MedDataX Logo

What is the Effect of Vision on Movement Control in Anterior Cruciate Ligament Reconstructed Patients 7 Months Post-surgery?

NCT ID: NCT05121857

Last Updated: 2021-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-12-31

Study Completion Date

2022-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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:

1. double leg countermovement jump
2. single leg countermovement jump
3. double leg drop jump
4. single leg drop jump
5. stepdown test (eyes open and eyes closed)
6. joint position sense test
7. single leg balance (eyes open and eyes closed)
* isokinetic strength testing of quadriceps and hamstrings at 60deg/sec. 3 sets of 5
* questionnaires:

1. international knee documentation committee
2. tampa scale of kinesiophobia
3. ACL- return to sport after injury

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

ACL

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ACLR group

Individuals who are 7 months post primary ACLR

No interventions assigned to this group

healthy control group

Healthy uninjured individuals who are actively playing sport and have not sustained any knee injuries, ankle injuries or concussions.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Sports Surgery Clinic, Santry, Dublin

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Sports Surgery Clinic

Dublin, Leinster, Ireland

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Ireland

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Andy D Franklyn-Miller, MBBS

Role: CONTACT

Phone: 00 353 1 526 2030

Email: [email protected]

Enda A King, BSc, MSc

Role: CONTACT

Phone: 00 353 1 526 2030

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Andy D Franklyn-Miller, MBBS

Role: primary

Enda A King, BSc, MSc

Role: backup

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SSC-ACL-002

Identifier Type: -

Identifier Source: org_study_id