Efficacy of Surgery for Idiopathic Toe Walking
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Achilles Lengthening Surgery.
- Who it may be relevant to
- Registry conditions: Idiopathic Toe-walking. Basic parameters: 8 years — 16 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluating the Efficacy of Surgical Intervention for Idiopathic Toe Walking: A Prospective Cohort Pilot Study
Overview
BACKGROUND: For children who walk on their tip toes, surgery is often done to lengthen their Achilles Tendon. However, there is little research to help children's surgeons choose which children with idiopathic toe walking should have surgery. METHODS: This research study will investigate how effective surgery to lengthen the Achilles Tendon is for children with idiopathic toe walking. It will explore if the children\'s quality of life, endurance, strength, range of movement or walking pattern improves after they have had surgery. This study is a pilot study with 20 participants. This means the results will be used to decide if a larger trial is needed.
Detailed description
BACKGROUND:
It is common for children who learn to walk to walk on their tiptoes to help with their balance. However, approximately 7% of children will continue to walk on their toes past the age of three, with no diagnosis to explain why. This is called as idiopathic toe walking and can cause problems with balance, pain and playing sports.
For children with idiopathic toe walking who cannot touch their heels to the floor in standing, surgery is often done to lengthen their Achilles Tendon. This makes it easier to bend their foot towards their shin. They should then be able to walk. with their heels down in a more typical walking pattern.
However, this improvement is not always long-term. Some children experience problems after surgery, including weak legs. There is little research to help children's surgeons choose which children with idiopathic toe walking should have surgery.
METHODS:
This research study will investigate how effective surgery to lengthen the Achilles Tendon is for children with idiopathic toe walking. It will take part in two hospitals, Oxford University Hospitals and St George\'s Hospitals. It will explore if the children\'s quality of life, endurance, strength, range of movement or walking pattern improves after they have had surgery. This study is a pilot study. This means it is a smaller trial with 20 participants. The results will be used to decide if a larger trial is needed, and how a larger trial should be run.
The children in the study will be 8-16 years old, with a tight Achilles Tendon, who have been selected for surgery. They will receive usual care. This means their surgery will be no different than if they were not included in the study.
The children will be given questionnaires with a maximum of 22 questions before surgery, six months after surgery and one year after surgery. They will also do a single heel-rise test before surgery and one year after surgery. This will test if their calf muscle strength has changed after surgery. They will also complete a computerised walking analysis before surgery and one year after surgery. This will test if their walking pattern has changed after surgery. They will also complete a satisfaction questionnaire one year after surgery. This will ask about how satisfied they are with the surgery.
Interventions
- Procedure Achilles Lengthening Surgery
The procedure is undertaken under general anaesthetic and involves horizontal hemi-section of the Achilles tendon via small 'stab' incisions at three levels to effect a lengthening of the tendon. The patient is then placed in a walking cast for four weeks thereafter. This surgery is usual care for most children with symptomatic ITW with plantarflexion contractures who have failed non-operative management.
Primary outcome measures
- Oxford Ankle Foot Questionnaire for Children (OxAFQ-C) [Time frame: Pre-surgery / six months post-surgery / one year post-surgery]
Secondary outcome measures (6)
- EuroQol 5 Dimensions Youth (EQ-5D-Y) [Time frame: Pre-surgery / six months post-surgery / one year post-surgery]
- Single heel rise test [Time frame: Pre-surgery / one year post-surgery]
- Ankle range of motion [Time frame: Pre-surgery / one year post-surgery]
- Single question [Time frame: Pre-surgery / six months post-surgery / one year post-surgery]
- Patient Reported Experience Measure (PREM) [Time frame: One year post-surgery]
- Three Dimensional Gait Analysis (3DGA) [Time frame: Pre-surgery / one year post-surgery]
Eligibility criteria
Inclusion criteria
- Children aged 8-16 at recruitment.
- Idiopathic toe walkers based on clinicians' assessment.
- Plantarflexion contracture with knee extended of 0 degrees or less of dorsiflexion.
- Listed for surgical lengthening of the plantarflexors.
Exclusion criteria
- Unable to give informed assent or consent. Previous surgery to the lower limb.
- Unable to effectively participate in gait analysis (e.g. unable to walk 10-metres unaided, unable to walk independently, allergy to adhesive for skin markers, hyperhidrosis).
- Underlying diagnoses which may cause toe walking (e.g. muscular dystrophy, split cord malformation, cerebral palsy).
- Listed for additional procedures in the surgery for the lengthening of the plantarflexors.
- Awaiting further investigations or neurology assessment for toe walking pattern.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United Kingdom · 2 centers
- St George's University Hospitals NHS Foundation Trust — Tooting
- Oxford University Hospitals NHS Foundation Trust — Oxford
Identifiers
NCT: NCT06610591 · PID:17261