An observational study in ACL, sponsored by Sports Surgery Clinic, Santry, Dublin. Status unknown at 1 site in Ireland. Open to male participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-12-15.
Sponsored by Sports Surgery Clinic, Santry, Dublin · Observational
The anterior cruciate ligament (ACL) is thought to have two main roles within the body: (1) providing a physical restraint to excessive rotation and forwards translation within the knee and (2) providing sensory information to the sensorimotor cortex (contributes to motor planning and motor task execution). Therefore, an ACL injury is thought to be not just a physical injury but also one which affects an individual's ability to plan and execute motor tasks. It has been suggested in previous research that following an ACL injury and even post-ACL reconstruction, individuals may become reliant on the visual-motor system when planning and executing movements. Therefore, this study aims to compare an ACLR population against healthy controls to see if it is possible to identify those who may be visually-motor reliant by accessing movement control in the absence of vision
This study will compare a male ACLR cohort against matched healthy controls. The study population will be between 18-35 year old males who are competing multi-directional field sport. The ACLR cohort will be 7 months post-surgery. The main outcome measure will be time to stability during the stepdown task (from a 20cm step). The stepdown task will be completed first with their eyes open and then with their eyes closed, thereby allowing for the creation of an index reporting how time to stability changes following the obstruction of vision. Strength and lower limb power measures will be collected as potential confounding factors.
The testing battery that participants complete are:
3D biomechanical tests:
questionnaires:
Sports Surgery Clinic, Santry, Dublin is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients would be recruited from those undergoing an ACLR under the care of orthopaedic surgeons at the Sports Surgery Clinic (Dublin, Ireland). At present, patients attend the Sports Medicine Department at Sports Surgery Clinic for strength, power and 3D biomechanical analysis at 7 months post-operatively prior to their reviews with their surgeon
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Individuals who are 7 months post primary ACLR
Healthy uninjured individuals who are actively playing sport and have not sustained any knee injuries, ankle injuries or concussions.
Time to stability during stepdown task (eyes open versus eyes closed)
Participants will stepdown from a 20cm box and land on one leg. Participants will be advised to achieve stability as quickly as possible and then to remain in that position for 20 seconds. Participants will complete 3 trials on each leg first with their eyes open and then a further 3 trials on each leg whilst blindfolded. Participants will perform this test in the 3D lab utilising using an eight-camera motion analysis system (200Hz: Bonita-B10, Vicon, UK)
Time frame: at 7 months post-ACLR
Joint position sense testing
Participants will be seated and blindfolded. Participants will perform this test in the 3D lab utilising using an eight-camera motion analysis system (200Hz: Bonita-B10, Vicon, UK). The assessor will active extend the participant's knee to between 0-30 degrees and hold it there. The participant will then be asked to replicate that angle 5 times for each leg
Time frame: at 7 months post-ACLR
single leg balance (eyes closed versus eyes open)
Participants will perform this test in the 3D lab utilising using an eight-camera motion analysis system (200Hz: Bonita-B10, Vicon, UK) and integrated force plates (1000Hz BP400600, AMTI, USA). Participants will stand on one leg with less than 15 degrees knee flexion. They will be asked to balance for 20 seconds. 3 trials will be taken for each leg with participants' eyes open and 3 trials of each leg whilst they are blindfolded
Time frame: at 7 months post-ACLR
Quadriceps and hamstrings strength
isokinetic dynamometry conducted on each leg between 0-100 degrees at 60 deg/sec. 3 sets of 5 completed for each leg
Time frame: at 7 months post-ACLR
Countermovement jump- double leg and single leg
Participants will be instructed to jump as high as they can. This will be conducted 3 times with double leg and then 3 trials single legged (for each leg)
Time frame: at 7 months post-ACLR
Drop jump- double leg and single leg
participants will drop off 30cm step (double leg) and 15cm step (single leg) and be instructed to quickly jump off the ground and as high as they can. 3 trials of each will be taken
Time frame: at 7 months post-ACLR
anterior cruciate ligament return to sport after injury (ACL-RSI) questionnaire
Questionnaire utilised to assess for participants' readiness to return to sport and identify if there are any potential psychological factors impacting their return to sport. Minimum score 0% and maximum score 100%. Lower score indicates less fear regarding return to sport
Time frame: at 7 months post-ACLR
International knee documentation committee (IKDC) Questionnaire
Questionnaire utilised to assess participants' self-reported function. Minimum score 0 and maximum score 100. A higher score indicates higher levels of function
Time frame: at 7 months post-ACLR
Tampa scale of kinesiophobia
Questionnaire utilised to assess participants' fear of movement or reinjury. Minimum score 17 and maximum score 68. A lower score indicates better outcome or reduced kinesiophobia
Time frame: at 7 months post-ACLR
Near far quickness score (as part of visual processing software)
sensory tablet (Senaptec, USA) with preloaded assessment tasks to across multiple visual processing domains including near far quickness task. The task requires the participants to correctly answer a task on a screen 3 metres away. Upon entry of the correct answer, a task appears on a device 70-100cm from the participant. The task will then continue to move between the 2 screens over a 30 second period, with the number of correct responses and time taken to input a response being calculated. The number of correct responses over 30 second test period is reported with a higher score indicating better function
Time frame: at 7 months post-ACLR
Near far quickness reaction time to target (as part of visual processing software)
sensory tablet (Senaptec, USA) with preloaded assessment tasks to across multiple visual processing domains including near far quickness task. The task requires the participants to correctly answer a task on a screen 3 metres away. Upon entry of the correct answer, a task appears on a device 70-100cm from the participant. The task will then continue to move between the 2 screens over a 30 second period, with the number of correct responses and time taken to input a response being calculated. Average response time is calculated for individual to input correct response for a far target and a near target. A lower value indicates quicker reaction time and hence better function.
Time frame: at 7 months post-ACLR
Perception span (as part of visual processing software)
sensory tablet (Senaptec, USA) with preloaded assessment tasks to across multiple visual processing domains including perception span task. The task involves recalling which circles were filled following a pattern being flashed for 1 second. Total score is calculated by the software with a higher score indicating better function
Time frame: at 7 months post-ACLR
multiple object tracking score (as part of visual processing software)
sensory tablet (Senaptec, USA) with preloaded assessment tasks to across multiple visual processing domains including multiple object tracking task. In the task, a set of circles are highlighted to the participant. The circles then spin around the screen in conjunction with other circles before coming to a stop. The participant is then tasked with correctly identifying the circles that were initially highlighted.The software provides a proportional and composite score. A higher score indicates better function
Time frame: at 7 months post-ACLR
Reaction time (as part of visual processing software)
sensory tablet (Senaptec, USA) with preloaded assessment tasks to across multiple visual processing domains including reaction time task. In the task, the participant places both index fingers on the screen, a flashing red image indicates which finger needs to be removed from the screen. The participant is advised to remove their finger from the screen as quickly as possible. Reaction times are provided by the software for each side (dominant hand and non-dominant hand) and also as an average between the two sides. A lower time indicates better function
Time frame: at 7 months post-ACLR
This study is status unknown, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
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Sports Surgery Clinic, Santry, Dublin