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临床试验/NCT04233710
NCT04233710Unknown2 期

Robotic Rehabilitation and Brain Stimulation for Children With Hemiparetic Cerebral Palsy

University of Calgary2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2019年3月25日最近更新:
适应症

试验速览

阶段
2 期
入组人数
20
试验地点
2
主要终点
Reaching Accuracy

研究概览

简要总结

This study evaluates the use of robotic rehabilitation with and without transcranial direct current stimulation (tDCS) to improve motor performance in children with hemiparetic cerebral palsy. Half of the participants will receive robotic rehabilitation and half will receive robotic rehabilitation with tDCS. We hypothesize that tDCS may augment the robotic therapy and show greater improvements than robotic therapy alone.

详细描述

The defining feature of hemiparetic cerebral palsy is motor impairments primarily on one side of the body. Robotic rehabilitation and non-invasive brain stimulation are both emerging technologies that may be beneficial in improving motor performance in individuals with hemiparetic cerebral palsy. Robotic rehabilitation can allow for hundreds of arm movements in the span of an hour, a level of concentrated repetitions that is not possible in traditional rehabilitation. Additionally, robotics can target specific deficits, such as coordinating both arms together, improving accuracy of reaching movements, or improving proprioception, while simultaneously giving the therapist and patient quantitative feedback on performance. Non-invasive brain stimulation using transcranial direct current stimulation (tDCS) can safely modulate activity in regions of the brain and has emerged as a tool to enhance motor learning in typically developing children and augment therapy in children with hemiparetic cerebral palsy.

Children with hemiparetic cerebral palsy will be randomized to receive robotic rehabilitation with tDCS or robotic rehabilitation with sham-tDCS. Participants and the assessors will be blinded to the treatment. All children will complete 10 sessions within 3 weeks of 1.5 hours of robotic rehabilitation. The Kinarm Exoskeleton Robot will be used and children will play games with their affected arm or both arms to target different aspects of sensorimotor control. Children will simultaneously receive real or sham tDCS for the first 20 minutes of the session. tDCS will consist of 1 mA current with the cathode applied over the contralesional M1 area. All children will be assessed before and after the 10 session intervention period using robotic and clinical measures of motor and sensory performance, and at a 3 month follow up.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
6 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • confirmed diagnosis of hemiparetic cerebral palsy due to unilateral perinatal stroke
  • age 6-18 years
  • Manual Ability Classification System (MACS) Level I-III
  • Modified Ashworth Score in shoulder and elbow <=3;
  • Visual acuity (corrected) better than 20/50 in both eyes
  • able to follow instructions and comply with protocol;
  • able to give consent/assent;
  • able to commit to all assessment and intervention sessions.

排除标准

  • significant contractures in the upper extremity;
  • other neurological conditions or active medical disease;
  • unstable epilepsy;
  • contraindications to tDCS;
  • botulinum toxin A injections in the upper extremity in the past 6 months;
  • upper extremity surgical intervention in past 6 months;
  • involvement in another interventional study.

结局指标

主要结局

Reaching Accuracy

时间窗: change between pre-assessment (within 1 week of starting intervention) and post-assessment (within 1 week of completing intervention)

Change in reaching accuracy as measured by initial direction error on robotic visually guided reaching task.

次要结局

  • Standardized robotic measures of motor and sensory performance(change between pre-assessment (within 1 week of starting intervention) and post-assessment (within 1 week of completing intervention))
  • Assisting Hand Assessment(change between pre-assessment (within 1 week of starting intervention) and post-assessment (within 1 week of completing intervention))
  • Box and Block Assessment(change between pre-assessment (within 1 week of starting intervention) and post-assessment (within 1 week of completing intervention))
  • Purdue Pegboard(change between pre-assessment (within 1 week of starting intervention) and post-assessment (within 1 week of completing intervention))

研究者

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

Dr. Sean Dukelow

Associate Professor

University of Calgary

研究点 (2)

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