Effectiveness of Ankle-7 Orthosis vs HAFO Orthosis on Gait Performance in Diplegic Cerebral Palsied Children
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 10
- 主要终点
- Change from right and left ankle joints power generation in stance phase after the use of first orthosis to right and left ankle joints power generation in stance phase after the use of second orthosis
研究概览
简要总结
Ankle foot orthoses (AFO) are frequently used to improve locomotor skills of cerebral palsied children (CP) although the level of scientific evidence to support their use is still moderate. Carbon Ankle Seven spring (A7 - Otto Bock, Germany) is specifically designed to store energy when loaded and release it at toe-off in order to improve gait performance with respect to non-energy-storing AFOs. The aim of this work is to verify the superiority of the ankle-7 orthosis compared to the more widespread AFO, to improve the functionality and walking function of children with spastic diplegia and PCI.
详细描述
The project is divided into the following phases:
T0 - at the beginning of the study children included will be subject to the following procedures and assessments:
- demographic and anthropometric data collection;
- randomization by concealed allocation to one of the following two groups:
- AFO - Ankle_7 group
- Ankle-7 - AFO group Both, AFO and ankle-7, will be tailored to the patient
The two groups are distinguished by the order of the assignment of the two orthoses, respectively defined as the first assignment orthosis (O_1) and second assignment orthosis (O_2). The first group will use the orthoses AFO as a first assignment and then the orthoses Ankle_7, while the second group will use the two orthoses according to the reverse order. The two will be used with the same orthotic footwear, with the exception of the cases where it will be necessary to change it due to accretion. 3. collection of the measures necessary for making the two orthotic devices at OttoBock of Reggio Emilia 4. training in the use of the orthoses according to a standardized protocol; 5. try on the patient's in-process first assignment orthoses (O_1) and subsequent delivery of them (see Annex A);
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Clinical indication to the use of orthoses to improve the walking function confirmed by instrumental parameters obtained from analysis of the path (dynamic electromyography, optoelectronic stereophotogrammetry analysis);
- •Patients who already have AFO orthoses (or ankle-7) that need to be renewed;
- •Patients with new clinical indication to the use of orthoses but not yet in possession of the same;
- •Informed consent from parents / guardians of the child
排除标准
- •Cognitive disabilities that may affect the child's participation in the activities related to this study, in the opinion of the investigators;
- •Lower limbs sensory disability that may affect any beneficial effects of the use of the orthoses, in the opinion of the investigators;
- •Other diseases associated or not associated with PCI that, according to investigators, could affect the child's participation in the activities related to this study (eg: drug-resistant epilepsy);
- •Administration of antispasmodic drugs in the last 6 months;
- •Functional surgery of the lower limbs in the last 6 months;
- •Indication for surgical treatment to be carried out within 6 months after the date of inclusion in the study.
研究组 & 干预措施
AFO - Ankle_7 group
AFO is active comparator, ANKLE7 is the experimental treatment
干预措施: Carbon Ankle Seven spring (A7 - Otto Bock, Germany) (Device)
AFO - Ankle_7 group
AFO is active comparator, ANKLE7 is the experimental treatment
干预措施: Hinged AFO (Device)
Ankle-7 - AFO group
AFO is active comparator, ANKLE7 is the experimental treatment
干预措施: Hinged AFO (Device)
Ankle-7 - AFO group
AFO is active comparator, ANKLE7 is the experimental treatment
干预措施: Carbon Ankle Seven spring (A7 - Otto Bock, Germany) (Device)
结局指标
主要结局
Change from right and left ankle joints power generation in stance phase after the use of first orthosis to right and left ankle joints power generation in stance phase after the use of second orthosis
时间窗: After a 4-6 week period of use of first orthosis and after a 4-6 week period of use of second orthosis
Measured by instrumental gait analysis (ratio of watt to kilogram)
次要结局
- knee joint kinematics(After a 4-6 week period of use of first orthosis and after a 4-6 week period of use of second orthosis)
- stride length(After a 4-6 week period of use of first orthosis and after a 4-6 week period of use of second orthosis)
- walking speed(After a 4-6 week period of use of first orthosis and after a 4-6 week period of use of second orthosis)
- preference of use of AFO or Ankle_7(After a 4-6 week period of use of first orthosis, after a 4-6 week period of use of second orthosis and after 3 months after three months when the child could freely use both orthoses)
- clinical evaluation of the walking function(After a 4-6 week period of use of first orthosis and after a 4-6 week period of use of second orthosis)