Anterior Cruciate Ligaments: Studying Updates in neuroCognition After Knee Manipulation

Not Applicable

Not yet recruiting

• Conditions: Anterior Cruciate Ligament (ACL) Tear; Anterior Cruciate Ligament Reconstruction Rehabilitation

• Registration Number: NCT07058467
• Lead Sponsor: University of North Carolina, Chapel Hill

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-18
• Study First Submitted QC: 2025-06-30
• Last Update Submitted: 2025-06-30
• Study First Posted: 2025-07-10
• Last Update Posted: 2025-07-10
• Study Start: 2025-08-01
• Primary Completion: 2026-05-31
• Study Completion: 2026-05-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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 5-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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in Simple Reaction Time	Baseline and up to 90 minutes after completion of joint manipulation (intervention)	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.
Change in Lower Extremity Visuomotor Reaction Time	Baseline and up to 90 minutes after completion of joint manipulation (intervention)	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.
Mean Feasibility of Joint Manipulation Score	Baseline and up to 90 minutes after completion of joint manipulation (intervention)	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.
Mean Acceptability of Joint Manipulation Score	Baseline and up to 90 minutes after completion of joint manipulation (intervention)	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.
Mean Appropriateness of Joint Manipulation Score	Baseline and up to 90 minutes after completion of joint manipulation (intervention)	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.

Secondary Outcome Measures

Name	Time	Method
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)	Single leg hop distance (m) will be collected and averaged during three trials on both legs. The level 1 neurocognitive hop test consists of a Fitlight placed 3 meters directly in front of the participant to indicate when to jump and another light at the participant's feet. The Fitlight at the feet is used to measure the reaction time needed to jump once the "go" light activates. The target light will change colors in the order of red, yellow, then green and then the target "go" color. Once the participant lands, the distance hopped will be recorded.
Change in Mean Reaction Time For Level 1 Neurocognitive Hop Test	Baseline and up to 90 minutes after completion of joint manipulation (intervention)	Single leg hop distance (m) will be collected and averaged during three trials on both legs. The level 1 neurocognitive hop test consists of a Fitlight placed 3 meters directly in front of the participant to indicate when to jump and another light at the participant's feet. The Fitlight at the feet is used to measure the reaction time needed to jump once the "go" light activates. The target light will change colors in the order of red, yellow, then green and then the target "go" color. Once the participant lands, the distance hopped will be recorded.
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)	Single leg hop distance (m) will be collected and averaged during three trials on both legs. The level 2 neurocognitive hop test consists of Fitlights placed 3m directly in front and 45 degrees off center of the participant as the target lights. A Fitlight will also be placed at the participant's feet to measure reaction time off the start position. The left, center, or right light will be selected first via a counterbalancing method as the targeted light. The participant is not told which light will be the target light. The left Fitlight will change colors in the order of red, yellow, then green and then the target "go" color. Once the participant lands, the distance hopped will be recorded. All three directions (left, center, and right) are tested for each leg.
Change in Mean Reaction Time For Level 2 Neurocognitive Hop Test	Baseline and up to 90 minutes after completion of joint manipulation (intervention)	Single leg hop distance (m) will be collected and averaged during three trials on both legs. The level 2 neurocognitive hop test consists of Fitlights placed 3m directly in front and 45 degrees off center of the participant as the target lights. A Fitlight will also be placed at the participant's feet to measure reaction time off the start position. The left, center, or right light will be selected first via a counterbalancing method as the targeted light. The participant is not told which light will be the target light. The left Fitlight will change colors in the order of red, yellow, then green and then the target "go" color. Once the participant lands, the distance hopped will be recorded. All three directions (left, center, and right) are tested for each leg.
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)	Single leg hop distance (m) will be collected and averaged during three trials on both legs. The level 3 neurocognitive hop test consists of Fitlights placed 3m directly in front and 45 degrees off center of the participant as the target lights. For the level 3 test, a built in wait time with "no-go" colors flashing each second will be used. The wait time will be either 3, 4, or 5 seconds and is selected via counterbalancing without notifying the participant. The left Fitlight will change colors in the order of red, yellow, then green. Once the trial has started, the lights will flash different "no-go" colors once per second until the determined wait time has elapsed. One randomly selected light will change to the "go" color while the other lights will be a highly contrasted "no-go" color. Once the participant lands, the distance hopped will be recorded. All three added wait times are tested for each leg.
Change in Mean Reaction Time For Level 3 Neurocognitive Hop Test	Baseline and up to 90 minutes after completion of joint manipulation (intervention)	Single leg hop distance (m) will be collected and averaged during three trials on both legs. The level 3 neurocognitive hop test consists of Fitlights placed 3m directly in front and 45 degrees off center of the participant as the target lights. A Fitlight will also be placed at the participant's feet to measure reaction time off the start position. For the level 3 test, a built in wait time with "no-go" colors flashing each second will be used. The wait time will be either 3, 4, or 5 seconds and is selected via counterbalancing without notifying the participant. The left Fitlight will change colors in the order of red, yellow, then green. Once the trial has started, the lights will flash different "no-go" colors once per second until the determined wait time has elapsed. One randomly selected light will change to the "go" color while the other lights will be a highly contrasted "no-go" color. All three added wait times are tested for each leg.

Trial Locations

Locations (1)

University of North Carolina at Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States