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

April 30, 2026 updated by: University of Liverpool

Do Patients With Anterior Cruciate Ligament (ACL) Tears Demonstrate Weakness of the Soleus Muscle?

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.

Study Overview

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

55

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Force generated
Time Frame: 30 minutes
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
IKDC score
Time Frame: 5 minutes
Participants will be required or complete an IKDC score to assess their knee stability
5 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Rachel Oldershaw, University of Liverpool

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 17, 2024

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

January 23, 2024

First Submitted That Met QC Criteria

January 23, 2024

First Posted (Actual)

February 1, 2024

Study Record Updates

Last Update Posted (Actual)

May 6, 2026

Last Update Submitted That Met QC Criteria

April 30, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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