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A Prehab Strengthening Program Prior to ACL Surgery on Lower Limb Structure and Function (ACL-Strong)

Primary Purpose

ACL Injury

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Strengthening
Conventional
Sponsored by
Université de Nantes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ACL Injury focused on measuring rehabilitation, strengthening, physiotherapy, atrophy

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • age : 18 to 55
  • first episode of ACL injury
  • having a planed ACL reconstruction
  • volunteer to participate

Exclusion Criteria:

  • age : <18 or >55
  • previous episode of ACL injury/reconstruction
  • no ACL reconstruction

Sites / Locations

  • Université de Nantes - MIP UR 4334 (Motricity, Movement, Interactions)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Strengthening

Conventional

Control

Arm Description

Participants received a 9-weeks strengthening-based prehabilitation program before ACL reconstruction, followed by a standardized post-operative rehabilitation program

Participants received a 9-weeks conventional prehabilitation program (targeting pain knee mobility) before ACL reconstruction, followed by a standardized post-operative rehabilitation program

No prehabilitation program Participants received only a standardized post-operative rehabilitation program

Outcomes

Primary Outcome Measures

Changes in muscle strength of the knee muscles
Maximal muscle strength of knee flexors/extensors will be assessed using isokinetic dynamometer, and extension and flexion torques during a maximum voluntary contraction (MVC). Unit : Newton meter (Nm)
Change in muscle volume of the knee muscles
Muscle volume of the knee muscles (hamstring and quadriceps) will be assessed using 3D ultrasound imaging, at rest in a prone (hamstring) or supined (quadriceps) position. Unit : millimeters (mL)
Change in the stiffness of knee muscles
An index of muscle stiffness will be assessed via the shear modulus using ultrasound shear wave elastography, at rest in a prone (hamstring) or supined (quadriceps) position. Unit : kiloPascals (kPa)
Change in lower limb function
Single leg hop test. Participants will be instructed to jump as far as possible on a single leg, without losing balance and landing firmly. The distance is measured from the start line to the heel of the landing leg. Unit : centimeters (cm)
Change in patient's opinion about the knee and associated problems
Patient's self-related opinion about symptoms and activity will be assessed using the International Knee Documentation Committee Subjective Knee Form (IKDC).The IKDC is consisted of 10 questions. Unit : score, scaled between 0 (=bad) and 100 (= good function)
Change in patient's opinion to return to sport
Patient's self-related opinion out the impact of returning to sport will be assessed using the Anterior Cruciate Ligament - Return to Sport after Injury (ACL-RSI) questionnaire. The ACL-RSI consists of 12 questions. Unit : score, scaled between 0 (=bad) and 100 (= more psychologically ready to return to sport)

Secondary Outcome Measures

Health consumption
Drugs intakes, dates of physiotherapy/medical consultations, date of return to work will be assessed through a diary Unit : self-reported date, in a paper diary

Full Information

First Posted
May 2, 2022
Last Updated
May 9, 2022
Sponsor
Université de Nantes
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1. Study Identification

Unique Protocol Identification Number
NCT05374382
Brief Title
A Prehab Strengthening Program Prior to ACL Surgery on Lower Limb Structure and Function
Acronym
ACL-Strong
Official Title
The Effects of a Lower Limb Strengthening Training Program During Prehabilitation Prior to ACL Surgery on Lower Limb Structure and Function : a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2022 (Anticipated)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Université de Nantes

