Evertor Muscle Activity as a Predictor of Achilles Tenotomy in the Management of Idiopathic Varus Equinus Clubfoot
This study aims to understand how muscle activity in a baby's leg might predict the need for a minor surgery called an Achilles tenotomy for clubfoot. Clubfoot is a common condition where a baby's foot is turned inwards. Doctors currently use a score called the Dimeglio score to assess clubfoot, but it doesn't focus much on muscles. This new study is using a special muscle scale to see if there's a link between how active the muscles are and whether a baby will need the small Achilles tenotomy procedure. They also want to make sure this new muscle scale gives similar results when used by different health professionals. The study will follow about 100 babies with clubfoot for up to a year, helping doctors understand the condition better and potentially tailor treatments earlier.
At a glance
What is this study about?
This research is looking into a common condition called clubfoot, which affects babies' feet from birth. When a baby has clubfoot, their foot is turned inwards. Doctors often use a way of scoring the clubfoot called the Dimeglio score, but this score doesn't spend much time looking at how well the muscles are working. We know that in clubfoot, there's often an imbalance in the strength of the muscles in the leg and foot.
This study wants to introduce a new way to measure muscle activity in babies with clubfoot, based on the existing Dimeglio score. The main goal is to find out if the level of muscle activity can predict whether a baby will need a small operation called an Achilles tenotomy before their first birthday. An Achilles tenotomy is a common and quick procedure that helps to loosen a tight tendon in the heel. By understanding this better, doctors hope to be able to predict which babies might need this procedure earlier, and potentially adjust their treatment plans.
Another important part of the study is to check if this new muscle activity scale gives consistent results when different doctors or health professionals use it. This is important to make sure the scale is reliable and can be used effectively in the future. Over eight years, the study will follow around 100 babies with clubfoot, checking their muscle activity at different times during their first year of life.
Key takeaways
- Aims to predict if babies with clubfoot will need a small surgery (Achilles tenotomy).
- Uses a new muscle activity scale to assess clubfoot.
- Compares muscle activity with the need for surgery before 1 year of age.
- Also checks if different doctors get similar results with the new scale.
- Could help doctors tailor clubfoot treatment earlier in the future.
- Involves regular gentle assessments of the baby's foot over their first year.
Who may be eligible?
To be part of this study, babies must have a type of clubfoot called 'idiopathic clubfoot'. This means their clubfoot doesn't have an obvious cause, like another underlying health problem. They must also have started their clubfoot treatment using a method called the 'functional method' within 15 days of being born. This specific treatment method involves gentle stretching and casting to gradually correct the foot.
Babies would not be able to join the study if their clubfoot is caused by another health condition, often called 'syndromic clubfoot'. Also, if they started their clubfoot treatment using a different method or if they started their treatment more than 15 days after birth, they wouldn't be eligible for this particular study. The study is open to both boys and girls between birth and 12 months old.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Is my baby's clubfoot 'idiopathic' (no other known cause)?
- Was my baby's clubfoot treatment started using the 'functional method'?
- Did my baby start treatment within 15 days of birth?
- Is my baby between 0 and 12 months old?
- Is my baby receiving care at the study hospital or clinic?
What does participation involve?
If your baby takes part in this study, they will have their muscle activity assessed at the very first visit, before they are 15 days old. This assessment will involve a doctor gently stimulating your baby's foot muscles to check their activity, and will also include the standard Dimeglio score. These same simple assessments will then be repeated when your baby is around 3 months, 6 months, and 12 months old. The study will follow around 100 babies over an eight-year period, but each individual baby will be followed for up to one year from their birth.
Potential risks and benefits
Locations (1)
- Hopitaux Pediatriques de Nice Chu-LenvalVerified postcodeNice, France· Recruiting
Common questions
What is an Achilles tenotomy?
It's a very common, small operation where a doctor makes a tiny cut in the Achilles tendon at the back of the heel. This helps to lengthen the tendon and allow the foot to move more freely.
What is 'idiopathic clubfoot'?
This means the clubfoot happened without a known cause. It's the most common type and is not linked to other health problems.
How long will my baby be in the study?
Your baby will be followed for up to one year from the start of the study, with assessments at the beginning, and then at 3, 6, and 12 months.
Will my baby's treatment change if they join the study?
No, your baby will receive their usual high-quality clubfoot treatment. This study is about observing and learning from that treatment, not changing it.
What is the 'functional method' of treatment?
This is a common approach for clubfoot treatment that involves special exercises, stretches, and sometimes casts or braces to gently correct the foot's position over time.
How to find out more
Grégoire Peuchevrier
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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