ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTIONNCT04130308
Predictive Factors for a Successful Return to Run After ACL-R
A study testing Retrun to run protocol in people with ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION, run by Laval University at 1 site in Canada.
Trial summary
After anterior cruciate ligament (LCA) rupture, the recommended treatment for athletes is the surgical reconstruction of the ligament (ACL-R), followed by a long rehabilitation period. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION
- What is being tested?
- Retrun to run protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteCanada
- Study dates
- 10 Jan 2018to 30 Apr 2019
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ACL-R 3 to 4 months ago
- healthy person
Who cannot join
- already returned to run
- multiple ligament lesions
- Control group
- history of ACL lesion or reconstruction
- history of knee injury
- injured in the last year
Trial locations and contacts
1 site in 1 country.
Canada1 site
Center for Interdisciplinary Research in Rehabilitation and Social Integration (CIRRIS)
Québec, Quebec
About this study
Official title: Predictive Factors for a Successful Return to Run After Anterior Cruciate Ligament Reconstruction and Underlying Bio-mechanical Factors
After anterior cruciate ligament (LCA) rupture, the recommended treatment for athletes is the surgical reconstruction of the ligament (ACL-R), followed by a long rehabilitation period. The results of this treatment are sub-optimal with a low rate of return to pre-injury level of sport, a high risk of reinjury and early knee osteoarthritis. To improve treatment outcomes, researchers and clinicians recommend optimizing rehabilitation protocols. They recommend individualizing rehabilitation progression based on objective criteria. However, current defined criteria relied on experts' opinions and not scientific validation.
Return to run after ACL reconstruction is an important rehabilitation milestone. It often means the beginning of the return to sport continuum. A successful return to run is therefore crucial for both the patient and clinician. In this study, the investigators aim to determine the predictive outcomes for a successful return to run after ACL-R.
- Being tested
- Retrun to run protocol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retrun to run protocolOther
Progressive return to run protocol for patients after ACL-R
| Study group | Role | What they receive |
|---|---|---|
| ACL-R | Experimental | Not described Receives: Other: Retrun to run protocol |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscular strength assessment
Quadriceps, hamstring and gluteus strength assessment with handheld dynamometer (N)
Measured: Day 0
Modified Y-balance test
Modified Y-balance test (m)
Measured: Day 0
step-down test
endurance test, number of repetition
Measured: Day 0
Self-reported outcomes: ACL-RSI
ACL-RSI: 0-100
Measured: Day 0
Self-reported outcomes: IKDC
IKDC: 0-100
Measured: Day 0
Secondary outcomes (3)
Running kinematic
knee kinematic (degree)
Measured: Day 0 and Day 14
Running kinetic
kinetic (N)
Measured: Day 0 and Day 14
Knee joint contact force
knee joint contact force (N)
Measured: Day 0 and Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2019
- Study start10 Jan 2018
- Primary completion30 Apr 2019
- Study completion30 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTIONStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Collaborators
- Ordre Professionnel de la Physiothérapie du Québec (OPPQ)
- Responsible party
- Principal investigator, Jean-Sébastien Roy, Laval University
- Investigators
- Jean-Sébastien Roy, PhD, Principal investigator, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04130308
- Sponsor's protocol ID
- ACLR/Running 2019
- Status last verified
- Oct 2019
- First submitted
- 11 Oct 2019
- Last updated
- 17 Oct 2019
- 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 17 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Factors for a Successful Return to Run After Anterior Cruciate Ligament Reconstruction and Underlying Bio-mechanical Factors
- ClinicalTrials.gov ID
- NCT04130308
- Acronym / sponsor ID
- ACLR/Running 2019
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Collaborators
- Ordre Professionnel de la Physiothérapie du Québec (OPPQ)
- Study start
- 10 Jan 2018 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 30 Apr 2019 (actual)
- First posted
- 17 Oct 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.
After anterior cruciate ligament (LCA) rupture, the recommended treatment for athletes is the surgical reconstruction of the ligament (ACL-R), followed by a long rehabilitation period. The results of this treatment are sub-optimal with a low rate of return to pre-injury level of sport, a high risk of reinjury and early knee osteoarthritis. To improve treatment outcomes, researchers and clinicians recommend optimizing rehabilitation protocols. They recommend individualizing rehabilitation progression based on objective criteria. However, current defined criteria relied on experts' opinions and not scientific validation.
Return to run after ACL reconstruction is an important rehabilitation milestone. It often means the beginning of the return to sport continuum. A successful return to run is therefore crucial for both the patient and clinician. In this study, the investigators aim to determine the predictive outcomes for a successful return to run after ACL-R.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACL-R | Experimental | Other: Retrun to run protocol |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ACL-R 3 to 4 months ago
- healthy person
Key exclusion criteria (6 listed)
- already returned to run
- multiple ligament lesions
- Control group
- history of ACL lesion or reconstruction
- history of knee injury
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 |
|---|---|---|
| Retrun to run protocolProgressive return to run protocol for patients after ACL-R | Other | ACL-R |
Primary outcome
Muscular strength assessment
Time frame: Day 0
Quadriceps, hamstring and gluteus strength assessment with handheld dynamometer (N)
Modified Y-balance test
Time frame: Day 0
Modified Y-balance test (m)
step-down test
Time frame: Day 0
endurance test, number of repetition
Self-reported outcomes: ACL-RSI
Time frame: Day 0
ACL-RSI: 0-100
Self-reported outcomes: IKDC
Time frame: Day 0
IKDC: 0-100
3 secondary outcomes
Running kinematic
Time frame: Day 0 and Day 14
Running kinetic
Time frame: Day 0 and Day 14
Knee joint contact force
Time frame: Day 0 and Day 14
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 Oct 2019.
- Individual participant dataSharing planned: No
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The Effect of Isokinetic Vs Plyometric Training in Post-ACLR Surgery
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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.
Jean-Sébastien Roy, PhD principal investigator
Laval University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Retrun to run protocol in people with ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION, run by Laval University at 1 site in Canada.
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 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 17 Oct 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 Canada. 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?
Muscular strength assessment (time frame: Day 0). The study lists 5 primary outcomes in all. 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 Oct 2019; AzTrials last refreshed its copy on 31 Oct 2026.