An observational study in ACL Tear, ACL-injury and ACL - Anterior Cruciate Ligament Rupture, sponsored by University of Liverpool. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-06.
Sponsored by University of Liverpool · Observational
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:
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.
To address the research question, we will collect and analyse measures of lower limb muscle strength, which together will inform on the strength/ weakness of the Soleus muscle in patients undergoing physiotherapy rehabilitation following MRI-confirmed ACL injury.
Patients identified as eligible according to the protocol inclusion and exclusion criteria will be invited to participate in the study through informed written consent so that their clinical measurements can be used as research data. Healthy volunteers will be identified by direct email invitation or word of mouth. Healthy volunteers will be members of staff at Aintree Hospital, LUHFT.
Patients will undergo the clinically established treatment pathway for rehabilitation with lower limb muscle strength and performance measurements taken from isometric seated calf raise using the Vald Forceframe and single leg jump using Vald Forcedecks. Measurements will be performed with maximal ankle dorsiflexion and the knee flexion angle greater than 90 degrees. Three submaximal warmups will be performed followed by three maximum efforts, taking the maximum reading for analysis.
Normative values from healthy participants will be collected using the same clinical protocol.
Patients and healthy participants will be asked to complete the international knee documentation committee (IKDC) questionnaire at the start and end of rehabilitation, to determine subjective complaints of instability.
625 studies on the registry are indexed under Anterior Cruciate Ligament Injuries; 192 are open to participants now.
This study's planned enrollment of 55 is below the median of 98 across 153 observational studies indexed under Anterior Cruciate Ligament Injuries.
Browse Anterior Cruciate Ligament Injuries studies →University of Liverpool is the lead sponsor of 99 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
ACL tear participants:
Normative values from healthy individuals:
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 use (>3 months), pregnancy, neurological disorders (e.g., Parkinson's disease), skin conditions at point of force testing, severe osteoporosis, , rheumatoid arthritis.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This group will have had a complete ACL tear confirmed by MRI scan
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.
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 minutes
IKDC score
Participants will be required or complete an IKDC score to assess their knee stability
Time frame: 5 minutes
Started Jan 2024 (actual). Primary completion is estimated for Dec 2027, 47 months after the start.
Of 73 non-industry observational studies under Anterior Cruciate Ligament Injuries, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 167. This study's planned 47 months is above that.
Counting every sponsor, half of 82 studies reached it within 37 months; a quarter within 13 and three quarters within 76.
How these figures are worked out, and which studies are left out of them.
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