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Atrophy and weakness are ubiquitous after a ACL rupture and associated with a worsened long-term recovery of individual capacities, despite surgery and rehabilitation. Preoperative rehabilitation (prehab) is believed to prepare patients for surgery and post-operative rehabilitation. However, prehab programs are highly variable, and do not always aim to develop/maintain neuromuscular parameters. The purpose of this study is to assess the effects of a lower limb strengthening training program during prehab prior to ACL Surgery on lower limb structure and function.
Detailed Description
Recruited participants will be randomly allocated to one of the three groups of participants constituted in this study. The two first groups will receive prehabilitation prior to ACL reconstruction (differing in program type). All participants will receive standardized post-surgery rehabilitation (based on international recommandations).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ACL Injury
Keywords
rehabilitation, strengthening, physiotherapy, atrophy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Strengthening
Arm Type
Experimental
Arm Description
Participants received a 9-weeks strengthening-based prehabilitation program before ACL reconstruction, followed by a standardized post-operative rehabilitation program
Arm Title
Conventional
Arm Type
Active Comparator
Arm Description
Participants received a 9-weeks conventional prehabilitation program (targeting pain knee mobility) before ACL reconstruction, followed by a standardized post-operative rehabilitation program
Arm Title
Control
Arm Type
No Intervention
Arm Description
No prehabilitation program Participants received only a standardized post-operative rehabilitation program
Intervention Type
Behavioral
Intervention Name(s)
Strengthening
Intervention Description
3x/w, 9 wks supervised strengthening program, during prehabilitation to ACL surgery
Intervention Type
Behavioral
Intervention Name(s)
Conventional
Intervention Description
Participants received a 9-weeks conventional prehabilitation program (targeting pain knee mobility) before ACL reconstruction, followed by a standardized post-operative rehabilitation program
Primary Outcome Measure Information:
Title
Changes in muscle strength of the knee muscles
Description
Maximal muscle strength of knee flexors/extensors will be assessed using isokinetic dynamometer, and extension and flexion torques during a maximum voluntary contraction (MVC). Unit : Newton meter (Nm)
Time Frame
week 0 (baseline); week 9 (post-intervention, short term) ; 6 months after the surgery (post-intervention, mid-term) and 12 months after the surgery (post-intervention, long-term)
Title
Change in muscle volume of the knee muscles
Description
Muscle volume of the knee muscles (hamstring and quadriceps) will be assessed using 3D ultrasound imaging, at rest in a prone (hamstring) or supined (quadriceps) position. Unit : millimeters (mL)
Time Frame
week 0 (baseline); week 9 (post-intervention, short term) ; 6 months after the surgery (post-intervention, mid-term) and 12 months after the surgery (post-intervention, long-term)
Title
Change in the stiffness of knee muscles
Description
An index of muscle stiffness will be assessed via the shear modulus using ultrasound shear wave elastography, at rest in a prone (hamstring) or supined (quadriceps) position. Unit : kiloPascals (kPa)
Time Frame
week 0 (baseline); week 9 (post-intervention, short term) ; 6 months after the surgery (post-intervention, mid-term) and 12 months after the surgery (post-intervention, long-term)
Title
Change in lower limb function
Description
Single leg hop test. Participants will be instructed to jump as far as possible on a single leg, without losing balance and landing firmly. The distance is measured from the start line to the heel of the landing leg. Unit : centimeters (cm)
Time Frame
week 0 (baseline); week 9 (post-intervention, short term) ; 6 months after the surgery (post-intervention, mid-term) and 12 months after the surgery (post-intervention, long-term)
Title
Change in patient's opinion about the knee and associated problems
Description
Patient's self-related opinion about symptoms and activity will be assessed using the International Knee Documentation Committee Subjective Knee Form (IKDC).The IKDC is consisted of 10 questions. Unit : score, scaled between 0 (=bad) and 100 (= good function)
Time Frame
week 0 (baseline); week 9 (post-intervention, short term) ; 6 months after the surgery (post-intervention, mid-term) and 12 months after the surgery (post-intervention, long-term)
Title
Change in patient's opinion to return to sport
Description
Patient's self-related opinion out the impact of returning to sport will be assessed using the Anterior Cruciate Ligament - Return to Sport after Injury (ACL-RSI) questionnaire. The ACL-RSI consists of 12 questions. Unit : score, scaled between 0 (=bad) and 100 (= more psychologically ready to return to sport)
Time Frame
week 0 (baseline); week 9 (post-intervention, short term) ; 6 months after the surgery (post-intervention, mid-term) and 12 months after the surgery (post-intervention, long-term)
Secondary Outcome Measure Information:
Title
Health consumption
Description
Drugs intakes, dates of physiotherapy/medical consultations, date of return to work will be assessed through a diary Unit : self-reported date, in a paper diary
Time Frame
week 0 (baseline); week 9 (post-intervention, short term) ; 6 months after the surgery (post-intervention, mid-term) and 12 months after the surgery (post-intervention, long-term)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age : 18 to 55 first episode of ACL injury having a planed ACL reconstruction volunteer to participate Exclusion Criteria: age : <18 or >55 previous episode of ACL injury/reconstruction no ACL reconstruction
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guillaume Le Sant, PhD, PT
Phone
+251837234
Email
guillaume.le-sant@univ-nantes.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Antoine Nordez, PhD
Phone
+251837208
Email
antoine.nordez@univ-nantes.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guillaume Le Sant, PhD, PT
Organizational Affiliation
Université de Nantes
Official's Role
Principal Investigator
Facility Information:
Facility Name
Université de Nantes - MIP UR 4334 (Motricity, Movement, Interactions)
City
Nantes
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guillaume Le Sant, PT, PhD
Phone
+251837234
Email
guillaume.le-sant@univ-nantes.fr
First Name & Middle Initial & Last Name & Degree
Lilian Lacourpaille, PhD
First Name & Middle Initial & Last Name & Degree
Antoine Nordez, PhD
First Name & Middle Initial & Last Name & Degree
Antoine Frouin, PhD st, PT

12. IPD Sharing Statement

Plan to Share IPD
No

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A Prehab Strengthening Program Prior to ACL Surgery on Lower Limb Structure and Function

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