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临床试验/NCT06430775
NCT06430775招募中不适用

Exploring Prolonged Arthrogenic Muscle Responses and Associated Factors After Anterior Cruciate Ligament Reconstruction

University Ghent1 个研究点 分布在 1 个国家目标入组 190 人开始时间: 2023年10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
190
试验地点
1
主要终点
Voluntary quadriceps activation

研究概览

简要总结

The goal of this observational study is to explore the significance of subject-reported outcomes and clinical parameters in relation to the occurence of prolonged presence of arthrogenic muscle responses (AMR) in anterior cruciate ligament (ACL) reconstructed patients. The main questions it aims to answer are:

  1. Is there a link between the long-term occurence of AMR in ACL reconstructed patients and the level of kinesiophobia experienced before or after their ACL surgery? We hypothesize that ACL patients with higher levels of kinesiophobia are more likely to exhibit prolonged AMR as an unconscious reaction to protect their affected knee joint.

  2. Is the long-term presence of AMR in ACL reconstructed patients linked to their subjective knee function and stability (at certain time points throughout their recovery)? Our hypothesis is that poorer subjective knee function and stability might be associated with the presence of prolonged arthrogenic muscle responses in ACL reconstructed patients.

  3. Is the prolonged presence of AMR in ACL reconstructed patients linked to their pain levels (at certain time points throughout their recovery)? Our hypothesis is that ACL patients with higher pre- and/or postsurgical pain levels may exhibit a higher degree of long-lasting AMR.

  4. Is the long-term presence of AMR in ACL reconstructed patients linked to clinical parameters such as swelling, isometric quadriceps and hamstrings strength and knee range of motion (at certain time points throughout their recovery)? Our hypothesis is that ACL patients with poorer outcomes in terms of these clinical parameters may be more likely to exhibit prolonged AMR.

Participants will:

  • Fill in the following questionnaires 1 week before surgery and at 1 and 3 months after surgery:

  • Demopgraphical information

  • Knee Injury and Osteoarthritis Outcome Score (KOOS)

  • Lysholm Score (only question 1)

  • Tegner Activity Scale (current activity level, pre-injury activity level and desired activity level after recovery)

  • Numeric Rating Score (NRS) for pain levels during the day & during the night

  • ACL-Return to Sport after Injury Scale (ACL-RSI)

  • Complete a testing protocol 5 months after their surgery, which includes bilateral electromyographical measurements of the hamstrings and quadriceps during jumping tasks and a quadriceps inhibition measurement using the interpolated twitch method to evaluate the presence of prolonged AMR.

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 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 18-40 years old.
  • Having suffered an ACL rupture.
  • Undergoing a surgical ACL reconstruction in the AZ Delta hospital in Roeselare (Campus Brugsesteenweg).

排除标准

  • Revision ACL reconstruction.
  • Other severe injuries to the lower limbs within the past year.
  • Muscular or neurological disorders affecting lower limb functioning.
  • Fibromyalgia or chronic fatigue syndrome.

结局指标

主要结局

Voluntary quadriceps activation

时间窗: 5 months post ACL reconstruction

A torque-based isometric biodex measurement using the interpolated twitch technique.

Quadriceps and hamstrings activity / cocontraction during jumping tasks

时间窗: 5 months post ACL reconstruction

Electromyographical measurement of quadriceps and hamstrings activation during jumping tasks: bilateral countermovement jump, unilateral countermovement jump and unilateral vertical drop jump with a 90° medial turn. The cocontraction will be quantified with cocontraction indices.

次要结局

  • Patient reported knee function(5 months post ACL reconstruction)
  • Quadriceps strength(5 months post ACL reconstruction)
  • Hamstrings strength(5 months post ACL reconstruction)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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