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

ACL Injury Clinical Trial

— 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05374382
• Other study ID #: ACL-Strong
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2022
• Est. completion date: September 2024

Study information

• Verified date: May 2022
• Source: Université de Nantes
• Contact: Guillaume Le Sant, PhD, PT
• Phone: +251837234
• Email: guillaume.le-sant[@]univ-nantes.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 75
• Est. completion date: September 2024
• Est. primary completion date: September 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• ACL Injury
• Anterior Cruciate Ligament Injuries

Intervention

Behavioral:
• Strengthening
3x/w, 9 wks supervised strengthening program, during prehabilitation to ACL surgery
• Conventional
Participants received a 9-weeks conventional prehabilitation program (targeting pain knee mobility) before ACL reconstruction, followed by a standardized post-operative rehabilitation program

Locations

Country	Name	City	State
France	Université de Nantes - MIP UR 4334 (Motricity, Movement, Interactions)	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Université de Nantes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	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)
Primary	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)	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)
Primary	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)	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)
Primary	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)	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)
Primary	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)	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)
Primary	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)	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	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	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)