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.
Sponsor study identifier
interventional
45
1 country
2
Study Start
September 1, 2019
Actual (reported)Primary Completion
September 1, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
January 1, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 1, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 9, 2019
Actual (reported)August 15, 2019
Actual (reported)September 1, 2019
Actual (reported)September 1, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
January 1, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
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
Intervention Group "ACL": 30 patient, athletes, with ACL deficiency candidate to a surgical ACL reconstruction
Control Group: 15 healthy volunteers, athletes.
Proprioception measurement on isokinetic dynamometer using joint position sense (JPS) and the threshold to detection of passive motion (TTDPM)
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Caen University Hospital
Caen, France
Caen University Hospital
Caen, France
First Submitted
August 9, 2019
First Posted
August 15, 2019
Study Start
September 1, 2019
Actual (reported)Personalized Blood Flow Restriction for Anterior Cruciate Ligament Rehabilitation
Contact the study team to confirm eligibility.
Primary Completion
September 1, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
January 1, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
July 15, 2020
Record last verified: 2020-07
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Source: ClinicalTrials.gov.
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