Anterior Cruciate Ligament InjuriesNEURO-ACLNCT07163468
Neuromusculoskeletal Alterations After ACL Injury
An observational study of Anterior Cruciate Ligament Injuries and Sports Injury, run by Duzce University at 1 site in Turkey (Türkiye).
Trial summary
This study investigated how anterior cruciate ligament (ACL) injuries affect not only the knee joint but also brain activity, reaction speed, and psychological readiness to return to sports. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Anterior Cruciate Ligament Injuries, Sports Injury, Neurocognitive Function
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2025to 1 Aug 2025
- Phase
- Observational
- 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 30 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: The study population consisted of 60 male athletes aged 18 to 30 years. Participants were divided into three groups: healthy controls with no history of knee injury, athletes with primary ACL reconstruction, and athletes with revision ACL reconstruction. All were actively engaged in regular sports participation and had completed ACL rehabilitation at least 6 months prior to enrollment.
Who may be able to join
- Male athletes
- Age between 18 and 30 years
- Regular participation in amateur or professional sports
- Completion of ACL rehabilitation (for surgical groups) at least 6 months before enrollment
- Ability to undergo EEG and reaction time testing
- Provision of signed informed consent
Who cannot join
- History of neurological or psychiatric conditions (e.g., epilepsy, ADHD, depression)
- Additional lower extremity injuries or orthopedic surgeries
- Metal implants or scalp conditions incompatible with EEG
- Uncorrected visual or auditory deficits
- Systemic illnesses (e.g., diabetes, multiple sclerosis, neuropathy)
- Use of psychoactive medication
- Any cognitive or physical limitation interfering with testing procedures
- Female participants (to avoid hormonal confounding effects on EEG recordings)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neuromusculoskeletal Alterations After ACL Injury: A Cross-Sectional Study of Cortical Activity, Motor Response, and Psychological Readiness
This study investigated how anterior cruciate ligament (ACL) injuries affect not only the knee joint but also brain activity, reaction speed, and psychological readiness to return to sports. A total of 60 male athletes, aged 18 to 30 years, were evaluated in three groups: healthy athletes, athletes who had undergone primary ACL reconstruction, and athletes who had undergone revision ACL reconstruction.
The study measured brain activity with electroencephalography (EEG), reaction time with a computer-based test, and psychological status with standardized questionnaires. The findings showed that athletes with revision ACL surgery had more difficulties in attention control, slower reaction times, and greater psychological barriers compared to the other groups.
These results suggest that ACL injuries and surgeries may influence not only physical recovery but also brain function and psychological readiness. The study highlights the importance of considering neuromuscular, cognitive, and emotional aspects when planning rehabilitation and return-to-sport decisions.
- Keywords
- Anterior Cruciate Ligament, Kinesiophobia, Electroencephalography
- Medical subject headings
- Anterior Cruciate Ligament Injuries, Athletic Injuries, Kinesiophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Control Group | Athletes with no history of knee injury or surgery (n=20). | |
| Primary ACL Reconstruction Group | Athletes who had undergone a single ACL reconstruction, with rehabilitation completed at least 6 months prior to enrollment (n=20). | |
| Revision ACL Reconstruction Group | Athletes who had undergone at least two ACL surgeries including revision, with rehabilitation completed at least 6 months prior to enrollment (n=20). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frontal EEG Theta/Beta Ratio
Cortical activity measured at F3 and F4 electrode sites using EEG (Nexus-10 system, Mind Media, Netherlands). Theta (4-8 Hz) and beta (13-21 Hz) power spectral densities were calculated and the ratio (theta/beta) was used as an indicator of attentional control. Higher ratios indicate reduced attention and cognitive efficiency.
Measured: Single assessment on the study day (June-July 2025)
Secondary outcomes (3)
Visual Reaction Time (ms)
Computer-based visual response task; mean reaction time (ms) computed across 5 valid trials after practice. Longer times indicate lower sensorimotor efficiency.
Measured: Single assessment on the study day (June-July 2025)
Kinesiophobia (TSK-11 total score)
Tampa Scale of Kinesiophobia-11; 11 items, 1-4 Likert; total score 11-44. Higher scores indicate greater fear of movement/reinjury.
Measured: Single assessment on the study day (June-July 2025)
Psychological Readiness to Return to Sport (ACL-RSI total score)
ACL-RSI questionnaire; 12 items scored 0-100; total reported as mean (0-100). Higher scores indicate greater psychological readiness.
Measured: Single assessment on the study day (June-July 2025)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2025
- Study start1 Jun 2025
- Primary completion15 Jul 2025
- Study completion1 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anterior Cruciate Ligament InjuriesStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duzce University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Veysel Uludag, Duzce University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07163468
- Sponsor's protocol ID
- 2025/177
- Acronym
- NEURO-ACL
- Status last verified
- Sep 2025
- First submitted
- 1 Sep 2025
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared because the dataset is small, contains sensitive neurophysiological and psychological information, and was collected under conditions that limit external data access. Data may be available in aggregated form upon reasonable request to the corresponding author.
Publications
Kaya HB, Karaduman ZO, Akpinar S, Arican M, Saglam S, Aksit S, Koc M, Uludag V. Neuromusculoskeletal alterations after ACL reconstruction: a cross-sectional study of cortical activity, motor response, and psychological readiness. BMC Sports Sci Med Rehabil. 2025 Nov 29;18(1):65. doi: 10.1186/s13102-025-01450-6.
PubMed 41318585
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromusculoskeletal Alterations After ACL Injury: A Cross-Sectional Study of Cortical Activity, Motor Response, and Psychological Readiness
- ClinicalTrials.gov ID
- NCT07163468
- Acronym / sponsor ID
- NEURO-ACL / 2025/177
- Keywords
- Anterior Cruciate Ligament, Kinesiophobia, Electroencephalography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Duzce UniversityUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 15 Jul 2025 (actual)
- Study completion
- 1 Aug 2025 (actual)
- First posted
- 9 Sep 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 investigated how anterior cruciate ligament (ACL) injuries affect not only the knee joint but also brain activity, reaction speed, and psychological readiness to return to sports. A total of 60 male athletes, aged 18 to 30 years, were evaluated in three groups: healthy athletes, athletes who had undergone primary ACL reconstruction, and athletes who had undergone revision ACL reconstruction.
The study measured brain activity with electroencephalography (EEG), reaction time with a computer-based test, and psychological status with standardized questionnaires. The findings showed that athletes with revision ACL surgery had more difficulties in attention control, slower reaction times, and greater psychological barriers compared to the other groups.
These results suggest that ACL injuries and surgeries may influence not only physical recovery but also brain function and psychological readiness. The study highlights the importance of considering neuromuscular, cognitive, and emotional aspects when planning rehabilitation and return-to-sport decisions.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy Control Group | – | –Athletes with no history of knee injury or surgery (n=20). |
| Primary ACL Reconstruction Group | – | –Athletes who had undergone a single ACL reconstruction, with rehabilitation completed at least 6 months prior to enrollment (n=20). |
| Revision ACL Reconstruction Group | – | –Athletes who had undergone at least two ACL surgeries including revision, with rehabilitation completed at least 6 months prior to enrollment (n=20). |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study population consisted of 60 male athletes aged 18 to 30 years. Participants were divided into three groups: healthy controls with no history of knee injury, athletes with primary ACL reconstruction, and athletes with revision ACL reconstruction. All were actively engaged in regular sports participation and had completed ACL rehabilitation at least 6 months prior to enrollment.
Key inclusion criteria (6 listed)
- Male athletes
- Age between 18 and 30 years
- Regular participation in amateur or professional sports
- Completion of ACL rehabilitation (for surgical groups) at least 6 months before enrollment
- Ability to undergo EEG and reaction time testing
Key exclusion criteria (8 listed)
- History of neurological or psychiatric conditions (e.g., epilepsy, ADHD, depression)
- Additional lower extremity injuries or orthopedic surgeries
- Metal implants or scalp conditions incompatible with EEG
- Uncorrected visual or auditory deficits
- Systemic illnesses (e.g., diabetes, multiple sclerosis, neuropathy)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Frontal EEG Theta/Beta Ratio
Time frame: Single assessment on the study day (June-July 2025)
Cortical activity measured at F3 and F4 electrode sites using EEG (Nexus-10 system, Mind Media, Netherlands). Theta (4-8 Hz) and beta (13-21 Hz) power spectral densities were calculated and the ratio (theta/beta) was used as an indicator of attentional control. Higher ratios indicate reduced attention and cognitive efficiency.
3 secondary outcomes
Visual Reaction Time (ms)
Time frame: Single assessment on the study day (June-July 2025)
Kinesiophobia (TSK-11 total score)
Time frame: Single assessment on the study day (June-July 2025)
Psychological Readiness to Return to Sport (ACL-RSI total score)
Time frame: Single assessment on the study day (June-July 2025)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- Derived from this study: PubMed 41318585Kaya HB, Karaduman ZO, Akpinar S, Arican M, Saglam S, Aksit S, Koc M, Uludag V. Neuromusculoskeletal alterations after ACL reconstruction: a cross-sectional study of cortical activity, motor response, and psychological readiness. BMC Sports Sci Med Rehabil. 2025 Nov 29;18(1):65. doi: 10.1186/s13102-025-01450-6.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared because the dataset is small, contains sensitive neurophysiological and psychological information, and was collected under conditions that limit external data access. Data may be available in aggregated form upon reasonable request to the corresponding author.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anterior Cruciate Ligament Injuries and Sports Injury, run by Duzce University at 1 site in Turkey (Türkiye).
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 6 inclusion and 8 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: finished, as of the sponsor's last update on 15 Sep 2025. 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 Turkey (Türkiye). 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Frontal EEG Theta/Beta Ratio (time frame: Single assessment on the study day (June-July 2025)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07163468, which also lists 1 linked publication.
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 15 Sep 2025.