Proprioceptive Isokinetic Repositioning, Functional Testing, and a Self-reported Questionnaire Before and After Anterior Cruciate Ligament Reconstruction
PRO-ACL
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.
1 other identifier
interventional
45
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2019
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 9, 2019
CompletedFirst Posted
Study publicly available on registry
August 15, 2019
CompletedStudy Start
First participant enrolled
September 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2022
CompletedJuly 15, 2020
July 1, 2020
2 years
August 9, 2019
July 13, 2020
Conditions
Outcome Measures
Primary Outcomes (3)
Change from Baseline passive proprioceptive evaluation after 7 months
Measurement of knee proprioception by the passive repositioning technique (JPS, in degrees) on isokinetic dynamometer.
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
Change from Baseline active proprioceptive evaluation after 7 months
Measurement of knee proprioception by the active repositioning technique (JPS, in degrees) on isokinetic dynamometer.
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
Change from Baseline TDPM (Threshold to Detection of Passive Motion) evaluation after 7 months
Measurement of knee proprioception by the Threshold to Detection of Passive Motion (TDPM in degrees) on isokinetic dynamometer.
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
Secondary Outcomes (3)
Strength
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
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 surgery
Functional testing
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
Study Arms (2)
ACL
ACTIVE COMPARATORIntervention Group "ACL": 30 patient, athletes, with ACL deficiency candidate to a surgical ACL reconstruction
Control
PLACEBO COMPARATORControl Group: 15 healthy volunteers, athletes.
Interventions
Proprioception measurement on isokinetic dynamometer using joint position sense (JPS) and the threshold to detection of passive motion (TTDPM)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Caen University Hospital
Caen, France
Caen University Hospital
Caen, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief Resident PM&R and Sport departments MD, MSc
Study Record Dates
First Submitted
August 9, 2019
First Posted
August 15, 2019
Study Start
September 1, 2019
Primary Completion
September 1, 2021
Study Completion
January 1, 2022
Last Updated
July 15, 2020
Record last verified: 2020-07