RecruitingNot Applicable

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

United Kingdom55 participantsStarted 2024-01-17

Plain-language 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.

Who can participate

Age range

18 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: 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. * No contraindications to strength testing (see exclusion criteria). 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. Exclusion Criteria: * 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Force generated

Timeframe: 30 minutes

Trial details

NCT IDNCT06235736

SponsorUniversity of Liverpool

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-12-31

Contact for this trial

Richard Norris

07766718618 Richard.Norris2@liverpoolft.nhs.uk

View on ClinicalTrials.gov More ACL Tear trials