Anterior Cruciate Ligament InjuriesNCT06827483
Adding Neurocognitive Component to Balance Test
An observational study of Anterior Cruciate Ligament Injuries, run by Duke University at 1 site in United States.
Trial summary
By introducing BlazePods as a neurocognitive addition to the YBT, this study aims to determine whether this addition impacts balance performance and/or reach distances between the operative and non-operative limbs of patients recovering from ACL reconstruction. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Anterior Cruciate Ligament Injuries
- What is being tested?
- Neurocognitive Component
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Mar 2025to 1 Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy participants will be recruited from the community. Patient participants will be recruited from the study center's population of patients.
Who may be able to join
- All participants: 18-25 years old
- All participants: MARX activity questionnaire of greater than 10
- All participants: able to follow verbal instructions
- For patient participants: ACL Repair or Reconstruction within past 5-7 months
Who cannot join
- Healthy participants: Chronic Ankle Instability
- Healthy participants: Prior lower extremity surgery
- Healthy participants: LE injury <6 months ago
- Healthy participants: current LE pain
- Healthy participants: visual deficits
- Healthy participants: vestibular or neurological deficits affecting balance
Show all 16Show fewer
- Healthy participants: unable to maintain single leg stance for 10 seconds
- Healthy participants: unable to read or speak English
- For patient participants: Chronic Ankle Instability
- For patient participants: current LE pain
- For patient participants: multi-ligament procedure
- For patient participants: prior surgery on uninvolved limb
- For patient participants: visual deficits
- For patient participants: vestibular or neurological deficits affecting balance
- For patient participants: unable to read or speak English
- For patient participants: unable to maintain single leg stance for 10 seconds
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Duke Sports Science Institute
Durham, North Carolina, 27705
About this study
Official title: Identifying Asymmetries in Reaction Time and Reach Distance by Adding a Neurocognitive Component to the Y-Balance Test of the Lower Quarter
By introducing BlazePods as a neurocognitive addition to the YBT, this study aims to determine whether this addition impacts balance performance and/or reach distances between the operative and non-operative limbs of patients recovering from ACL reconstruction. Findings will contribute to optimizing return-to-sport protocols and enhancing late-stage rehabilitation program designs.
Read the detailed description
The study team will measure performance under two conditions: the standard Y-Balance Test (YBT) and the YBT with an added neurocognitive component (YBT+NC). For the YBT+NC, the study team will attach Blaze Pods to the target area of the three reach indictors: anterior (A), posteromedial (PM), and posterolateral (PL). The Blaze Pods will light up in random sequences, requiring participants to slide the illuminated reach indicator as far as possible while maintaining balance on the stationary stance limb. Reaction time, individual reach distances (PM,PL,A), YBT composite score, and number of errors will be recorded and compared bilaterally.
To first establish feasibility and clinical utility, a pilot group of healthy participants will perform both the YBT and the YBT+NC with two simultaneous testers on two separate occasions separated by at least one day but no more than 28 days. The differences in reach distances, composite scores, and reaction times between the two test conditions will be compared. The study team will also determine intra- and inter-rater reliability as well as any learning effects.
For the patient cohort, the study team will employ a cross-sectional design to measure patients presenting for physical performance testing battery between 5-8 months post-anterior cruciate ligament reconstruction/repair (ACLR). This visit is standard of care for this population. If the patient is able to pass the initial screening test (maintain pain-free single leg balance for 10 seconds) a physical therapist will have the patient perform both the YBT and the YBT+NC as described above. The study team will compare the side-to-side differences between reaction time, reach distance, and number of errors (loss of balance) made.
- Conditions
- Anterior Cruciate Ligament Injuries
- Being tested
- Neurocognitive Component
- Keywords
- ACL, Y-Balance Test, Reaction Time, Return to Sport
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurocognitive ComponentOther
A neurocognitive component will be added to the Y Balance Test
| Study group | Role | What they receive |
|---|---|---|
| Healthy individuals | Healthy individuals without a history of ACL injury or reconstruction Receives: Other: Neurocognitive Component | |
| ACL (anterior cruciate ligament) reconstruction patients | Patients who have undergone ACL reconstruction and present for performance testing to measure readiness for sport participation Receives: Other: Neurocognitive Component |
What is being measured
The primary outcome is the main question the study is designed to answer.
Y-Balance Test - reach distance with and without neurocognitive component
Reach Distances and Composite Score compared between left and right sides.
Measured: Day 1
Y-Balance Test - composite score with and without neurocognitive component
Composite Score compared between left and right sides.
