Predictive Factors for a Successful Return to Run After A... | NCT04130308

Studies
Predictive Factors for a Successful Return to Run After ACL-R

NCT04130308

Sponsor

Laval University

Status

Completed

Last Update Posted

Oct 17, 2019Actual

Enrollment

72Actual

Phase

Not Applicable

Conditions

ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION

Interventions

Retrun to run protocol

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 10, 2018Actual

Primary Completion Date

Apr 30, 2019Actual

Completion Date

Apr 30, 2019Actual

First Submitted Date

Oct 11, 2019

First Submission Date that Met QC Criteria

Oct 15, 2019

First Posted Date

Oct 17, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 15, 2019

Last Update Posted Date

Oct 17, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jean-Sébastien Roy, Associate Professor, Faculty of Medicine, Laval UniversityPrincipal Investigator

Lead Sponsor

Laval UniversityOTHER

Collaborators

Name	Class
Ordre Professionnel de la Physiothérapie du Québec (OPPQ)	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

72Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ACL-R	Experimental		Other: Retrun to run protocol
Control	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Retrun to run protocol	Other	Progressive return to run protocol for patients after ACL-R	ACL-R

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Running kinematic	knee kinematic (degree)	Day 0 and Day 14
Running kinetic	kinetic (N)	Day 0 and Day 14

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jean-Sébastien Roy, PhD	Laval University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Center for Interdisciplinary Research in Rehabilitation and Social Integration (CIRRIS)		Québec	Quebec		Canada

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided