Anterior Cruciate Ligaments: Studying Updates in neuroCognition After Knee Manipulation

NCT ID: NCT07058467

Last Updated: 2025-09-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-01
• Study Completion Date: 2026-05-31

Brief Summary

This study will investigate whether knee joint manipulation can improve neurocognitive and neuromuscular performance in individuals with a history of anterior cruciate ligament reconstruction (ACLR). Recruitment will consist of 30 participants aged 18-35 who are 4 months to 5 years post-ACLR and demonstrate measurable reaction time delays. Using a within-subject pre-post design, participants will complete a battery of neurocognitive and neuromuscular assessments, including visuomotor reaction time and dual-task hop testing, before and after knee joint manipulation(s).

The main questions the investigators aim to address are:

Aim 1: Evaluate the feasibility, acceptability, and applicability of integrating knee joint manipulation into post-ACLR rehabilitation using the Implementation and Outcomes Framework.

Aim 2: Determine preliminary efficacy of knee joint manipulation on neurocognitive performance in individuals with ACLR.

Conditions

Anterior Cruciate Ligament (ACL) Tear; Anterior Cruciate Ligament Reconstruction Rehabilitation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Knee manipulation post ACLR

This group, which comprises the entire cohort, will receive knee joint manipulations coinciding with grade III+ measures.

Group Type: EXPERIMENTAL

Joint Manipulation

Intervention Type: OTHER

A joint manipulation is defined as a manual treatment by a clinician that uses controlled force to improve joint function. For the purpose of this study, the terms manipulation and mobilization may be used interchangeably. The knee joint is specifically defined as the tibiofemoral articulation for the purpose of this study.

All knee joint manipulation in this study will coincide with grade III or IV manipulations. This category coincides with evidence that mobilizations at or above grade III has the greatest impact on somatosensation and are most likely to produce a positive effect on neurocognitive function. Joint manipulation(s) will be delivered with a vector corresponding to the functional deficits found with manual joint palpation and will only occur with the involved ACLR knee. If both knees have experienced an ACL injury, the most recently injured knee will be manipulated.

Interventions

Joint Manipulation

A joint manipulation is defined as a manual treatment by a clinician that uses controlled force to improve joint function. For the purpose of this study, the terms manipulation and mobilization may be used interchangeably. The knee joint is specifically defined as the tibiofemoral articulation for the purpose of this study.

All knee joint manipulation in this study will coincide with grade III or IV manipulations. This category coincides with evidence that mobilizations at or above grade III has the greatest impact on somatosensation and are most likely to produce a positive effect on neurocognitive function. Joint manipulation(s) will be delivered with a vector corresponding to the functional deficits found with manual joint palpation and will only occur with the involved ACLR knee. If both knees have experienced an ACL injury, the most recently injured knee will be manipulated.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Provided informed consent prior to any study procedures that are performed.
• Are between the ages of 18 and 35.
• Have undergone ACLR surgery. All autograft and allograft types are accepted.
• Are 4-months to 10-years post-ACLR.
• Injured knee playing or training for sports (recreational or organized) or during physical activity.
• Have been cleared by a physician to return to activities and/or participate in this study.
• Are at least the minimally clinical important difference (MCID) above the normative reaction time average for our methods as established by previous literature in at least 1 reaction time task.

Exclusion Criteria

• History of concussion in the past 3 months.
• The participant is pregnant.
• Have a neurological disorder, including epilepsy.
• Currently injured or have injured their lower extremity in the past 3 months.
• Had surgery on multiple ligaments when their ACL was injured.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shelby Baez, PhD, ATC

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Gannon Brochin, DC, MS

Role: CONTACT

gannon_brochin@med.unc.edu

9193910314

Facility Contacts

Gannon Brochin, DC

Role: primary

gannon_brochin@med.unc.edu

9193910314

Other Identifiers

25-0824

Identifier Type: -

Identifier Source: org_study_id