Measured: Day 1
Reaction Time Asymmetry between limbs
Difference in reaction time between limbs
Measured: Day 1
Secondary outcomes (4)
Reliability of Y-Balance Test - Inter-rater
Reliability of Y-Balance Test - Inter-rater
Measured: Day 8
Reliability of Y-Balance Test - Intra-rater
Reliability of Y-Balance Test - Intra-rater
Measured: Day 8
Reliability of Reaction Time Measurements - Inter-rater
Reliability of Reaction Time Measurements - Inter-rater
Measured: Day 8
Reliability of Reaction Time Measurements - Intra-rater
Reliability of Reaction Time Measurements - Intra-rater
Measured: Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2025
- Study start14 Mar 2025
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament InjuriesStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert Tisherman, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06827483
- Sponsor's protocol ID
- Pro00117009
- Status last verified
- Mar 2026
- First submitted
- 3 Feb 2025
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying Asymmetries in Reaction Time and Reach Distance by Adding a Neurocognitive Component to the Y-Balance Test of the Lower Quarter
- ClinicalTrials.gov ID
- NCT06827483
- Acronym / sponsor ID
- Pro00117009
- Conditions
- Anterior Cruciate Ligament Injuries
- Keywords
- ACL, Y-Balance Test, Reaction Time, Return to Sport
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 14 Mar 2025 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 14 Feb 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.
By introducing BlazePods as a neurocognitive addition to the YBT, this study aims to determine whether this addition impacts balance performance and/or reach distances between the operative and non-operative limbs of patients recovering from ACL reconstruction. Findings will contribute to optimizing return-to-sport protocols and enhancing late-stage rehabilitation program designs.
Detailed description
The study team will measure performance under two conditions: the standard Y-Balance Test (YBT) and the YBT with an added neurocognitive component (YBT+NC). For the YBT+NC, the study team will attach Blaze Pods to the target area of the three reach indictors: anterior (A), posteromedial (PM), and posterolateral (PL). The Blaze Pods will light up in random sequences, requiring participants to slide the illuminated reach indicator as far as possible while maintaining balance on the stationary stance limb. Reaction time, individual reach distances (PM,PL,A), YBT composite score, and number of errors will be recorded and compared bilaterally.
To first establish feasibility and clinical utility, a pilot group of healthy participants will perform both the YBT and the YBT+NC with two simultaneous testers on two separate occasions separated by at least one day but no more than 28 days. The differences in reach distances, composite scores, and reaction times between the two test conditions will be compared. The study team will also determine intra- and inter-rater reliability as well as any learning effects.
For the patient cohort, the study team will employ a cross-sectional design to measure patients presenting for physical performance testing battery between 5-8 months post-anterior cruciate ligament reconstruction/repair (ACLR). This visit is standard of care for this population. If the patient is able to pass the initial screening test (maintain pain-free single leg balance for 10 seconds) a physical therapist will have the patient perform both the YBT and the YBT+NC as described above. The study team will compare the side-to-side differences between reaction time, reach distance, and number of errors (loss of balance) made.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy individuals | – | Other: Neurocognitive ComponentHealthy individuals without a history of ACL injury or reconstruction |
| ACL (anterior cruciate ligament) reconstruction patients | – | Other: Neurocognitive ComponentPatients who have undergone ACL reconstruction and present for performance testing to measure readiness for sport participation |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy participants will be recruited from the community. Patient participants will be recruited from the study center's population of patients.
Key inclusion criteria (4 listed)
- All participants: 18-25 years old
- All participants: MARX activity questionnaire of greater than 10
- All participants: able to follow verbal instructions
- For patient participants: ACL Repair or Reconstruction within past 5-7 months
Key exclusion criteria (16 listed)
- Healthy participants: Chronic Ankle Instability
- Healthy participants: Prior lower extremity surgery
- Healthy participants: LE injury <6 months ago
- Healthy participants: current LE pain
- Healthy participants: visual deficits
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 |
|---|---|---|
| Neurocognitive ComponentA neurocognitive component will be added to the Y Balance Test | Other | ACL (anterior cruciate ligament) reconstruction patients, Healthy individuals |
Primary outcome
Y-Balance Test - reach distance with and without neurocognitive component
Time frame: Day 1
Reach Distances and Composite Score compared between left and right sides.
Y-Balance Test - composite score with and without neurocognitive component
Time frame: Day 1
Composite Score compared between left and right sides.
Reaction Time Asymmetry between limbs
Time frame: Day 1
Difference in reaction time between limbs
4 secondary outcomes
Reliability of Y-Balance Test - Inter-rater
Time frame: Day 8
Reliability of Y-Balance Test - Intra-rater
Time frame: Day 8
Reliability of Reaction Time Measurements - Inter-rater
Time frame: Day 8
Reliability of Reaction Time Measurements - Intra-rater
Time frame: Day 8
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Individual participant dataSharing planned: No
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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.
Robert Tisherman, MD principal investigator
Duke University
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, run by Duke University 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 4 inclusion and 16 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: enrolling by invitation, as of the sponsor's last update on 7 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?
This study is still under way. Results are not available in the source record yet.
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?
Y-Balance Test - reach distance with and without neurocognitive component (time frame: Day 1). The study lists 3 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 7 May 2026.