My Scrivener® - Measuring Effectiveness and Dose Response in Children
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 176
- 试验地点
- 2
- 主要终点
- Beery Motor Coordination Subtest
研究概览
简要总结
This study will assess whether a computer haptic peripheral device programmed to provide repetitive motion training is as effective as the same repetitive motion training provided by a human being.
详细描述
This study builds on a large body of neurological research that uses robot-guided repetitive motion training to induce neuroplasticity and improvements in upper extremity motor skills in adults and children. This research study is looking at handwriting, a fine-motor task that is used daily.
In our study, we want to see if 3-dimensional robotic-assisted repetitive motion training can be a safe and effective intervention for school-age children with fine motor deficits arising from several different impairment origins. Our research construct is: Legible handwriting = function of (tactile feedback, visual feedback, duration, and fine-motor control).
Independent variables:
- Tactile feedback is a continuous variable of force-feedback measured in pounds of force.
- Duration is a continuous variable measured in seconds and number of repetitions.
- Visual feedback is the letter scribed on the paper.
Dependent variable:
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
- 5 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet the following base prerequisites for writing: orientation to written language; eye-hand coordination, single handed utensil or tool manipulation (BAMF score >= 6), recognize all letters of the alphabet (unless the child has dyslexia).
- •Children have illegible printing for their grade, or legible printing but a speed less than the norms for their grade and sex.
- •Be able to grasp a pen.
- •Be able to speak and understand English.
- •Be able to follow instructions.
- •Be able to devote at least 20 minutes to the assigned tasks (short breaks will be allowed).
- •Be enrolled in school at grade K or above.
- •A score lower than 80% on the Print Tool™ or the Cursive Tool.
排除标准
- •Unable to pass the informed assent screener.
- •Unwilling to sign or mark the informed assent documents.
- •Uncontrolled spasticity.
- •A BAMF score lower than 6 (includes severe paralysis of the upper extremity).
- •Cerebral palsy other than hemiplegia cerebral palsy
- •Severe autism or intellectual disabilities that prevent productive interactions with the investigator
结局指标
主要结局
Beery Motor Coordination Subtest
时间窗: after 20 interventions
Print Tool and Cursive Tool
时间窗: after 20 interventions
Deviations from desired 3-D writing path
时间窗: after 5, 10, 15, 20 interventions
次要结局
- Brief Assessment of Fine Motor Skills(after 20 interventions)