跳至主要内容
临床试验/NCT06050005
NCT06050005招募中不适用

Knee Functionality Recovery Indicators in Athletes Submitted to Ligamentoplasty of the Anterior Cruciate Ligament

Universidade da Coruña2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2023年6月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
90
试验地点
2
主要终点
The International Knee Documentation Committee (IKDC) score

研究概览

简要总结

Anterior cruciate ligament (ACL) injuries are recurrent, especially in sports. There is still no consensus on the characterization of functional indicators in this clinical condition, as well as their correlation with measuring instruments and clinical functional tests. It is intended to study the changes in functionality of users undergoing this surgery, aiming with functional assessment scales at different times of recovery. This will allow deciding on more adapted recovery strategies, which can meet the musculoskeletal requirements of the user.

详细描述

It is proposed to carry by carrying out quasi-experimental, quantitative and analytical studies. The sample will consist of athletes who have started recovering from ACL surgery and who meet the previously established inclusion and exclusion criteria.

The study will use and compare functional tests (Star Excursion Balance Test, Lateral Step Down Test and Weight-Bearing Lunge Test) with measurement instruments: Knee and Osteoarthritis Outcome Score (KOOS), Lyshom Knee Scoring Scale, Lower Extremity Functional Score (LEFS), Return to Sport After Injury Scale (ACL-RSI) and IKDC Subjective Knee Evaluation Form.

The intervention will be performed on individual athletes who have had anterior cruciate ligament injury for the first time or recurrence of this ligament in the same knee or injury in the contralateral knee.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Start of physiotherapy in the preoperative context and continuation of recovery up to 2 weeks after surgery; age equal to or greater than 18 years; With or without meniscal injury; Be able to correctly fill in the assessment instruments and complete the Informed Consent Form;

排除标准

  • Concomitant bilateral injury/history of surgery or contralateral dysfunction; meniscal suture; cartilaginous injury; injury to the internal lateral ligament, external lateral ligament and posterior cruciate ligament; concomitant intra and extra-articular plastic surgery; individuals with recent heart disease, intermittent claudication, neuropathies and cognitive alterations.

结局指标

主要结局

The International Knee Documentation Committee (IKDC) score

时间窗: At 24 weeks after ACL reconstruction surgery.

The International Knee Documentation Committee (IKDC) score was used to evaluate the knee health.The patients completed score by themselves. The lowest score is 0 and the highest score is 100.

Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI)

时间窗: At 24 weeks after ACL reconstruction surgery.

It is a specific 12-item questionnaire assessing the psychological impact (emotions, confidence in performance and evaluation of risk) of returning to sport after ACL reconstruction. Scores range from 0 to 100, and high scores were related to a positive psychological response

Lysholm Rating Scale

时间窗: At 24 weeks after ACL reconstruction surgery.

This scale consists of eight items. It is scored on a scale of 0 to 100 with higher scores indicating fewer symptoms and higher levels of functioning.

Dynamic knee stability

时间窗: At 24 weeks after ACL reconstruction surgery.

Single hop test. In this test, the aim is to jump as far as possible on a single leg, without losing balance and landing firmly. The distance is measured from the start line to the heel of the landing leg. The goal is to have a less than 10% difference in hop distance between the injured limb and uninjured limb.

Knee Injury and Osteoarthritis Outcome Score (KOOS)

时间窗: At 24 weeks after ACL reconstruction surgery.

The dimensions from this scale are divided into 5 items (Symptoms, Pain, Activities of Daily Living, Sports and Leisure Activities and Quality of Life) on a positive orientation scale from 0 (extreme knee problems) to 100 (no knee problems).

Dynamic balance

时间窗: At 24 weeks after ACL reconstruction surgery.

Change from baseline in a functional test - Y Balance Test

Lower Extremity Functional Scale (LEFS)

时间窗: At 24 weeks after ACL reconstruction surgery.

This measurement instrument consists of 20 items, each of which is scored on a scale five points, from zero to four. The total LEFS score, with a minimum value of zero - low functional level - and maximum of 80 - high functional level, which can be exposed in percentage terms.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sérgio Miguel Loureiro Nuno

MSc in Physical Therapy and Movement Analysis and PhD student in Health Sciences

Universidade da Coruña

研究点 (2)

Loading locations...

相似试验