Impact of Somatosensory Intensive Intervention on Motor Performance of the Upper Limb and Participation in Children With Unilateral Cerebral Palsy: a Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Change in Canadian Occupational Performance Measure (COPM).
研究概览
简要总结
This study aims to investigate the effectiveness of an intensive somatosensory intervention in the upper limb of children with hemiparesis regarding structure, function, activity and participation
Hypothesis:
Intensive somatosensory activity based intervention is effective in upper limb and hand ability in children with hemiparesis, specially regarding activity and participation
详细描述
Feasibility and longitudinal study with blinding of the evaluator and the person analyzing the data. The study have 3 procedures:
- - Assessment pre-intervention
- - Intervention: three weeks
- - Assessment post-intervention
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of unilateral cerebral palsy
- •Manual Ability Classification System (MACS): levels I, II y III.
- •Gender: male and female
- •Age: 6 to 15 years old
排除标准
- •Existence of a moderate or severe cognitive impairment, which could interfere with the comprehension of the tester cues
- •Botulinum toxic infiltration 4 months before the date of the pre-intervention assessment or during intervention or during the 3 months after the final intervention
- •To have suffered any injury such as fractures and/or contusions in the upper limb in the last 12 months
- •Orthopedic intervention in the 6 months preceding the study or during the study
研究组 & 干预措施
Somatosensory intensive intervention
干预措施: Somatosensory intensive intervention (Other)
结局指标
主要结局
Change in Canadian Occupational Performance Measure (COPM).
时间窗: baseline, immediately after intervention and follow up (3 months after intervention).
Participation measure (family aims).
Change in Children´s hand-use Experience Questionnaire (CHEQ).
时间窗: baseline, immediately after intervention and follow up (3 months after intervention).
Activity Measure (bimanual performance).
Change in Canadian Occupational Performance Measure (COPM).
时间窗: baseline, immediately after intervention
Participation measure (family aims). Primary outcomes will be reported in separate manuscripts due to scope/space considerations.
Change in Children´s hand-use Experience Questionnaire (CHEQ).
时间窗: baseline, immediately after intervention
Activity Measure (bimanual performance). Primary outcomes will be reported in separate manuscripts due to scope/space considerations.
次要结局
- Change in Pediatric Evaluation of Disability Inventory Computer Adaptive Test (PEDI-CAT).(baseline, immediately after intervention and follow up (3 months after intervention).)
- Change in Box and Blocks Test.(baseline, immediately after intervention and follow up (3 months after intervention).)
- Change in Sensory Profile™ 2 family Questionnaire (Winnie Dunn)(baseline, immediately after intervention and follow up (3 months after intervention).)
- Change in Kidscreen Questionnaire.(baseline, immediately after intervention and follow up (3 months after intervention).)
- Change in Dynamometer (grip strength)(baseline, immediately after intervention and follow up (3 months after intervention).)
- Change in Jebsen Taylor Hand Function Test.(baseline, immediately after intervention and follow up (3 months after intervention).)
- Change in Somatosensory Battery Assessment.(baseline, immediately after intervention and follow up (3 months after intervention).)
- Change in Pinch Gauge (pinch strength).(baseline, immediately after intervention and follow up (3 months after intervention).)
- Change in Pediatric Evaluation of Disability Inventory Computer Adaptive Test (PEDI-CAT).(baseline, immediately after intervention)
- Change in Jebsen Taylor Hand Function Test.(baseline, immediately after intervention)
- Change in Box and Blocks Test.(baseline, immediately after intervention)
- Change in Sensory Profile™ 2 family Questionnaire (Winnie Dunn)(baseline, immediately after intervention)
- Change in Kidscreen Questionnaire.(baseline, immediately after intervention)
- Change in Somatosensory Battery Assessment.(baseline, immediately after intervention)
- Change in Dynamometer (grip strength)(baseline, immediately after intervention)
- Change in Pinch Gauge (pinch strength).(baseline, immediately after intervention)