跳至主要内容
临床试验/NCT05578248
NCT05578248招募中不适用

The Andrews Return to Sport ACL Score: A Developmental Study

Andrews Research & Education Foundation1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年2月3日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
100
试验地点
1
主要终点
International Knee Documentation Committee Subjective Knee Evaluation Form (IKDC)

研究概览

简要总结

This project will develop a data-driven decision making model to assess a competitive athlete's readiness to return to sport after ACL injury and surgery safely.

详细描述

One hundred pre-collegiate or collegiate athlete participants will be recruited for this study. The duration of the treatment plan will be 24 months. Each of the participants will be qualified for the study due to falling within all inclusion criterion and no exclusion criterion. The screening of the inclusion criterion will occur at visit one of the study. At this time, the AREF Research Team will review and collect informed consent from each participant. Visit two will occur three (3) months after each participant's ACL reconstruction surgery. At this time, an evaluation by the treating physician will occur along with functional movement assessment and MRI. Visit three will occur six (6) months after each participant's ACL reconstruction surgery. At this time, an evaluation by the treating physician will occur along with functional movement assessment and MRI. Visit four will occur nine (9) months after each participant's ACL reconstruction surgery. At this time, an medical evaluation by the treating leading physician will occur along with functional movement assessment and MRI. Visit five will occur twelve (12) months after each participant's ACL reconstruction surgery. At this time, an evaluation by the treating physician will occur along with functional movement assessment and MRI. Visit six will occur eighteen (18) months after each participant's ACL reconstruction surgery. At this time, an evaluation by the treating physician will occur along with functional movement assessment and MRI. Visit seven will occur twenty-four (24) months after each participant's ACL reconstruction surgery. At this time, an evaluation by the treating physician will occur along with functional movement assessment and MRI. At each time point, the treating physician or the therapist performing the functional movement assessment can choose to limit the functional movement assessment if there are concerns that the patient may not be ready for the expected load of one or more elements of the functional movement assessment.

At each monthly time point after ACL reconstruction, patient reported outcomes will be collected by the research team to assist in assessing the overall health and confidence in return to sport for each athlete. The following patient reported outcomes will be collected in written or electronic format after informed consent has been obtained from each participant: Sports Participation, Reinjury, Tampa Kinesiophobia Scale, IKDC, PROMIS, SANE.

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
14 Years 至 24 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Age 14-24 years
  • Require ACL reconstruction surgery
  • No other ligament injury which would require repair or reconstruction to lower extremity is present as assessed by treating physician
  • Exhibits desire to return to pre-injury competitive level
  • Assessed to be in good physical health condition by the treating physician

排除标准

  • Requires more than one ACL reconstruction surgery at time of screening
  • Has comorbid lower extremity diagnoses which would impede return to sport as assessed by the treating physician
  • Does not desire to return to pre-injury competitive sport level

结局指标

主要结局

International Knee Documentation Committee Subjective Knee Evaluation Form (IKDC)

时间窗: Every month, up to 1 year; assessing for change

19-question form that will contribute to comprehensive data set by evaluating confidence in perfomance

Patient Reported Outcomes Measurement Information Systems (PROMIS)

时间窗: Every month, up to 1 year; assessing for change

Assesses overall health functioning and rehabilitation levels of each participant; required to ensure that a comprehensive assessment of overall functioning is reviewed. Scores range from 20 to 80, with 50 representing the average for the general population, and increases in this number over 50 represent standard deviation, and thus represent slow recovery progress in this study

Tampa Scale for Kinesiophobia

时间窗: Through study completion, an average of 1 year

Measurement to determine the physical and pyschological effects on the rehabilitation of an injured athlete; 17-question survey with a total score calculated after inversion of the individual scores of items 4, 8, 12, and 16 (all questions are scored on a scale of 1-4 points).

Sports Participation Assessment

时间窗: Through study completion, an average of 1 year

Quantifies the participant's participation in sports activity during the rehabilitation period

Reinjury Assessment

时间窗: Through study completion, an average of 1 year

Monthly questionnaire to assess the rate of reinjury during rehabilitation process

Single Assessment Numeric Evaluation (SANE)

时间窗: Every month, up to 1 year; assessing for change

Single question PRO with a rating of 0-100 for each participant to score their current functioning in comparison to their pre-injury level of function

次要结局

未报告次要终点

研究者

发起方
Andrews Research & Education Foundation
申办方类型
Other
责任方
Sponsor

研究点 (1)

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