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

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ClinicalTrials.gov Identifier: NCT04058574
Recruitment Status : Not yet recruiting
First Posted : August 15, 2019
Last Update Posted : August 15, 2019
Sponsor:
Collaborator:
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by (Responsible Party):
Joffrey DRIGNY, University Hospital, Caen

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
ACL Tear ACL - Anterior Cruciate Ligament Deficiency Device: Proprioception measurement on isokinetic dynamometer Not Applicable

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Intervention Group "ACL": 30 patient, athletes, with ACL deficiency candidate to a surgical ACL reconstruction Control Group: 15 healthy volunteers, athletes.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Measurement and Relationships of Proprioceptive Isokinetic Repositioning With Muscle Strength, Functional Testing, and Self-reported Questionaires Before and After Anterior Cruciate Ligament Reconstruction: A Prospective Study With 12-months Post Operative Follow-up.
Estimated Study Start Date : September 1, 2019
Estimated Primary Completion Date : September 1, 2021
Estimated Study Completion Date : January 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: ACL
Intervention Group "ACL": 30 patient, athletes, with ACL deficiency candidate to a surgical ACL reconstruction
Device: Proprioception measurement on isokinetic dynamometer
Proprioception measurement on isokinetic dynamometer using joint position sense (JPS) and the threshold to detection of passive motion (TTDPM)

Placebo Comparator: Control
Control Group: 15 healthy volunteers, athletes.
Device: Proprioception measurement on isokinetic dynamometer
Proprioception measurement on isokinetic dynamometer using joint position sense (JPS) and the threshold to detection of passive motion (TTDPM)




Primary Outcome Measures :
  1. Change from Baseline passive proprioceptive evaluation after 7 months [ Time Frame: ACL group: 6 weeks after surgery and 7 months after surgery; Healthy group: one evaluation at a single point in time through study completion, an average of 1 year ]
    Measurement of knee proprioception by the passive repositioning technique (JPS, in degrees) on isokinetic dynamometer.

  2. Change from Baseline active proprioceptive evaluation after 7 months [ Time Frame: ACL group: 6 weeks after surgery and 7 months after surgery; Healthy group: one evaluation at a single point in time through study completion, an average of 1 year ]
    Measurement of knee proprioception by the active repositioning technique (JPS, in degrees) on isokinetic dynamometer.

  3. Change from Baseline TDPM (Threshold to Detection of Passive Motion) evaluation after 7 months [ Time Frame: ACL group: 6 weeks after surgery and 7 months after surgery; Healthy group: one evaluation at a single point in time through study completion, an average of 1 year ]
    Measurement of knee proprioception by the Threshold to Detection of Passive Motion (TDPM in degrees) on isokinetic dynamometer.


Secondary Outcome Measures :
  1. Strength [ Time Frame: ACL group: Two evaluations on both injured and healthy knees: (1) 3 months after surgery and (2) 7 months after surgery; Healthy group: one evaluation at a single point in time through study completion, an average of 1 year ]
    Measurement of knee extensors and flexors peak strength (in newton.meter, Nm) on isokinetic dynamometer.

  2. ACL-RSI questionnaire (Anterior Cruciate Ligament-Return to Sport after Injury) [ Time Frame: ACL group: Four evaluations on both injured and healthy knees: (1) 2 weeks before surgery, (2) 3 months after surgery, (3) 7 months after surgery and (4) 12 months after surgery ]
    The ACL-RSI measures the patient's understanding of his knee. It comprises 12 questions with a score of 1 to 10 for each

  3. Functional testing [ Time Frame: ACL group: Two evaluations on both injured and healthy knees: (1) 3 months after surgery and (2) 7 months after surgery; Healthy group: one evaluation at a single point in time through study completion, an average of 1 year ]

    Hop test. Single hop: Patients are instructed to stand on one leg and perform 1 jump as far as possible, landing on the same leg.

    The total distance is recorded (in cm) .Triple hop: Patients are instructed to stand on one leg and perform 3 hops as far as possible, landing on the same leg.

    The total distance for 3 consecutive hops is recorded (in cm). Cross-over hop test : The patient hops forward 3 times while alternately crossing over a marking The patient is instructed to position themselves such that the first of the 3 hops was lateral with respect to the direction of crossover The total distance hopped forward is recorded (in cm)




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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04058574


Locations
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France
Caen University Hospital
Caen, France
Sponsors and Collaborators
University Hospital, Caen
Institut National de la Santé Et de la Recherche Médicale, France

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Responsible Party: Joffrey DRIGNY, Chief Resident PM&R and Sport departments MD, MSc, University Hospital, Caen
ClinicalTrials.gov Identifier: NCT04058574     History of Changes
Other Study ID Numbers: PRO-ACL
First Posted: August 15, 2019    Key Record Dates
Last Update Posted: August 15, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anterior Cruciate Ligament Injuries
Knee Injuries
Leg Injuries
Wounds and Injuries