Metrological Properties of a Digital Motion Analysis Research Application for Assessing the Motor Abilities and Performance of Children With Cerebral Palsy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Angle (in degrees) of knee flexion in sagittal view during a two-foot vertical jump using digital motion analysis software
研究概览
简要总结
Cerebral palsy is a common neurological disorder that is the leading cause of motor disability in children. It causes significant motor impairments, affecting various aspects such as fine and gross motor skills, as well as locomotion, which has a major impact on the quality of life of affected children. It is therefore essential to characterize these functional impairments in order to guide clinical decisions and maximize the motor function of affected children.
Currently, the assessment of motor function is based on physical examinations and functional scales, such as the Gross Motor Function Classification System, which is specifically designed to assess children with CP. However, movement analysis using optoelectronic systems is considered the gold standard for this assessment, even though these systems have notable limitations (expensive installation, time-consuming use, and use only in a clinical environment, making it difficult to assess motor skills in children's everyday lives). In order to establish a comprehensive and personalized functional diagnosis, it is crucial to evaluate other fundamental motor tasks such as running, jumping, object control, and balance tasks. Recently, innovative markerless motion analysis technologies have been developed that allow analysis using smartphones or tablets outside of healthcare facilities. Therefore, developing an application dedicated to motion analysis for children with cerebral palsy that is easy to access and can be used frequently could yield many significant benefits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
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
- 是
入选标准
- •Common to both groups:
- •Obtaining free and informed consent from the child and at least one parent
- •Children of all genders aged 6 to 18
- •Children affiliated with or beneficiaries of a social security system
- •For the Cerebral Palsy group:
- •Medical diagnosis of CP according to the SCPE (Surveillance of Cerebral Palsy in Europe) definition;
- •Unilateral and bilateral impairment;
- •Gross Motor Function Classification System (GMFCS) = I to III;
- •No major cognitive or visual impairments that limit the performance of motor tasks
- •For the control group:
- •- Children free from any disease
- •Other volunteers included in the protocol (qualitative analysis only (parents and clinicians)):
- •Parent(s) of children with CP included in this study;
- •Healthcare professionals and researchers involved in monitoring children with CP and/or evaluating the research application within the framework of this study
排除标准
- •Common to both groups:
- •Participants or parent(s) of participants who do not speak French
- •Children subject to legal protection measures
- •Pregnant or breastfeeding participants
- •For the Cerebral Palsy group:
- •Presence of a cause of neuro-orthopedic disorders other than CP
- •Limiting pain
- •Surgical procedures performed less than 6 months prior to inclusion in the study
- •Any other functional medical intervention that took place 3 months prior to inclusion in the study (e.g., botulinum toxin injections, plaster casts, etc.)
- •Medical or surgical interventions planned between visit 1 and visit 2
- •Children with a condition other than cerebral palsy that affects their walking ability
研究组 & 干预措施
Children with a medical diagnosis of cerebral palsy as defined by SCPE
干预措施: Assessment of functional abilities (Other)
Children with a medical diagnosis of cerebral palsy as defined by SCPE
干预措施: Children's self-questionnaires (Other)
Children with a medical diagnosis of cerebral palsy as defined by SCPE
干预措施: Semi-structured interview (Other)
Healthy volunteers
干预措施: Assessment of functional abilities (Other)
Children with a medical diagnosis of cerebral palsy as defined by SCPE
干预措施: Parent self-assessment questionnaires (Other)
结局指标
主要结局
Angle (in degrees) of knee flexion in sagittal view during a two-foot vertical jump using digital motion analysis software
时间窗: Up to 8 months
We will measure the left and right knees, which will be classified as either the most affected lower limb or the least affected lower limb in the PC group.
Angle (in degrees) of knee flexion in sagittal view during a two-foot vertical jump using the Gold Standard system (Motion Capture System).
时间窗: Up to 8 months
We will measure the left and right knees, which will be classified as either the most affected lower limb or the least affected lower limb in the PC group.
次要结局
未报告次要终点
