Evaluating the Efficacy of Surgical Intervention for Idiopathic Toe Walking: A Prospective Cohort Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Oxford Ankle Foot Questionnaire for Children (OxAFQ-C)
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 8 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Oxford Ankle Foot Questionnaire for Children (OxAFQ-C)
时间窗: Pre-surgery / six months post-surgery / one year post-surgery
Quality of life tool
次要结局
- EuroQol 5 Dimensions Youth (EQ-5D-Y)(Pre-surgery / six months post-surgery / one year post-surgery)
- Single heel rise test(Pre-surgery / one year post-surgery)
- Ankle range of motion(Pre-surgery / one year post-surgery)
- Single question(Pre-surgery / six months post-surgery / one year post-surgery)
- Patient Reported Experience Measure (PREM)(One year post-surgery)
- Three Dimensional Gait Analysis (3DGA)(Pre-surgery / one year post-surgery)