Predictive Factors for a Successful Return to Run After ACL-R
1 other identifier
interventional
72
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 10, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2019
CompletedFirst Submitted
Initial submission to the registry
October 11, 2019
CompletedFirst Posted
Study publicly available on registry
October 17, 2019
CompletedOctober 17, 2019
October 1, 2019
1.3 years
October 11, 2019
October 15, 2019
Conditions
Outcome Measures
Primary Outcomes (5)
Muscular strength assessment
Quadriceps, hamstring and gluteus strength assessment with handheld dynamometer (N)
Day 0
Modified Y-balance test
Modified Y-balance test (m)
Day 0
step-down test
endurance test, number of repetition
Day 0
Self-reported outcomes: ACL-RSI
ACL-RSI: 0-100
Day 0
Self-reported outcomes: IKDC
IKDC: 0-100
Day 0
Secondary Outcomes (3)
Running kinematic
Day 0 and Day 14
Running kinetic
Day 0 and Day 14
Knee joint contact force
Day 0 and Day 14
Study Arms (2)
ACL-R
EXPERIMENTALControl
NO INTERVENTIONInterventions
Eligibility Criteria
You may qualify if:
- ACL-R 3 to 4 months ago
You may not qualify if:
- already returned to run
- multiple ligament lesions
- Control group
- \- healthy person
- history of ACL lesion or reconstruction
- history of knee injury
- injured in the last year
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Center for Interdisciplinary Research in Rehabilitation and Social Integration (CIRRIS)
Québec, Quebec, Canada
Study Officials
- PRINCIPAL INVESTIGATOR
Jean-Sébastien Roy, PhD
Laval University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor, Faculty of Medicine
Study Record Dates
First Submitted
October 11, 2019
First Posted
October 17, 2019
Study Start
January 10, 2018
Primary Completion
April 30, 2019
Study Completion
April 30, 2019
Last Updated
October 17, 2019
Record last verified: 2019-10
Data Sharing
- IPD Sharing
- Will not share