Upper Limb Rehabilitation Using Virtual Reality in Children With Cerebral Palsy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Slb Pharma
- 入组人数
- 20
- 试验地点
- 6
- 主要终点
- Change in speed and accuracy of movement measured by the " Posting coins item" of the manual dexterity domain on Movement Assessment Battery for Children
研究概览
简要总结
This study aims to evaluate the effect of a virtual reality rehabilitation protocol on visuo-motor coordination and upper limb functional abilities in children with unilateral or bilateral cerebral palsy.
详细描述
Cerebral palsy is the most common cause of motor disability in childhood. Motor disorders result in significant upper limb impairments involving limitations in daily activities. Functional rehabilitation of the upper limb therefore appears to be of primary importance in the management of this condition. However, conventional rehabilitation programs encounter some limitations such as the repetitiveness and the lack of attractivity of the proposed protocols and the poor transfer in activities of daily life. In this context, virtual reality appears as a promising tool to provide more attractive and playful protocols with a better control and a better progressivity in the stages of rehabilitation. However, scientific evidence in this area is still insufficient to define and validate specific and safe rehabilitation programs. The goal of this study is to evaluate the effects of a virtual reality rehabilitation protocol on the improvement of visuo-motor coordination and functional abilities in children with cerebral palsy. This study will include twenty-two children with unilateral or bilateral cerebral palsy who will be randomly divided into two groups: one group receiving three weekly virtual reality rehabilitation sessions for four weeks, in addition to their usual activities, and a control group only following its usual care in the same period (classical rehabilitation). Participants will be randomly matched for age, type of cerebral palsy, (hemiplegia, quadriplegia or monoplegia) and the Manual Ability Classification System (MACS). The effectiveness of the rehabilitation protocol will be evaluated through several tests assessing motor functions of the upper limb. Thus, the visuo-motor coordination, manual dexterity, evolution of joint amplitudes, kinematics of movements and functional use of the affected upper limb in daily tasks will be examined.
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
盲法说明
No Masking
入排标准
- 年龄范围
- 8 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 8 to 16 years old,
- •Diagnosed as spastic, dyskinetic or ataxic cerebral palsy,
- •Diagnosed as hemiplegia, quadriplegia or monoplegia of the upper limb,
- •Child without an intellectual disability or with a mild or moderate disability
- •Ability to understand the task by to follow verbal instructions,
- •Child who has agreed to participate in the study,
- •Child whose parents and/or legal guardians have given their consent for his/her participation in the study
- •Child who can voluntarily move his affected upper limb in a sufficient range of motion
- •Child who is a beneficiary of social security system
排除标准
- •Child with epilepsy
- •Diagnosed as diplegia or monoplegia of lower limb,
- •Severe or profound intellectual disability,
- •Severe attention deficit,
- •Pain on mobilizing upper limb
- •Botulinum toxin injections or surgery on the upper limb within 4 months of the experiment,
- •Health condition not allowing participation in the study protocol,
- •Pregnant participant,
- •Simultaneous participation in another clinical research
结局指标
主要结局
Change in speed and accuracy of movement measured by the " Posting coins item" of the manual dexterity domain on Movement Assessment Battery for Children
时间窗: Pre-test (week 1), post-test (at 6 weeks), 3 months follow-up (at 18 weeks)
The test measures the time needed in seconds to posting 6 coins into a money box with the affected hand. A lower time means a better performance
Change in bimanual coordination measured by the "Threading beads item" of the manual dexterity domain on Movement Assessment Battery for Children
时间窗: Time frame: Pre-test (week 1), post-test (at 6 weeks), 3 months follow-up (at 18 weeks)
The test measures the time needed in seconds to threading 6 beads onto a string. A lower time means a better performance
Change in visuomotor coordination measured by the "Drawing Trail item" of the manual dexterity domain on Movement Assessment Battery for Children
时间窗: Pre-test (week 1), post-test (at 6 weeks), 3 months follow-up (at 18 weeks)
The test measures the number of failures (number of times the boundaries are crossed) performed when tracing a continuous line on a trail. A decrease in the number of failures means a better performance
次要结局
- Intrinsic Motivation Inventory (IMI)(Pre-test ( week 1), post-test (at 6 weeks) and at the sixth session of virtual reality rehabilitation protocol)
- Change on score of Children's Hand-use Experience Questionnaire (27 questions)(Pre-test (week 1), post-test (at 6 weeks) and 3 months follow-up (at 18 weeks))
- Change in performance measured by the "Catching Beanbag item" of the Aiming and Catching domain on Movement Assessment Battery for Children(Pre-test (week 1), post-test (at 6 weeks), 3 months follow-up (at 18 weeks))
- Change in Range of Motion Measurement of upper extremity(Pre-test (week 1), post-test (at 6 weeks) and 3 months follow-up (at 18 weeks))
- Change in target contact time score measured by a visuomotor tracking task performed in virtual reality(Pre-test (week 1), post-test (at 6 weeks), 3 months follow-up (at 18 weeks))
- Change in fluidity of movement score measured by a visuomotor tracking task performed in virtual reality(Pre-test (week 1), post-test (at 6 weeks), 3 months follow-up (at 18 weeks))
- Change in performance on the " Throwing Beanbag on to Mat item" of the Aiming and Catching domain of Movement Assessment Battery for Children(Pre-test (week 1), post-test (at 6 weeks), 3 months follow-up (at 18 weeks))
- Change in manual dexterity measured by the Box and Block Test(Pre-test (week 1), post-test (at 6 weeks), 3 months follow-up (at 18 weeks))
- Change in distance-to-target score measured by a visuomotor tracking task performed in virtual reality(Pre-test (week 1), post-test (at 6 weeks), 3 months follow-up (at 18 weeks))
- Change in movement time score measured by a pointing task performed in virtual reality(Pre-test (week 1), post-test (at 6 weeks), 3 months follow-up (at 18 weeks))
- Change in reaction time score measured by a pointing task performed in virtual reality(Pre-test (week 1), post-test (at 6 weeks), 3 months follow-up (at 18 weeks))
- Change in elbow joint range of motion measured by a visuomotor tracking task performed in virtual reality(Pre-test (week 1), post-test (at 6 weeks), 3 months follow-up (at 18 weeks))