The Effect of a Novel Gait Trainer, the Hibbot, on the Development of Crouch Gait in Children With Cerebral Palsy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Change in Lower limb kinematics during walking in degrees
研究概览
简要总结
The aim of the study is to assess the impact of the innovative walking aid HIBBOT on the functions, activity and participation of young children with Cerebral Palsy, in comparison with conventional walking aids.
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
- None
入排标准
- 年龄范围
- 18 Months 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At risk of or diagnosed with cerebral palsy, based on MRI (uCP 86 - 89 % sensitivity) or HINE (uCP 98% ) or standard motor assessment
- •age 18 months - 6 years
- •GMFCS level II - IV =with potential (=able to stand and walk when supported by a therapist at the level of the pelvis and lower trunk)
- •Sufficient cooperation to complete the tests.
排除标准
- •Hip dysplasia
- •Fixed contractures in the lower limb
- •Botox infiltration < 6 months prior to inclusion
- •Surgery < 12 months prior to inclusion
- •Insufficient understanding of the interventon and tests (based on mental level assessment)
- •Refractary epilepsia
结局指标
主要结局
Change in Lower limb kinematics during walking in degrees
时间窗: baseline (at intake, T0) and after the intervention period (3 months, T1)
The gait pattern is assessed by instrumented 3D gait analysis. Joint rotation angles of the major joints of the lower limbs will be described during walking.
Change in Muscle activation patterns during gait in microvolts
时间窗: baseline (at intake, T0) and after the intervention period (3 months, T1)
Surface electromyography signals will be recorded during gait
次要结局
- Lower limb kinematics during walking in degrees(at follow up (12 months after intake, T2))
- Muscle activation patterns during gait in microvolts(at follow up (12 months after intake, T2))
研究者
Ann Hallemans
Assistent Professor, Research Group MOVANT, Department of Rehabilitation Sciences and Physiotherapy - Head of the Multidisciplinary Motor Center Antwerp
Universiteit Antwerpen