Adding Neurocognitive Component to Balance Test

NCT06827483 | Enrolling By Invitation

• 1 other identifier: Pro00117009
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Anterior Cruciate Ligament Injuries

Keywords

ACL; Y-Balance Test; Reaction Time; Return to Sport

Outcome Measures

Primary Outcomes (3)

• Y-Balance Test - reach distance with and without neurocognitive component

  Reach Distances and Composite Score compared between left and right sides.

  Day 1

• Y-Balance Test - composite score with and without neurocognitive component

  Composite Score compared between left and right sides.

  Day 1

• Reaction Time Asymmetry between limbs

  Difference in reaction time between limbs

  Day 1

Secondary Outcomes (4)

• Reliability of Y-Balance Test - Inter-rater

  Day 8

• Reliability of Y-Balance Test - Intra-rater

  Day 8

• Reliability of Reaction Time Measurements - Inter-rater

  Day 8

• Reliability of Reaction Time Measurements - Intra-rater

  Day 8

Study Arms (2)

Healthy individuals

Healthy individuals without a history of ACL injury or reconstruction

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

Other: Neurocognitive Component

Interventions

Neurocognitive Component OTHER

A neurocognitive component will be added to the Y Balance Test

ACL (anterior cruciate ligament) reconstruction patients; Healthy individuals

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke Sports Science Institute

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Study Officials

• Robert Tisherman, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2025
• First Posted: February 14, 2025
• Study Start: March 14, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)