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临床试验/NCT04403464
NCT04403464Unknown不适用

The Effect of Using a New Interactive Device Based on Motor Skill Learning Principles on the Motor and Functional Abilities of Children With Bilateral Cerebral Palsy

Université Catholique de Louvain1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年5月26日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
30
试验地点
1
主要终点
Changes in ABILHAND-Kids Questionnaire

研究概览

简要总结

Recent research has shown that interventions with assistive technologies lead to an improvement in the motor and functional abilities of children with cerebral palsy (CP). REAtouch® is a new interactive interface based on motor skill learning principles. Its efficiency during intensive motor skill learning interventions has never been tested in children with bilateral cerebral palsy.

Therefore, the study aims to investigate the efficiency of using a virtual reality tool to provide a motor skill learning intervention in a randomized trial.

详细描述

Recent research has shown that interventions with assistive technologies could lead to an improvement in the motor and functional abilities of children with cerebral palsy (CP). However they usually miss the functional motor skill learning qualities to match the changes observed in high intensity motor skill learning based interventions.REAtouch® is a new interactive interface based on motor skill learning principles that could be implemented in intensive interventions.

Therefore, the study aims to investigate the effects of intensive interventions with or without the interface on the motor and functional abilities of children with bilateral CP.

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 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosed bilateral cerebral palsy,
  • MACS levels from I to III,
  • GMFCS levels from I to III,
  • Ability to follow instructions and complete testing.

排除标准

  • Orthopedic surgery, botulinum toxin injections or another unusual intervention less than 6 months before or within the study period.
  • Unstable seizure
  • Severe visual or cognitive impairments likely to interfere with intervention or testing session completion

研究组 & 干预措施

HABIT-ILE with REAtouch®

Experimental

Hand and Arm Bimanual Intensive Therapy Including Lower Extremities with an interactive device

干预措施: HABIT-ILE with REAtouch® (Behavioral)

HABIT-ILE without REAtouch®

Active Comparator

Hand and Arm Bimanual Intensive Therapy Including Lower Extremities

干预措施: HABIT-ILE without REAtouch® (Behavioral)

结局指标

主要结局

Changes in ABILHAND-Kids Questionnaire

时间窗: pre-camp (1 week before), post-camp (1 week after), 3 months follow- up

This ABILHAND-Kids Questionnaire has been developed to assess a child's unimanual and bimanual upper limb activities. It ranges from - 6 to +6 logits (higher score means better performance).

Changes in Gross Motor Function Measure (GMFM-66):

时间窗: pre-camp (1 week before), post-camp (1 week after), 3 months follow- up

The GMFM has been developed to measure the change in gross motor function over time in children with cerebral palsy.

次要结局

  • Changes in ACTIVLIM-CP Questionnaire(pre-camp (1 week before), post-camp (1 week after), 3 months follow- up)
  • Changes in temporal parameters of the gait (Cycle time)(pre-camp (1 week before), post-camp (1 week after), 3 months follow-up)
  • Changes in 6 Minutes Walking Test (6MWT)(pre-camp (1 week before), post-camp (1 week after), 3 months follow- up)
  • Changes in Jebsen-Taylor Test(pre-camp (1 week before), post-camp (1 week after), 3 months follow- up)
  • Changes in temporal parameters of the gait (Stance time)(pre-camp (1 week before), post-camp (1 week after), 3 months follow-up)
  • Changes in temporal parameters of the gait (Stride)(pre-camp (1 week before), post-camp (1 week after), 3 months follow-up)
  • Changes in Executive Functions(pre-camp (1 week before), post-camp (1 week after), 3 months follow-up)
  • Changes in temporal parameters of the gait (Velocity)(pre-camp (1 week before), post-camp (1 week after), 3 months follow-up)
  • Changes in spatial parameters of the upper extremity (Smoothness)(pre-camp (1 week before), post-camp (1 week after), 3 months follow-up)
  • Changes in Test of Arm Selective Control (TASC)(pre-camp (1 week before), post-camp (1 week after), 3 months follow- up)
  • Changes in Selective Control Assessment of the Lower Extremity (SCALE)(pre-camp (1 week before), post-camp (1 week after), 3 months follow- up)
  • Changes in Box and Blocks test (BBT)(pre-camp (1 week before), post-camp (1 week after), 3 months follow- up)
  • Changes in Modified Cooper test(pre-camp (1 week before), post-camp (1 week after), 3 months follow- up)
  • Changes in ABILOCO-Kids Questionnaire(pre-camp (1 week before), post-camp (1 week after), 3 months follow- up)
  • Changes in Pediatric Evaluation of Disability Inventory Computer Adaptive Test (PEDI-CAT)(pre-camp (1 week before), post-camp (1 week after), 3 months follow- up)
  • Changes in Canadian Occupational Performance Measure (COPM)(pre-camp (1 week before), post-camp (1 week after), 3 months follow- up)
  • Changes in spatial parameters of the upper extremity (Straightness)(pre-camp (1 week before), post-camp (1 week after), 3 months follow-up)
  • Changes in temporal parameters of the upper extremity (Kinematics assessments)(pre-camp (1 week before), post-camp (1 week after), 3 months follow-up)
  • Changes in Both Hands Assessment (BoHA)(pre-camp (1 week before), post-camp (1 week after), 3 months follow- up)
  • Changes in spatial parameters of the gait (Kinematics assessments)(pre-camp (1 week before), post-camp (1 week after), 3 months follow-up)
  • Changes in temporal parameters of the gait (Swing time)(pre-camp (1 week before), post-camp (1 week after), 3 months follow-up)
  • Changes in temporal parameters of the gait (Acceleration)(pre-camp (1 week before), post-camp (1 week after), 3 months follow-up)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yannick Bleyenheuft

Professor

Université Catholique de Louvain

研究点 (1)

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