Ecological Validity of Clinical Gait Analysis in Children With Cerebral Palsy: Influence of the Hawthorne Effect and Dual-tasks. A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Minimal knee flexion during the single support phase
研究概览
简要总结
It is the clinical experience of the authors that some children with cerebral palsy who walk in crouch gait show sufficient knee extension during the clinical gait analysis, but walk in considerable knee flexion when they leave the gait laboratory. Possible differences between walking in a gait lab and walking in daily life may be caused by the effect of observational awareness in the lab (also known as the Hawthorne effect), and the lack of dual-tasks (DT) during the analysis (which are common during daily life walking). Since so far there is no technique to reliably measure gait kinematics in children with CP outside of the laboratory, the researchers aim to objectify the influence of both the Hawthorne effect and dual-tasks by introducing different conditions during a standard clinical 3D gait analysis.
详细描述
Study design: Observational study
Study population: Patients with cerebral palsy, bilateral spastic, knee flexion gait pattern, GMFCS classification I-III, age 4-16 years.
Objective: To determine the effect of observational awareness (the Hawthorne effect) and dual-tasks on spatiotemporal and kinematic variables during a clinical 3D gait analysis.
Primary research question:
Does reduced observational awareness and/or introduction of a dual-task influence knee flexion in stance phase in children with spastic diplegie cerebral palsy and knee flexion gait?
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 4 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cerebral palsy, bilateral spastic, GMFCS classification I-III
- •Age <16 years
- •Use of bilateral AFO's (rigid or ground reaction AFO's) to improve knee extension in stance
排除标准
- •Behavioural issues or poor instructability which might affect participation in the protocol
- •Significant visual disorders
- •Other diagnoses influencing gait
- •Not willing to sign informed consent before inclusion
结局指标
主要结局
Minimal knee flexion during the single support phase
时间窗: Day 1
Minimal knee flexion during the single support phase
次要结局
- Foot to floor angle at initial contact(Day 1)
- Variation of ankle kinematics in stance phase(Day 1)
- Foot to floor angle at moment of minimal knee flexion in single support phase(Day 1)
- Walking speed(Day 1)
- Cadence(Day 1)
- Variation of knee kinematics in stance phase(Day 1)
- Knee flexion at initial contact(Day 1)
- Step length(Day 1)