NCT04130308

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2019

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 11, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 17, 2019

Completed
Last Updated

October 17, 2019

Status Verified

October 1, 2019

Enrollment Period

1.3 years

First QC Date

October 11, 2019

Last Update Submit

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

EXPERIMENTAL
Other: Retrun to run protocol

Control

NO INTERVENTION

Interventions

Progressive return to run protocol for patients after ACL-R

ACL-R

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

Study Officials

  • Jean-Sébastien Roy, PhD

    Laval University

    PRINCIPAL INVESTIGATOR

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

Locations