Do Patients With ACL Tears Demonstrate Weakness of the Soleus Muscle?

NCT06235736 | Recruiting

• 1 other identifier: UoL001827
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this prospective, cross-sectional study is to test the strength of the soleus muscle in participants who have a ACL tear confirmed by MRI. Previous studies have shown that the soleus muscle, which one of the muscles situated in the calf, decreases mechanical loading on the ACL. Therefore, we aim to test soleus muscle strength using a seated plantar flexor test. The main questions we aim to answer are:

• Do patients with ACL tears demonstrate inter-limb soleus strength asymmetry (\>10%)
• Do patients with ACL tears have soleus muscle weakness compared with uninjured (normative) participants?
• Do changes in soleus strength values correlate with patient reported outcomes and stability, as measured by the IKDC questionnaire? To achieve this the VALD force frame will be used as the testing device for plantar flexor strength testing. This device records the force generated by the movement. This will be repeated three times on each leg as part of the testing procedure. Furthermore, as part of the testing procedure participants will be required to fill out an IKDC form to assess their knee stability. Interrater reliability of the force frame will be investigated. Further data from participants without ACL tears will be used to compare results. Thus allowing us to see if people with ACL tears have a weakness in the soleus muscle.

Conditions

ACL Tear; ACL-injury; ACL - Anterior Cruciate Ligament Rupture

Keywords

Acute cruciate ligament; ACL; soleus muscle; physiotherapy; orthopaedics; trauma; rehabilitation

Outcome Measures

Primary Outcomes (1)

• Force generated

  The primary outcome will be to measure the force generated by the soleus muscle in both limbs. This data will be normalised to their body weight to compare.

  30 minutes

Secondary Outcomes (1)

• IKDC score

  5 minutes

Study Arms (2)

MRI-confirmed ACL tear group

This group will have had a complete ACL tear confirmed by MRI scan

Normative group

This group will provide normative data for the study. They will have no previous history of significant knee injury and no current symptomatic lower limb injuries.

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

A convenience sample of MRI-confirmed ACL injured patients, who are undergoing non-operative rehabilitation, will be recruited from Liverpool University Hospitals NHS Trust.. To account for potential bilateral weakness in muscle strength, normative values from a control group of healthy participants will be included. Healthy volunteers will be recruited from NHS staff at Liverpool University Hospitals NHS Foundation Trust. Volunteers will be approached directly via departmental email and face to face conversation or accepted via word of mouth. The international knee documentation committee (IKDC) questionnaire will be completed by the patient, to determine subjective knee stability.

You may qualify if:

• ACL tear participants:
• MRI-confirmed ACL tear.
• Participant is willing and able to give informed consent in writing for participation in the study.
• Male or Female, aged 18 years to 55 years of age.

You may not qualify if:

• Normative values from healthy individuals:
• No current or previous history of significant lower limb injury, or a history of previous minor injury that is symptomatic at the time of recruitment.
• No previous lower limb surgery.
• No course of medication, whether prescribed or over the counter, other than vitamins and mineral supplements or, for females, oral contraceptives.
• History of chronic musculoskeletal disease or disorder in either leg that may put the participants at risk because of participation in the study including non-united fractures, epilepsy, cardiac insufficiency, severe peripheral vascular disease, aneurysms, anticoagulant therapy, recent (\<3 months) radiotherapy or chemotherapy, long term steroid use (\>3 months), pregnancy, neurological disorders (e.g., Parkinson's disease), skin conditions at point of force testing, severe osteoporosis, malignancy, rheumatoid arthritis.
• Conditions or symptoms that may influence the result of the study, or the participant's ability to participate in the study including pain, limited range of motion, knee effusion, or anaemia.

Sponsors & Collaborators

• University of Liverpool: lead

Study Sites (1)

Aintree Hospital, Liverpool University Hospitals NHS Foundation Trust

Liverpool, L9 7AL, United Kingdom

RECRUITING

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries; Wounds and Injuries

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries

Study Officials

• Rachel Oldershaw

  University of Liverpool

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Richard Norris

CONTACT

07766718618; Richard.Norris2@liverpoolft.nhs.uk

Rachel Oldershaw

CONTACT

+441517932322; lrao1@liverpool.ac.uk

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2024
• First Posted: February 1, 2024
• Study Start: January 17, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 6, 2026

Record last verified: 2026-04

Locations

GB (1)