponsor's protocol ID
- KPSC IRB 12068
- Status last verified
- Jul 2019
- First submitted
- 20 Jun 2019
- Last updated
- 2 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Rate of Force Development (RFD) Superior to Isometric Strength (QS) of the Quadriceps as a Predictor of Functional Performance After Anterior Cruciate Ligament Reconstruction
- ClinicalTrials.gov ID
- NCT04005274
- Acronym / sponsor ID
- KPSC IRB 12068
- Conditions
- Post ACL Reconstruction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Study start
- 8 Mar 2019 (actual)
- Primary completion
- 8 Apr 2019 (actual)
- Study completion
- 8 Apr 2019 (actual)
- First posted
- 2 Jul 2019 (actual)
- 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.
Peak isometric strength of quadriceps (QI) has been used to help determine an athletes ability to safely return back to sport following an anterior cruciate ligament (ACL) reconstruction surgery. However, rate of force development (RFD) of the quadriceps, or how fast the quadriceps are able to reach their peak strength, is rarely used as part of this decision despite the role it plays in protecting the knee. This retrospective data only study will look back at the limb symmetry index (LSI) of patients post ACL reconstruction for the Noyes Hop Test, QI, and RFD. The hypothesis is that RFD does not recover at the same rate as Noyes Hop Test and QI.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Kaiser Permanente patients attending out-patient physical therapy post ACL reconstruction.
Key inclusion criteria (4 listed)
- No pain (at baseline) or edema/effusion
- Full knee range of motion
- Post Op: 20 weeks - 2 years
- Non antalgic gait
Key exclusion criteria (1 listed)
- History of low back pain or other lower extremity injury within 1 year, skeletal immature, pregnant, concomitant ligament injury
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
Limb Symmetry (Noyes hop testing, Isokinetic testing-rate of force development, Isokinetic testing-quadriceps index)
Time frame: March - June 2019
Limb symmetry was calculated comparing surgical leg over non-surgical leg giving a percentage. A percentage will be calculated for each one of the 3 observations allowing easy comparison with same unit of measure.
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 2 Jul 2019.
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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 Post ACL Reconstruction, run by Kaiser Permanente 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 1 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 2 Jul 2019. 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?
Limb Symmetry (Noyes hop testing, Isokinetic testing-rate of force development, Isokinetic testing-quadriceps index) (time frame: March - June 2019). 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 2 Jul 2019.