Adding Neurocognitive Component to Balance Test

NCT ID: NCT06827483

Last Updated: 2026-01-22

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-03-14
• Study Completion Date: 2026-12-31

Brief 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. 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.

Conditions

Anterior Cruciate Ligament Injuries

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Healthy individuals

Healthy individuals without a history of ACL injury or reconstruction

Neurocognitive Component

Intervention Type: OTHER

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

Neurocognitive Component

Intervention Type: OTHER

A neurocognitive component will be added to the Y Balance Test

Interventions

Neurocognitive Component

A neurocognitive component will be added to the Y Balance Test

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert Tisherman, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke Sports Science Institute

Durham, North Carolina, United States

Countries

United States

Other Identifiers

Pro00117009

Identifier Type: -

Identifier Source: org_study_id