Do Patients With ACL Tears Demonstrate Weakness of the Soleus Muscle?
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-55
SponsorUniversity of Liverpool
About this trial
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
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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.
Trial 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.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
55 Participants
are grouped into 2 trial groupsGroup A: MRI-confirmed ACL tear group
Group B: Normative group
Trial outcomes
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.
Time frame
30 minutesSecondary outcomes
1
IKDC score
Participants will be required or complete an IKDC score to assess their knee stability
Time frame
5 minutesSponsors and contacts
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Source ClinicalTrials.gov