NCT05141812

Brief Summary

The majority of anterior cruciate ligament (ACL) injuries occur during non-contact mechanisms.This suggests that an individual's movement technique is a significant factor in the cause of the injury. Hence, ACL injuries are increasingly being framed as an error in motor planning and execution. Rehab following an ACL reconstruction (ACLR) commonly follows a pathway of: regaining ROM, strength development, power development, running, return to training and then return to competition. However, several studies utilising functional brain MRI and electroencephalogram have demonstrated dysfunction within the somatosensory and visual systems in the ACLR population even after the completion of rehabilitation. This has been suggested to indicate that the ACLR population becomes reliant on their visual system during motor planning and execution, potentially increasing the risk of reinjury.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

November 3, 2021

Completed
28 days until next milestone

Study Start

First participant enrolled

December 1, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 2, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

December 2, 2021

Status Verified

November 1, 2021

Enrollment Period

8 months

First QC Date

November 3, 2021

Last Update Submit

November 30, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • change of direction biomechanics- planned versus unplanned

    Participants will perform 90 degree cut within a 3D lab utilising using an eight-camera motion analysis system (200Hz: Bonita-B10, Vicon, UK) and integrated force plates (1000Hz BP400600, AMTI, USA). Timing gates (Smartspeed, Fusion Sport) will be used to time the change of direction and also provide the participant a visual stimulus as to which direction they need to cut to. The lights will be on during planned change of direction and 3 trials will be taken for each direction. During the unplanned change of direction, the target timing gates (right or left) will only switch on 2 metres prior to the participants approaching the force plates. 3 trials will be taken in the unplanned condition

    at 7 months post-ACLR

  • 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)

    at 7 months post-ACLR

Secondary Outcomes (13)

  • Joint position sense test

    at 7 months post-ACLR

  • single leg balance (eyes open versus eyes closed)

    at 7 months post-ACLR

  • Quadriceps and hamstrings strength

    at 7 months post-ACLR

  • Countermovement jump- double and single leg

    at 7 months post-ACLR

  • Drop jump- double leg and single leg

    at 7 months post-ACLR

  • +8 more secondary outcomes

Study Arms (2)

ACLR group

ACLR participants would be 7 months post surgery

healthy control group

Healthy uninjured participants who are actively engaged in gaelic football or hurling.

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sports Surgery Clinic

Dublin, Leinster, Ireland

RECRUITING

Central Study Contacts

Andy D Franklyn-Miller, MBBS

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 2021

First Posted

December 2, 2021

Study Start

December 1, 2021

Primary Completion

August 1, 2022

Study Completion

December 1, 2022

Last Updated

December 2, 2021

Record last verified: 2021-11

Locations