Investigation of the Effect of Elastic Lower Extremity Orthosis on Gait and Balance Parameters in Children With Spastic Cerebral Palsy: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Gait parameters assessed by Edinburgh Visual Gait Analysis
研究概览
简要总结
This randomized controlled trial aims to evaluate the effect of an elastic lower extremity orthosis on gait and balance in children with spastic cerebral palsy who present with an in-toeing gait pattern. The study compares conventional neurodevelopmental therapy alone to therapy combined with the orthosis.
详细描述
Cerebral palsy (CP) is a group of permanent disorders affecting movement and posture and is one of the most common causes of motor disability in children. One of the most frequent rotational gait abnormalities in children with spastic CP is in-toeing, which may result from increased femoral anteversion, internal tibial torsion, or foot deformities such as metatarsus varus or metatarsus adductus.
Elastic orthoses wrapped around the femoral region can generate active rotational forces and help modify the foot progression angle during gait. In early childhood, elastic external rotation straps starting from the foot can also be used for tibial rotation problems.
This randomized controlled trial will compare the effects of conventional neurodevelopmental therapy alone with therapy combined with the use of an elastic lower extremity orthosis.
Primary outcome measure: Gait parameters
Secondary outcome measure: Balance parameters
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Months 至 84 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntary participation
- •Diagnosis of spastic cerebral palsy
- •Gross Motor Function Classification System (GMFCS) level 1, 2, or 3
- •Age between 18 and 84 months
- •Presence of in-toeing gait pattern
排除标准
- •GMFCS level 4 or 5
- •Botulinum toxin injection or surgical intervention targeting the lower extremities or pelvis within the last 6 months
研究组 & 干预措施
Control Group: Neurodevelopmental Therapy
Participants receive conventional neurodevelopmental therapy only.
干预措施: Neurodevelopmental Therapy (Behavioral)
Intervention Group: Therapy + Elastic Orthosis
Participants receive conventional neurodevelopmental therapy plus elastic lower extremity orthosis.
干预措施: Elastic Lower Extremity Orthosis (Device)
Intervention Group: Therapy + Elastic Orthosis
Participants receive conventional neurodevelopmental therapy plus elastic lower extremity orthosis.
干预措施: Neurodevelopmental Therapy (Behavioral)
结局指标
主要结局
Gait parameters assessed by Edinburgh Visual Gait Analysis
时间窗: Baseline and 8 weeks after intervention
The Edinburgh Visual Gait Analysis Scale will be used to assess changes in gait patterns before and after the intervention. This scale consists of 17 items. Each item is scored between 0 and 2. A total score closer to zero indicates improved gait. The Edinburgh Visual Gait Analysis Scale was developed to quantitatively analyze gait parameters at different stages in recorded videos. During the assessment, children will be videotaped walking on a flat surface with their lower extremities bare. These recordings will assess each lower extremity during the stance and swing phases of gait.
次要结局
- Balance parameters assessed by Pediatric Balance Scale(Baseline and 8 weeks after intervention)
研究者
Halime ERKAN
Principal Investigator
Gazi University