ClinicalTrials.gg
WithdrawnNCT07058467ACLs SUCKUpdated May 5, 2026

Anterior Cruciate Ligaments: Studying Updates in neuroCognition After Knee Manipulation

An interventional study of Joint Manipulation in Anterior Cruciate Ligament (ACL) Tear and Anterior Cruciate Ligament Reconstruction Rehabilitation, sponsored by University of North Carolina, Chapel Hill. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 35 Years. Per ClinicalTrials.gov, last updated 2026-05-05.

Sponsored by University of North Carolina, Chapel Hill · Not applicable, Interventional, and Treatment

Why this study was withdrawn
Funding not received.
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
18 Years to 35 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 60 studies in Lacerations with a site in United States — 12 open to participants now, 14 under way, 1 of them phase 3. Lacerations · United States.

Enrollment
48th of 52
0 · median 52
Started
2025
with 3 others
No phase
33 of 60
5 open now
Registered
53rd of 60
by date

Among the 60 studies in Lacerations with a site in United States, this one is the 48th largest by enrollment of the 52 interventional ones, is one of 4 that started in 2025, is one of 33 with no phase, and was the 53rd registered.

By phase

60 studies; the count open now beside each. This study's row is marked.

No phasethis study33 · 5 open
Phase 410 · 2 open
Observational7 · 2 open
Phase 26 · 1 open
Phase 11 · 1 open
Phase 1/21 · 0 open
Phase 2/31 · 0 open
Phase 31 · 1 open

By the year they started

First in 2000; this study’s year is marked. 4 started in 2025.

Size and results

Median enrollment 52 across the 52 interventional studies, 50 across the 7 observational. Of the 36 that completed or were terminated, 18 (50%) have results posted.

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02

Study 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.

03

Conditions studied

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

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Keywords

  • ACL
  • Anterior Cruciate Ligament
  • ACLR
  • Neurocognition
04

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Provided 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

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Knee manipulation post ACLR

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

    Other: Joint Manipulation

Interventions

  • OtherJoint 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.

06

What researchers measure

Primary outcomes

  1. 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.

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

  2. 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.

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

  3. 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.

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

  4. 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.

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

  5. 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.

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

Secondary outcomes

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

    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.

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

  2. Change in Mean Reaction Time For Level 1 Neurocognitive Hop Test

    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.

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

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

    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.

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

  4. Change in Mean Reaction Time For Level 2 Neurocognitive Hop Test

    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.

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

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

    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.

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

  6. Change in Mean Reaction Time For Level 3 Neurocognitive Hop Test

    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.

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

07

Study locations

1 site
  • University of North Carolina at Chapel Hill
    Chapel Hill, North Carolina 27599, United States
08

References and documents

Individual participant data

Plan to share: Yes — Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.

Supporting information: Study protocol, Statistical analysis plan

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.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Aug 2025 to primary completion in Apr 2026, 8 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 18, 2025
First posted
Jul 10, 2025
StartActual
Aug 1, 2025
Primary completionActual
Apr 1, 2026
CompletionActual
Apr 1, 2026
Last update
May 5, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07058467
Responsible party
Sponsor
First posted
Jul 10, 2025
Start date
Aug 1, 2025
Primary completion
Apr 1, 2026
Completion
Apr 1, 2026
Last update
May 5, 2026

Study contacts

Shelby Baez, PhD, ATC
principal investigator · University of North Carolina, Chapel Hill

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is withdrawn, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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