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Clinical Trials/NCT06430775
NCT06430775
Recruiting
Not Applicable

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

University Ghent1 site in 1 country190 target enrollmentOctober 15, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anterior Cruciate Ligament Injuries
Sponsor
University Ghent
Enrollment
190
Locations
1
Primary Endpoint
Voluntary quadriceps activation
Status
Recruiting
Last Updated
last year

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
October 15, 2023
End Date
May 2026
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

Voluntary quadriceps activation

Time Frame: 5 months post ACL reconstruction

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

Quadriceps and hamstrings activity / cocontraction during jumping tasks

Time Frame: 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.

Secondary Outcomes

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

Study Sites (1)

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