Efficacy of Surgery for Idiopathic Toe Walking
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Achilles Lengthening Surgery.
- Кому может быть актуально
- Состояния в реестре: Idiopathic Toe-walking. Базовые параметры: 8 лет — 16 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Великобритания
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Evaluating the Efficacy of Surgical Intervention for Idiopathic Toe Walking: A Prospective Cohort Pilot Study
Обзор
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.
Подробное описание
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.
Вмешательства
- Процедура 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.
Первичные конечные точки
- Oxford Ankle Foot Questionnaire for Children (OxAFQ-C) [Срок оценки: Pre-surgery / six months post-surgery / one year post-surgery]
Вторичные конечные точки (6)
- EuroQol 5 Dimensions Youth (EQ-5D-Y) [Срок оценки: Pre-surgery / six months post-surgery / one year post-surgery]
- Single heel rise test [Срок оценки: Pre-surgery / one year post-surgery]
- Ankle range of motion [Срок оценки: Pre-surgery / one year post-surgery]
- Single question [Срок оценки: Pre-surgery / six months post-surgery / one year post-surgery]
- Patient Reported Experience Measure (PREM) [Срок оценки: One year post-surgery]
- Three Dimensional Gait Analysis (3DGA) [Срок оценки: Pre-surgery / one year post-surgery]
Критерии участия
Критерии включения
- 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.
Критерии исключения
- 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.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Великобритания · 2 центра
- St George's University Hospitals NHS Foundation Trust — Tooting
- Oxford University Hospitals NHS Foundation Trust — Oxford
Идентификаторы
NCT: NCT06610591 · PID:17261