Adding Neurocognitive Component to Balance Test

May 6, 2026 updated by: Duke University

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Duke Sports Science Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Healthy participants will be recruited from the community. Patient participants will be recruited from the study center's population of patients.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Healthy individuals
Healthy individuals without a history of ACL injury or reconstruction
Other: Neurocognitive Component
A neurocognitive component will be added to the Y Balance Test
ACL (anterior cruciate ligament) reconstruction patients
Patients who have undergone ACL reconstruction and present for performance testing to measure readiness for sport participation
Other: Neurocognitive Component
A neurocognitive component will be added to the Y Balance Test

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 1
Y-Balance Test - composite score with and without neurocognitive component
Time Frame: Day 1
Composite Score compared between left and right sides.
Day 1
Reaction Time Asymmetry between limbs
Time Frame: Day 1
Difference in reaction time between limbs
Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reliability of Y-Balance Test - Inter-rater
Time Frame: Day 8
Reliability of Y-Balance Test - Inter-rater
Day 8
Reliability of Y-Balance Test - Intra-rater
Time Frame: Day 8
Reliability of Y-Balance Test - Intra-rater
Day 8
Reliability of Reaction Time Measurements - Inter-rater
Time Frame: Day 8
Reliability of Reaction Time Measurements - Inter-rater
Day 8
Reliability of Reaction Time Measurements - Intra-rater
Time Frame: Day 8
Reliability of Reaction Time Measurements - Intra-rater
Day 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Investigators

  • Principal Investigator: Robert Tisherman, MD, Duke University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 14, 2025

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

July 1, 2027

Study Registration Dates

First Submitted

February 3, 2025

First Submitted That Met QC Criteria

February 10, 2025

First Posted (Actual)

February 14, 2025

Study Record Updates

Last Update Posted (Actual)

May 7, 2026

Last Update Submitted That Met QC Criteria

May 6, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00117009

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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