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

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.

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04058574
Acronym
PRO-ACL
Enrollment
45
Registered
2019-08-15
Start date
2019-09-01
Completion date
2022-01-01
Last updated
2020-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ACL - Anterior Cruciate Ligament Deficiency, ACL Tear

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.

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.

Interventions

DEVICEProprioception measurement on isokinetic dynamometer

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

Sponsors

Institut National de la Santé Et de la Recherche Médicale, France
CollaboratorOTHER_GOV
University Hospital, Caen
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change from Baseline passive proprioceptive evaluation after 7 monthsACL 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 yearMeasurement of knee proprioception by the passive repositioning technique (JPS, in degrees) on isokinetic dynamometer.
Change from Baseline active proprioceptive evaluation after 7 monthsACL 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 yearMeasurement of knee proprioception by the active repositioning technique (JPS, in degrees) on isokinetic dynamometer.
Change from Baseline TDPM (Threshold to Detection of Passive Motion) evaluation after 7 monthsACL 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 yearMeasurement of knee proprioception by the Threshold to Detection of Passive Motion (TDPM in degrees) on isokinetic dynamometer.

Secondary

MeasureTime frameDescription
StrengthACL 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 yearMeasurement of knee extensors and flexors peak strength (in newton.meter, Nm) on isokinetic dynamometer.
ACL-RSI questionnaire (Anterior Cruciate Ligament-Return to Sport after Injury)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 surgeryThe ACL-RSI measures the patient's understanding of his knee. It comprises 12 questions with a score of 1 to 10 for each
Functional testingACL 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 yearHop 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)

Countries

France

Contacts

Primary ContactJoffrey DRIGNY, MD MSc
drigny-j@chu-caen.fr+332 31 06 45 33

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026