Anterior Cruciate Ligaments: Studying Updates in neuroCognition After Knee Manipulation

NCT07058467 | Withdrawn

• 1 other identifier: 25-0824
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Keywords

ACL; Anterior Cruciate Ligament; ACLR; Neurocognition

Outcome Measures

Primary Outcomes (5)

• Change in Simple Reaction Time

  Simple reaction time is the amount of time it takes for a person to respond to a single, known stimulus with a predefined response (ms). It is a basic measure of neuromuscular and cognitive processing speed. This is collected with the Senaptec Sensory Station.

  Baseline and up to 90 minutes after completion of joint manipulation (intervention)

• Change in Lower Extremity Visuomotor Reaction Time

  Visuomotor reaction time refers to the time it takes for an individual to see a visual stimulus and then generate a coordinated motor response to it (ms). It combines two processes: visual perception and motor execution. This is collected with the Fitlight system.

  Baseline and up to 90 minutes after completion of joint manipulation (intervention)

• Mean Feasibility of Joint Manipulation Score

  Collected with the Feasibility of Intervention Measure (FIM). Feasibility refers to how practical and achievable a study or project is in terms of its design, implementation, and resources. The FIM consists of four questions on a 5-point Likert scale ranging from 1 (completely disagree) to 5 (completely agree). The total score the four questions (4-20) will be averaged across all participants. Higher scores indicate greater feasibility. In this study, only patient perception is evaluated.

  Baseline and up to 90 minutes after completion of joint manipulation (intervention)

• Mean Acceptability of Joint Manipulation Score

  Collected with the Acceptability of Intervention Measure (AIM). Acceptability refers to how well a study's intervention, procedures, or overall design are perceived and tolerated by participants, clinicians, or other stakeholders. The AIM consists of four questions on a 5-point Likert scale ranging from 1 (completely disagree) to 5 (completely agree). The total score the four questions (4-20) will be averaged across all participants. Higher scores indicate greater acceptability. In this study, only patient perception is evaluated.

  Baseline and up to 90 minutes after completion of joint manipulation (intervention)

• Mean Appropriateness of Joint Manipulation Score

  Collected with the Intervention Appropriateness Measure (IAM). Appropriateness refers to the extent to which an intervention, method, or study design is suitable for the specific context, population, or problem being addressed. The IAM consists of four questions on a 5-point Likert scale ranging from 1 (completely disagree) to 5 (completely agree). The total score the four questions (4-20) will be averaged across all participants. Higher scores indicate greater appropriateness. This will only take into account the patient's response.

  Baseline and up to 90 minutes after completion of joint manipulation (intervention)

Secondary Outcomes (6)

• Change in Mean Single Leg Hop Distance For Level 1 Neurocognitive Hop Test

  Baseline and up to 90 minutes after completion of joint manipulation (intervention)

• Change in Mean Reaction Time For Level 1 Neurocognitive Hop Test

  Baseline and up to 90 minutes after completion of joint manipulation (intervention)

• Change in Mean Single Leg Hop Distance For Level 2 Neurocognitive Hop Test

  Baseline and up to 90 minutes after completion of joint manipulation (intervention)

• Change in Mean Reaction Time For Level 2 Neurocognitive Hop Test

  Baseline and up to 90 minutes after completion of joint manipulation (intervention)

• Change in Mean Single Leg Hop Distance For Level 3 Neurocognitive Hop Test

  Baseline and up to 90 minutes after completion of joint manipulation (intervention)

Study Arms (1)

Knee manipulation post ACLR

EXPERIMENTAL

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

Other: Joint Manipulation

Interventions

Joint Manipulation 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.

Knee manipulation post ACLR

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Lacerations

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Shelby Baez, PhD, ATC

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single arm, pre-post cohort

Study Record Dates

• First Submitted: June 18, 2025
• First Posted: July 10, 2025
• Study Start: August 1, 2025
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 9 and continuing for 36 months following publication.
• Access Criteria: Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.

Locations

US (1)