Proprioceptive Isokinetic Repositioning, Functional Testing, and a Self-reported Questionnaire Before and After Anterior Cruciate Ligament Reconstruction

NCT ID: NCT04058574

Last Updated: 2020-07-15

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

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-01

Study Completion Date

2022-01-01

Brief Summary

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This prospectively study aims to evaluate the evolution of knee joint proprioception on isokinetic dynamometer before and after Anterior Cruciate Ligament (ACL) reconstruction and its relationships with muscle strength, self reported questionnaire and return to sport. This study will include 30 athletes with isolated ACL rupture, and treated with ACL reconstruction surgery and 15 healthy volunteers.

Detailed Description

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Anterior cruciate ligament (ACL) rupture is a common injury in athletes. It has multiple consequences on the knee: instability, pain, loss of muscle strength, proprioceptive impairments, modification of the knee kinematics and premature knee osteoarthritis. In athletes, the majority of these injuries are treated with ACL reconstruction surgery. The main objective of this treatment is the reduction of knee instability to allow return to sport, and this at the same level prior to the injury. Thus, the athlete's follow-up after the surgery is essential to guide the return to sport and to ensure that the knee sensorimotor control allows the return to sport. Currently this assessment is based primarily on functional testings and measurement of muscle strength.

The investigators propose to prospectively study the evolution of instrumentally measured knee proprioception using isokinetic dynamometer before and after ACL reconstruction as well as a study of the factors associated with its favorable evolution and its impact in the return to sport and its level.

Conditions

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ACL Tear ACL - Anterior Cruciate Ligament Deficiency

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Intervention Group "ACL": 30 patient, athletes, with ACL deficiency candidate to a surgical ACL reconstruction Control Group: 15 healthy volunteers, athletes.
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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ACL

Intervention Group "ACL": 30 patient, athletes, with ACL deficiency candidate to a surgical ACL reconstruction

Group Type ACTIVE_COMPARATOR

Proprioception measurement on isokinetic dynamometer

Intervention Type DEVICE

Proprioception measurement on isokinetic dynamometer using joint position sense (JPS) and the threshold to detection of passive motion (TTDPM)

Control

Control Group: 15 healthy volunteers, athletes.

Group Type PLACEBO_COMPARATOR

Proprioception measurement on isokinetic dynamometer

Intervention Type DEVICE

Proprioception measurement on isokinetic dynamometer using joint position sense (JPS) and the threshold to detection of passive motion (TTDPM)

Interventions

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Proprioception measurement on isokinetic dynamometer

Proprioception measurement on isokinetic dynamometer using joint position sense (JPS) and the threshold to detection of passive motion (TTDPM)

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Isolated and primary tear of the ACL
* Individual candidate for an ACL reconstruction surgery.
* Acute ACL injury (\<6 weeks)
* Athletes (person who competes in one or more sports that involve physical strength, speed or endurance) whatever their level of sport practice
* Internet access

Exclusion Criteria

* Prior knee surgery
* Complex ligamentous lesion (lateral ligaments, posterior cruciate ligament)
* Surgery for meniscal lesions (patients initially included but warranting meniscal surgery during arthroscopy will be secondarily excluded from the study.)
* Recent muscle damage
* History of significant injury on the healthy knee
* ACL rupture recurrence
* Pregnant woman
* Neurological or vestibular antecedent with sequelae
* Individuals taking treatment altering alertness (neuroleptics, sedatives)
* Informed consent not obtained
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role collaborator

University Hospital, Caen

OTHER

Sponsor Role lead

Responsible Party

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Joffrey DRIGNY

Chief Resident PM&R and Sport departments MD, MSc

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Caen University Hospital

Caen, , France

Site Status RECRUITING

Caen University Hospital

Caen, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Joffrey DRIGNY, MD MSc

Role: CONTACT

+332 31 06 45 33

Facility Contacts

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Joffrey DRIGNY, MD MSc

Role: primary

Joffrey Drigny, MD MSc

Role: primary

+33231064533

Other Identifiers

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PRO-ACL

Identifier Type: -

Identifier Source: org_study_id

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