search
Back to results

Efficacy of Preoperative Re-education on Patients With an Anterior Cruciate Ligament Rupture (PRELIG)

Primary Purpose

Anterior Cruciate Ligament Rupture

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Preoperative re-education
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anterior Cruciate Ligament Rupture focused on measuring Anterior cruciate ligament rupture, Preoperative re-education, Knee functional performance, Anterior cruciate ligament surgery, Single-leg hop for distance test performance

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients between 18 and 45 years old
  • Tegner physical activity level between 3 and 9
  • Primary and unilateral rupture of anterior cruciate ligament, confirmed by MRI
  • patient available to carry out the preoperative re-education program

Exclusion Criteria:

  • Complex lesion that would impede on preoperative re-education (posterior cruciate ligament, meniscal or chondral symptomatic lesion, fracture)/
  • Neurologic or cardiorespiratory pathology contra-indicating preoperative re-education
  • Previous surgical treatment of the lower limbs or of the lumbar spine
  • Neuropathic or algodystrophic pain on the lower limbs

Sites / Locations

  • CHU Clermont-FerrandRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

EXPERIMENTAL GROUP

CONTRL GROUP

Arm Description

Sessions are aiming to neuromuscular and functional training. Each session starts with trunk muscle activation. Patients will then have to realize a neuromuscular training on Huber Motion Lab® followed by multiple exercises targeting functional stability and neuromuscular control. From the 4th session, a jump sequence will be added to the previous exercices. Exercises used in this protocol are based upon successful exercises of protocols already performed on patients with anterior cruciate ligament rupture.

a control group (without preoperative reeducation)

Outcomes

Primary Outcome Measures

Functional performance as assessed by single-leg hop for distance test performance

Secondary Outcome Measures

Ability to return to high level athletics as assessed by single-leg hop for distance test performance
Assessment for both control and experimental group : inclusion (V0) preoperative visit (V1), 4-month follow-up (V4M) and 7-month follow-up (V7M)
Dynamic balance as assessed by star excursion balance test
Assessment for both control and experimental group : inclusion (V0) preoperative visit (V1), 4-month follow-up (V4M) and 7-month follow-up (V7M)
Quadriceps muscular strength as assessed by isokinetic test of quadriceps muscular strength
Assessment for both control and experimental group : inclusion (V0) preoperative visit (V1), 4-month follow-up (V4M) and 7-month follow-up (V7M)
Proprioception as assessed by repositioning knee test
Assessment for both control and experimental group : inclusion (V0) preoperative visit (V1), 4-month follow-up (V4M) and 7-month follow-up (V7M)
Knee anterior stability as assessed by KT-1000
Assessment for both control and experimental group : inclusion (V0) preoperative visit (V1), 4-month follow-up (V4M) and 7-month follow-up (V7M)
Subjective knee evaluation as assessed by International Knee Documentation committee 2000 questionnaire
Assessment for both control and experimental group : inclusion (V0) preoperative visit (V1), 4-month follow-up (V4M) and 7-month follow-up (V7M)
Knee symptoms as assessed by Lysholme questionnaire
Assessment for both control and experimental group : inclusion (V0) preoperative visit (V1), 4-month follow-up (V4M) and 7-month follow-up (V7M)
Physical activity level as assessed by Tegner knee scoring
Assessment for both control and experimental group : inclusion (V0) preoperative visit (V1), 4-month follow-up (V4M) and 7-month follow-up (V7M)

Full Information

First Posted
June 26, 2015
Last Updated
July 28, 2016
Sponsor
University Hospital, Clermont-Ferrand
search

1. Study Identification

Unique Protocol Identification Number
NCT02505659
Brief Title
Efficacy of Preoperative Re-education on Patients With an Anterior Cruciate Ligament Rupture
Acronym
PRELIG
Official Title
Efficacy of Preoperative Re-education on Patients With an Anterior Cruciate Ligament Rupture: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Unknown status
Study Start Date
February 2015 (undefined)
Primary Completion Date
September 2016 (Anticipated)
Study Completion Date
January 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand

