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Enrolling By InvitationNCT06827483

Adding Neurocognitive Component to Balance Test

Identifying Asymmetries in Reaction Time and Reach Distance by Adding a Neurocognitive Component to the Y-Balance Test of the Lower Quarter

Status
Enrolling By Invitation
Phase
Study type
Observational
Enrollment
40 (estimated)
Sponsor
Duke University · Academic / Other
Sex
All
Age
18 Years – 25 Years
Healthy volunteers
Accepted

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

Interventions

TypeNameDescription
OTHERNeurocognitive ComponentA neurocognitive component will be added to the Y Balance Test

Timeline

Start date
2025-03-14
Primary completion
2026-12-31
Completion
2026-12-31
First posted
2025-02-14
Last updated
2026-03-05

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT06827483. Inclusion in this directory is not an endorsement.