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Exploring Prolonged AMR in ACL Reconstructed Patients

NCT06430775 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 190

Last updated 2024-07-01

No results posted yet for this study

Summary

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.

Conditions

  • Anterior Cruciate Ligament Injuries
  • Anterior Cruciate Ligament Rupture
  • Anterior Cruciate Ligament Tear
  • ACL
  • ACL Injury
  • ACL Tear
  • Anterior Cruciate Ligament Reconstruction
  • Arthrogenic Muscle Inhibition
  • Arthrogenic Muscle Responses

Sponsors & Collaborators

  • Research Foundation Flanders

    collaborator OTHER

  • University Ghent

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-15
Primary Completion
2026-05-31
Completion
2026-05-31

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06430775 on ClinicalTrials.gov