Effectiveness of Virtual Reality on Functional Mobility During Treadmill Training in Children With Cerebral Palsy: a Randomized Clinical Trial (VirtWalkCP Project)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Functional mobility change
研究概览
简要总结
Cerebral palsy (CP), which occurs as a consequence of brain damage, has multiple deficits such as a global reduction of motor cortical activity during movement execution and inadequate processing of corticospinal and somatosensory circuits. Global registers estimate that it occurs in two to three of 1.000 live births, and spasticity is the most common disorder, occurring in 80% of children with CP. Spasticity might affect both upper and lower limbs, resulting in other deficits in joint mobility, postural reactions, selective motor control, balance, and gait. This set of impairments and deficits may lead to limitations in functional ability and autonomy in the performance of daily living activities, physical fitness, quality of life, and/or ability to participate in games and sports activities compared to neurotypical peers of the same age.
Walking is considered one of the most important activities in daily life, as it is essential for activities of daily living and social participation. Children with Gross Motor Function Classification System (GMFCS) levels I, II, and III show potential for walking, and around 75% of CP children are ambulatory. However, abnormalities in neural control and muscle weakness contribute to several gait characteristics such as slow velocity, decreased stride length, increased stance phase percentage, and increased peak ankle dorsiflexion and knee flexion, and peak hip extension moments. Consequently, this gait pattern contributes to postural instability and increased fall risk in children with CP, among others.
详细描述
The main objective of the present study is to evaluate the effectiveness of treadmill gait training and virtual reality comparing to treadmill gait training on functional mobility in infants with spastic cerebral palsy.
The study design is a two-arm randomized clinical trial, single-center and single-blind (evaluators). The sample will be recruited at the Hospital General de Vic, and the study will be conducted at the Universitat de Vic - Universitat Central de Catalunya (UVic-UCC).
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Medical diagnosis of spastic cerebral palsy
- •Motor function levels I to III according to the Gross Motor Function Classification System
- •Independent walking was acquired for more than 12 months.
- •Able to ambulate for at least 10 meters with or without aids.
排除标准
- •Orthopaedic surgery on the lower limbs in the past 12 months.
- •Scheduled surgery during the period of the study.
- •Orthopaedic deformities with surgery indication.
- •Uncontrolled seizure disorder.
- •Metallic implant in the skull.
- •Hearing aid.
- •Have received toxic botulin injections in the past 6 months.
- •Significant cognitive or visual impairment.
结局指标
主要结局
Functional mobility change
时间窗: Basal assessment, at the end of the intervention (an average of 3 weeks), 1 month after the end of the intervention (an average of 8 weeks).
The 6-Minute Walk Test (6MWT) will be performed according to the recommendations. The test will be performed once in a 10m course layout. Participants will receive standardized instructions and encouragement. The test-retest interclass correlation coefficient of this test is 0.98. The estimated time to perform the test is 10 minutes.
次要结局
- Static balance(Basal assessment, at the end of the intervention (an average of 3 weeks), 1 month after the end of the intervention (an average of 8 weeks))
- Walking speed(Basal assessment, at the end of the intervention (an average of 3 weeks), 1 month after the end of the intervention (an average of 8 weeks))
- Dynamic balance(Basal assessment, at the end of the intervention (an average of 3 weeks), 1 month after the end of the intervention (an average of 8 weeks))
- Gross motor function(Basal assessment, at the end of the intervention (an average of 3 weeks), 1 month after the end of the intervention (an average of 8 weeks))
- Functional independence(Basal assessment, at the end of the intervention (an average of 3 weeks), 1 month after the end of the intervention (an average of 8 weeks))
- Health-related quality of life(Basal assessment, at the end of the intervention (an average of 3 weeks), 1 month after the end of the intervention (an average of 8 weeks))
- Occupational participation(Basal assessment, at the end of the intervention (an average of 3 weeks), 1 month after the end of the intervention (an average of 8 weeks))
研究者
Mirari Ochandorena Acha
Associate professor
University of Vic - Central University of Catalonia