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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04130308
Other study ID # ACLR/Running 2019
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 10, 2018
Est. completion date April 30, 2019

Study information

Verified date October 2019
Source Laval University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 72
Est. completion date April 30, 2019
Est. primary completion date April 30, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Experimental group

Inclusion Criteria:

- ACL-R 3 to 4 months ago

Exclusion Criteria:

- already returned to run

- multiple ligament lesions

Control group

Inclusion Criteria:

- healthy person

Exclusion Criteria:

- history of ACL lesion or reconstruction

- history of knee injury

- injured in the last year

Study Design


Related Conditions & MeSH terms

  • ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION

Intervention

Other:
Retrun to run protocol
Progressive return to run protocol for patients after ACL-R

Locations

Country Name City State
Canada Center for Interdisciplinary Research in Rehabilitation and Social Integration (CIRRIS) Quebec City Quebec

Sponsors (2)

Lead Sponsor Collaborator
Laval University Ordre Professionnel de la Physiothérapie du Québec (OPPQ)

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Muscular strength assessment Quadriceps, hamstring and gluteus strength assessment with handheld dynamometer (N) Day 0
Primary Modified Y-balance test Modified Y-balance test (m) Day 0
Primary step-down test endurance test, number of repetition Day 0
Primary Self-reported outcomes: ACL-RSI ACL-RSI: 0-100 Day 0
Primary Self-reported outcomes: IKDC IKDC: 0-100 Day 0
Secondary Running kinematic knee kinematic (degree) Day 0 and Day 14
Secondary Running kinetic kinetic (N) Day 0 and Day 14
Secondary Knee joint contact force knee joint contact force (N) Day 0 and Day 14
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