ACLNCT05121857
What is the Effect of Vision on Movement Control in Anterior Cruciate Ligament Reconstructed Patients 7 Months Post-surgery?
An observational study of ACL, run by Sports Surgery Clinic, Santry, Dublin at 1 site in Ireland.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- ACL
- How many people
- 90 participants
- Where
- 1 siteIreland
- Study dates
- Dec 2021to Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: 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
Who may be able to join
- Aged 18-35 years old
- Playing club level Gaelic football or hurling
- They must report that they intend on returning to sport at the same or higher level
- Able to give written informed consent and to participate fully in the interventions
- At 7 months biomechanical testing, individuals would need to have 70% symmetry of both quadriceps and hamstring peak torque as measured on our isokinetic dynamometer with the angular velocity set to 60°/s
- Individuals should have already commenced linear running and double leg jumping tasks as part of their rehabilitation
- They are currently attending a gym or can attain gym access for the duration of intervention period
Who cannot join
- They have not commenced running or jumping in their rehabilitation
- Revision ACL
- They underwent concurrent meniscal repair, chondral repair or extra-articular augmentation
- Serious medical conditions preventing them from completing high intensity resistance exercise
- Any previous: injuries to the visual system, concussion, head injury, unexplained seizures or epilepsy
- Any previous ankle or knee injuries
- Those who are uncomfortable or do not want to hop with their eyes closed (one of the assessment tasks will involve hopping on one leg with their eyes open and followed by another set in which their eyes are closed
Trial locations and contacts
1 site in 1 country.
Ireland1 site, 1 recruiting
- Recruiting
Sports Surgery Clinic
Dublin, Leinster
Andy D Franklyn-Miller, MBBS, 00 353 1 526 2030, afranklynmiller@me.com
Enda A King, BSc, MSc, 00 353 1 526 2030, endaking@sportssurgeryclinic.com
About this study
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
Read the detailed description
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:
- visual processing ability via a sensory station which contains neurocognitive and visual acuity testing
- 3D biomechanical tests:
- double leg countermovement jump
- single leg countermovement jump
- double leg drop jump
- single leg drop jump
- stepdown test (eyes open and eyes closed)
- joint position sense test
- single leg balance (eyes open and eyes closed)
- isokinetic strength testing of quadriceps and hamstrings at 60deg/sec. 3 sets of 5
- questionnaires:
- international knee documentation committee
- tampa scale of kinesiophobia
- ACL- return to sport after injury
- Conditions
- ACL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ACLR group | Individuals who are 7 months post primary ACLR | |
| healthy control group | Healthy uninjured individuals who are actively playing sport and have not sustained any knee injuries, ankle injuries or concussions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: at 7 months post-ACLR
Secondary outcomes (13)
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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: at 7 months post-ACLR
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2021
- Study startDec 2021 (estimated)
- Primary completionSep 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ACLStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sports Surgery Clinic, Santry, Dublin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05121857
- Sponsor's protocol ID
- SSC-ACL-002
- Status last verified
- Nov 2021
- First submitted
- 3 Nov 2021
- Last updated
- 15 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- What is the Effect of Vision on Movement Control in Anterior Cruciate Ligament Reconstructed Patients 7 Months Post-surgery?
- ClinicalTrials.gov ID
- NCT05121857
- Acronym / sponsor ID
- SSC-ACL-002
- Conditions
- ACL
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Sports Surgery Clinic, Santry, DublinUniversity, hospital or other
- Study start
- Dec 2021 (estimated)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 16 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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:
- visual processing ability via a sensory station which contains neurocognitive and visual acuity testing
- 3D biomechanical tests:
- double leg countermovement jump
- single leg countermovement jump
- double leg drop jump
- single leg drop jump
- stepdown test (eyes open and eyes closed)
- joint position sense test
- single leg balance (eyes open and eyes closed)
- isokinetic strength testing of quadriceps and hamstrings at 60deg/sec. 3 sets of 5
- questionnaires:
- international knee documentation committee
- tampa scale of kinesiophobia
- ACL- return to sport after injury
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACLR group | – | –Individuals who are 7 months post primary ACLR |
| healthy control group | – | –Healthy uninjured individuals who are actively playing sport and have not sustained any knee injuries, ankle injuries or concussions. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 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
Key inclusion criteria (7 listed)
- Aged 18-35 years old
- Playing club level Gaelic football or hurling
- They must report that they intend on returning to sport at the same or higher level
- Able to give written informed consent and to participate fully in the interventions
- At 7 months biomechanical testing, individuals would need to have 70% symmetry of both quadriceps and hamstring peak torque as measured on our isokinetic dynamometer with the angular velocity set to 60°/s
Key exclusion criteria (7 listed)
- They have not commenced running or jumping in their rehabilitation
- Revision ACL
- They underwent concurrent meniscal repair, chondral repair or extra-articular augmentation
- Serious medical conditions preventing them from completing high intensity resistance exercise
- Any previous: injuries to the visual system, concussion, head injury, unexplained seizures or epilepsy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Time to stability during stepdown task (eyes open versus eyes closed)
Time frame: at 7 months post-ACLR
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)
13 secondary outcomes
Joint position sense testing
Time frame: at 7 months post-ACLR
single leg balance (eyes closed versus eyes open)
Time frame: at 7 months post-ACLR
Quadriceps and hamstrings strength
Time frame: at 7 months post-ACLR
Countermovement jump- double leg and single leg
Time frame: at 7 months post-ACLR
Drop jump- double leg and single leg
Time frame: at 7 months post-ACLR
anterior cruciate ligament return to sport after injury (ACL-RSI) questionnaire
Time frame: at 7 months post-ACLR
International knee documentation committee (IKDC) Questionnaire
Time frame: at 7 months post-ACLR
Tampa scale of kinesiophobia
Time frame: at 7 months post-ACLR
Near far quickness score (as part of visual processing software)
Time frame: at 7 months post-ACLR
Near far quickness reaction time to target (as part of visual processing software)
Time frame: at 7 months post-ACLR
Perception span (as part of visual processing software)
Time frame: at 7 months post-ACLR
multiple object tracking score (as part of visual processing software)
Time frame: at 7 months post-ACLR
Reaction time (as part of visual processing software)
Time frame: at 7 months post-ACLR
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ACL, run by Sports Surgery Clinic, Santry, Dublin at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andy D Franklyn-Miller, MBBS (00 353 1 526 2030, afranklynmiller@me.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to stability during stepdown task (eyes open versus eyes closed) (time frame: at 7 months post-ACLR). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2021.