Intensive Robotic Rehabilitation in Children With Hemiparesia Using GEOSYSTEM
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Gait speed
研究概览
简要总结
Cerebral palsy is the most frequent motor deficiency in children. Among other, it can leads to spastic diplegia or hemiplegia. Walking abilities is an important skill to the families' point of view in term of independence in curent life. Improving the walking parameters has been the main objective in several studies of rehabilitation. The G-EO system is a last generation robot assisting gait training that can adjust cadence, walk lengh, ankle and hip angles and other walking parameters to movement captation. Its superiority in terms of walking abilities has been demonstrated in adults with stroke sequelae. Only one study was realized in pediatric patients with spastic diplegia with promising results. The investigators hypothesize that intensive robot-assited gait training using the G-EO system in hemiplegic children can improve their walking abilities.
详细描述
Objective :
Primary objective: To evaluate walking velocity with the GRAIL (gait real-time analysis and interactive lab) after intensive robot-assisted gait training using the G-EO system in hemiplegic children.
Secondary objectives :Other parameters that will be evaluate include:
- Endurance on the 6 minute walking test
- Joint angles and muscular contraction on the GRAIL
- Number of steps and travelled distance /24h, cardiac frequency and quality of sleep using actimeter bracelet
- Motor functions using the GMFM (Gross Motor Function Measure)
- Spasticity using the modified Ashworth scale
- The functional independence using the Functional Independence Measure (FIM™) for children,
- The quality of life using the Patient Global Impression (PGI-I)
- Muscular strength using the muscular testing cotation scale
- The musculo-squeletal and adipose composition using the peripherical quantitative computed tomography (pQCT)
- The cerebral area activation using functional MRI Study Type: Controlled randomized pilote study Number of centres: Monocentric study, University hospital of Clermont-Ferrand
Study procedure:
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
- 4 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hemiplegic children aged from 4 to 18 years
- •GMFCS (Gross Motor Function Classification System) score between I and III with lower limb involvement.
- •Children must walk alone with or without aid at least 10 meters, must have acquired sitting position, must be able to understand simple orders to follow the rehabilitation program.
- •Free and informed consent of holders of parental authority and of the patient
- •Affiliated to the social security system
排除标准
- •No lower limb involvement,
- •spasticity = 4 on the modified Ashworth scale,
- •severe cardiorespiratory disease forbidding the rehabilitation program,
- •orthopedic surgery or botulinic toxin injections in the last 6 months before the beginning of the study.
研究组 & 干预措施
Cohort 2 : controle group
3 sessions per week of 30 minutes of classical physiotherapy during two weeks
干预措施: classical physiotherapy (Other)
Cohort 1 : experimental group
5 sessions per week of 30 minutes of robot-assisted rehabilitation with the G-EO system during two weeks
干预措施: Intensive robotic rehabilitation (Other)
结局指标
主要结局
Gait speed
时间窗: day 51
gait speed assessed during a gait assessment session using the GRAIL system
Gait speed
时间窗: day 1
gait speed assessed during a gait assessment session using the GRAIL system
Gait speed
时间窗: day 21
gait speed assessed during a gait assessment session using the GRAIL system
次要结局
- 6 min. walk test (6-WT)(day 51)
- Body composition measurements(day 51)
- quality of sleep: wristband actimeter(day 51)
- number of steps per 24h(day 51)
- motor functions(day 51)
- travelled distance(day 51)
- joint angles(day 51)
- Evaluation of spasticity(day 51)
- functional independence(day 51)
- brain activated areas(day 51)
- cardiac frequency(day 51)
- muscular strength(day 51)
- 6 min. walk test (6-WT)(day 1)
- 6 min. walk test (6-WT)(day 21)
- joint angles(day 1)
- joint angles(day 21)
- number of steps per 24h(day 1)
- number of steps per 24h(day 21)
- travelled distance(day 1)
- travelled distance(day 21)
- quality of sleep: wristband actimeter(day 1)
- quality of sleep: wristband actimeter(day 21)
- cardiac frequency(day 1)
- cardiac frequency(day 21)
- Evaluation of spasticity(day 1)
- Evaluation of spasticity(day 21)
- functional independence(day 1)
- functional independence(day 21)
- motor functions(day 1)
- motor functions(day 21)
- muscular strength(day 1)
- muscular strength(day 21)
- Body composition measurements(day 21)
- brain activated areas(day 21)