Anterior Cruciate Ligament (ACL) TearACLs SUCKNCT07058467
Anterior Cruciate Ligaments: Studying Updates in neuroCognition After Knee Manipulation
A study testing Joint Manipulation in people with Anterior Cruciate Ligament (ACL) Tear and Anterior Cruciate Ligament Reconstruction Rehabilitation, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Anterior Cruciate Ligament (ACL) Tear, Anterior Cruciate Ligament Reconstruction Rehabilitation
- What is being tested?
- Joint Manipulation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2025to 1 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
About this study
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:
Read more
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
- Being tested
- Joint Manipulation
- Keywords
- ACL, Anterior Cruciate Ligament, ACLR, Neurocognition
- Medical subject headings
- Lacerations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Joint ManipulationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Knee manipulation post ACLR | Experimental | This group, which comprises the entire cohort, will receive knee joint manipulations coinciding with grade III+ measures. Receives: Other: Joint Manipulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
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.
Measured: Baseline and up to 90 minutes after completion of joint manipulation (intervention)
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.
Measured: 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
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.
Measured: Baseline and up to 90 minutes after completion of joint manipulation (intervention)
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.
Measured: 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
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.
Measured: Baseline and up to 90 minutes after completion of joint manipulation (intervention)
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.
Measured: Baseline and up to 90 minutes after completion of joint manipulation (intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2025
- Study start1 Aug 2025
- Primary completion1 Apr 2026
- Study completion1 Apr 2026
Why it stopped: Funding not received.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament (ACL) TearStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single arm, pre-post cohort
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shelby Baez, PhD, ATC, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07058467
- Sponsor's protocol ID
- 25-0824
- Acronym
- ACLs SUCK
- Status last verified
- Apr 2026
- First submitted
- 18 Jun 2025
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anterior Cruciate Ligaments: Studying Updates in neuroCognition After Knee Manipulation
- ClinicalTrials.gov ID
- NCT07058467
- Acronym / sponsor ID
- ACLs SUCK / 25-0824
- Conditions
- Anterior Cruciate Ligament (ACL) Tear, Anterior Cruciate Ligament Reconstruction Rehabilitation
- Keywords
- ACL, Anterior Cruciate Ligament, ACLR, Neurocognition
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding not received.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 1 Apr 2026 (actual)
- Study completion
- 1 Apr 2026 (actual)
- First posted
- 10 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm, pre-post cohort
| Arm | Type | Receives |
|---|---|---|
| Knee manipulation post ACLR | Experimental | Other: Joint ManipulationThis group, which comprises the entire cohort, will receive knee joint manipulations coinciding with grade III+ measures. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Joint ManipulationA 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. | Other | Knee manipulation post ACLR |
Primary outcome
Change in Simple Reaction Time
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
6 secondary outcomes
Change in Mean Single Leg Hop Distance For Level 1 Neurocognitive Hop Test
Time frame: Baseline and up to 90 minutes after completion of joint manipulation (intervention)
Change in Mean Reaction Time For Level 1 Neurocognitive Hop Test
Time frame: 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
Time frame: Baseline and up to 90 minutes after completion of joint manipulation (intervention)
Change in Mean Reaction Time For Level 2 Neurocognitive Hop Test
Time frame: 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
Time frame: Baseline and up to 90 minutes after completion of joint manipulation (intervention)
Change in Mean Reaction Time For Level 3 Neurocognitive Hop Test
Time frame: Baseline and up to 90 minutes after completion of joint manipulation (intervention)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shelby Baez, PhD, ATC principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Joint Manipulation in people with Anterior Cruciate Ligament (ACL) Tear and Anterior Cruciate Ligament Reconstruction Rehabilitation, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Simple Reaction Time (time frame: Baseline and up to 90 minutes after completion of joint manipulation (intervention)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.