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临床试验/NCT06827483
NCT06827483Enrolling By Invitation不适用

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

Duke University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年3月14日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
40
试验地点
1
主要终点
Y-Balance Test - reach distance with and without neurocognitive component

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 25 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

Healthy individuals

Healthy individuals without a history of ACL injury or reconstruction

干预措施: Neurocognitive Component (Other)

ACL (anterior cruciate ligament) reconstruction patients

Patients who have undergone ACL reconstruction and present for performance testing to measure readiness for sport participation

干预措施: Neurocognitive Component (Other)

结局指标

主要结局

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

时间窗: Day 1

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

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

时间窗: Day 1

Composite Score compared between left and right sides.

Reaction Time Asymmetry between limbs

时间窗: Day 1

Difference in reaction time between limbs

次要结局

  • 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)

研究者

发起方
Duke University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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