4. Oversight

5. Study Description

Brief Summary
Anterior cruciate ligament (ACR) rupture is a common lesion of sportsmen that leads to functional deficits which are difficult to overcome. To prevent from an unfavorable evolution, patients can either get a non-surgical treatment or an ACR surgery, which is very common. Knee functional performance level could impact on the postoperative outcome and it's of common knowledge that early re-education after an ACR rupture improves knee functioning. Patients with an ACR rupture enrolled in this study will be randomized either in an experimental group (with preoperative reeducation) or in a control group (without preoperative reeducation). Both groups will then have post-operative re-education (40 sessions) based on HAS recommendations. The main aim of this study is to assess the impact of preoperative re-education on knee functional performance 4 month after surgical reconstruction of an ACR. Secondary aims are to determine the impact of the 4-week preoperative re-education on knee functional performance after an ACR rupture, before surgery and 7 months after surgery. Functional performance, muscular strength, proprioception and anterior knee laxity will be measured at inclusion (V0), 4-5 days before surgery (V1), 4 month (V4M) and 7 months (V7M) after surgery. Lysholme-Tegner scoring and IKDC2000 questionnaire will be added to the previous assessments.
Detailed Description
Anterior cruciate ligament (ACR) rupture is a common lesion of sportsmen that leads to functional deficits which are difficult to overcome. To prevent from an unfavorable evolution, patients can either get a non-surgical treatment or an ACR surgery, which is very common. Knee functional performance level could impact on the postoperative outcome and it's of common knowledge that early re-education after an ACR rupture improves knee functioning. Patients with an ACR rupture enrolled in this study will be randomized either in an experimental group (with preoperative reeducation) or in a control group (without preoperative reeducation). Both groups will then have post-operative re-education (40 sessions) based on HAS recommendations. The main aim of this study is to assess the impact of preoperative re-education on knee functional performance 4 month after surgical reconstruction of an ACR. Secondary aims are to determine the impact of the 4-week preoperative re-education on knee functional performance after an ACR rupture, before surgery and 7 months after surgery. Functional performance, muscular strength, proprioception and anterior knee laxity will be measured at inclusion (V0), 4-5 days before surgery (V1), 4 month (V4M) and 7 months (V7M) after surgery. Lysholme-Tegner scoring and IKDC2000 questionnaire will be added to the previous assessments.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Cruciate Ligament Rupture
Keywords
Anterior cruciate ligament rupture, Preoperative re-education, Knee functional performance, Anterior cruciate ligament surgery, Single-leg hop for distance test performance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
EXPERIMENTAL GROUP
Arm Type
Experimental
Arm Description
Sessions are aiming to neuromuscular and functional training. Each session starts with trunk muscle activation. Patients will then have to realize a neuromuscular training on Huber Motion Lab® followed by multiple exercises targeting functional stability and neuromuscular control. From the 4th session, a jump sequence will be added to the previous exercices. Exercises used in this protocol are based upon successful exercises of protocols already performed on patients with anterior cruciate ligament rupture.
Arm Title
CONTRL GROUP
Arm Type
No Intervention
Arm Description
a control group (without preoperative reeducation)
Intervention Type
Behavioral
Intervention Name(s)
Preoperative re-education
Intervention Description
Preoperative re-education (behavior): 8 re-education sessions of 30 to 40 minutes, 2 times a week, for 4 weeks
Primary Outcome Measure Information:
Title
Functional performance as assessed by single-leg hop for distance test performance
Time Frame
at 4 months after ACR surgery.
Secondary Outcome Measure Information:
Title
Ability to return to high level athletics as assessed by single-leg hop for distance test performance
Description
Assessment for both control and experimental group : inclusion (V0) preoperative visit (V1), 4-month follow-up (V4M) and 7-month follow-up (V7M)
Time Frame
at 4-month follow-up and 7-month follow-up compared to the initial visit and control group for:
Title
Dynamic balance as assessed by star excursion balance test
Description
Assessment for both control and experimental group : inclusion (V0) preoperative visit (V1), 4-month follow-up (V4M) and 7-month follow-up (V7M)
Time Frame
at 4-month follow-up and 7-month follow-up compared to the initial visit and control group for:
Title
Quadriceps muscular strength as assessed by isokinetic test of quadriceps muscular strength
Description
Assessment for both control and experimental group : inclusion (V0) preoperative visit (V1), 4-month follow-up (V4M) and 7-month follow-up (V7M)
Time Frame
at 4-month follow-up and 7-month follow-up compared to the initial visit and control group for:
Title
Proprioception as assessed by repositioning knee test
Description
Assessment for both control and experimental group : inclusion (V0) preoperative visit (V1), 4-month follow-up (V4M) and 7-month follow-up (V7M)
Time Frame
at 4-month follow-up and 7-month follow-up compared to the initial visit and control group for:
Title
Knee anterior stability as assessed by KT-1000
Description
Assessment for both control and experimental group : inclusion (V0) preoperative visit (V1), 4-month follow-up (V4M) and 7-month follow-up (V7M)
Time Frame
at 4-month follow-up and 7-month follow-up compared to the initial visit and control group for
Title
Subjective knee evaluation as assessed by International Knee Documentation committee 2000 questionnaire
Description
Assessment for both control and experimental group : inclusion (V0) preoperative visit (V1), 4-month follow-up (V4M) and 7-month follow-up (V7M)
Time Frame
at 4-month follow-up and 7-month follow-up compared to the initial visit and control group for
Title
Knee symptoms as assessed by Lysholme questionnaire
Description
Assessment for both control and experimental group : inclusion (V0) preoperative visit (V1), 4-month follow-up (V4M) and 7-month follow-up (V7M)
Time Frame
at 4-month follow-up and 7-month follow-up compared to the initial visit and control group for
Title
Physical activity level as assessed by Tegner knee scoring
Description
Assessment for both control and experimental group : inclusion (V0) preoperative visit (V1), 4-month follow-up (V4M) and 7-month follow-up (V7M)
Time Frame
at 4-month follow-up and 7-month follow-up compared to the initial visit and control group for

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients between 18 and 45 years old Tegner physical activity level between 3 and 9 Primary and unilateral rupture of anterior cruciate ligament, confirmed by MRI patient available to carry out the preoperative re-education program Exclusion Criteria: Complex lesion that would impede on preoperative re-education (posterior cruciate ligament, meniscal or chondral symptomatic lesion, fracture)/ Neurologic or cardiorespiratory pathology contra-indicating preoperative re-education Previous surgical treatment of the lower limbs or of the lumbar spine Neuropathic or algodystrophic pain on the lower limbs
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patrick LACARIN
Phone
04 73 75 11 95
Email
placarin@chu-clermontferrand.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aurore CHABAUD
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick LACARIN
Phone
04 73 75 11 95
Email
placarin@chu-clermontferrand.fr
First Name & Middle Initial & Last Name & Degree
Aurore CHABAUD

12. IPD Sharing Statement

Learn more about this trial

Efficacy of Preoperative Re-education on Patients With an Anterior Cruciate Ligament Rupture

We'll reach out to this number within 24 hrs