enGIneering For sporT for All
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- gait analysis with standard ankle foot orthosis
研究概览
简要总结
hemiplegia is a pathological condition that affects one side of the body which is associated with difficulty in maintaining an upright posture and walking and which is commonly compensated for by using orthoses (AFO). However, the orthoses are inadequate for sports from a design and prescription point of view, which specifies that the goal of the orthosis is to support walking and that any other use compromises its reliability.
The main objective therefore provides for an improvement in the involvement of these children in sports activities (both at school and during leisure time) through the development of new generation orthoses.
详细描述
The main objective therefore provides for an improvement in the involvement of these children in sports activities (both at school and during leisure time) through the development of new generation orthoses.
Secondary objective: the second objective involves the verification of the orthosis previously designed and built, ie the device must comply with the project specifications and allow the patient to perform sports activities. Correct functioning will be tested by functional evaluation of the model developed through biomechanical analysis of movement performed indoors (in the laboratory) and outdoors.
Notes on the calculation of the sample size: the project foresees the involvement at the moment of 20 children with hemiplegia under treatment at MEDEA to whom an overall improvement of the living conditions is to be guaranteed.
Steps: 1-Technology design - "to play together" 2 - Analysis and identification of the guidelines for the prescription of use; 3 - Evaluation of the motor biomechanical situation of subjects wearing orthoses: indoor and outdoor to evaluate the limits of the orthosis used; 4 - identification of indicators for the evaluation of motor performance; 5 - Identification of the technical specifications (functional and clinical, mechanical, structural, geometric, materials, design) of the new generation orthosis-sensor system.
6- Definition of inclusion criteria, recruitment of 20 subjects starting from Medea and contacts with schools and families to which they belong.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Users of Ankle Foot Orthosis (AFO) without any time limit;
- •GMFCS 1-2 scale values;
- •Ashworth triceps sural values <= 3.
排除标准
- •patients using knee and hip orthoses (KAFO, HKAFO);
- •patients who need assisted walking (use of crutches, walkers or other);
- •uncooperative patients.
结局指标
主要结局
gait analysis with standard ankle foot orthosis
时间窗: The evaluations are performed before the new ankle foot orthosis is delivered
kinematic (joint angle during gait cycle) and kinetic evaluation (power generation and absorption and moments) both with standard orthosis
gait analysis with experimental ankle foot orthosis
时间窗: The evaluations are performed 1 month after the new ankle foot orthosis is delivered
kinematic (joint angle during gait cycle) and kinetic evaluation (power generation and absorption and moments) both with experimental orthosis
次要结局
- G- sensor with standard ankle foot orthosis(The evaluations are performed before the new ankle foot orthosis is delivered)
- G- sensor with experimental ankle foot orthosis(The evaluation is performed 1 month after the new ankle foot orthosis is delivered)