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

NCT ID: NCT05374382

Last Updated: 2022-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-30

Study Completion Date

2024-09-30

Brief Summary

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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

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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).

Conditions

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ACL Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Strengthening

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

Group Type EXPERIMENTAL

Strengthening

Intervention Type BEHAVIORAL

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

Group Type ACTIVE_COMPARATOR

Conventional

Intervention Type BEHAVIORAL

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

Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Strengthening

3x/w, 9 wks supervised strengthening program, during prehabilitation to ACL surgery

Intervention Type BEHAVIORAL

Conventional

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Université de Nantes

OTHER

Sponsor Role lead

Responsible Party

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Guillaume Le Sant

Guillaume Le Sant, PhD,PT. Physiotherapist and Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Guillaume Le Sant, PhD, PT

Role: PRINCIPAL_INVESTIGATOR

Université de Nantes

Locations

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

Nantes, , France

Site Status

Countries

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France

Central Contacts

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Guillaume Le Sant, PhD, PT

Role: CONTACT

+251837234

Antoine Nordez, PhD

Role: CONTACT

+251837208

Facility Contacts

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Guillaume Le Sant, PT, PhD

Role: primary

+251837234

Other Identifiers

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ACL-Strong

Identifier Type: -

Identifier Source: org_study_id

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