NCT06235736 Do Patients With ACL Tears Demonstrate Weakness of the Soleus Muscle?
| NCT ID | NCT06235736 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Liverpool |
| Condition | ACL Tear |
| Study Type | OBSERVATIONAL |
| Enrollment | 55 participants |
| Start Date | 2024-01-17 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 55 participants in total. It began in 2024-01-17 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Rachel Oldershaw
PRINCIPAL INVESTIGATOR
University of Liverpool
Frequently Asked Questions
Who can join the NCT06235736 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 55 Years, studying ACL Tear. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06235736 currently recruiting?
Yes, NCT06235736 is actively recruiting participants. Contact the research team at Richard.Norris2@liverpoolft.nhs.uk for enrollment information.
Where is the NCT06235736 trial being conducted?
This trial is being conducted at Liverpool, United Kingdom.
Who is sponsoring the NCT06235736 clinical trial?
NCT06235736 is sponsored by University of Liverpool. The principal investigator is Rachel Oldershaw at University of Liverpool. The trial plans to enroll 55 participants.