Transcranial Direct-Current Stimulation (tCDS) and Robotics for Children With Hemiplegia
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in Assisting Hand Assessment after intervention
研究概览
简要总结
Hemiplegia occurs when the function of motor areas in the brain become impaired, predominantly unilaterally, during perinatal development. Children with hemiplegia show impairments in motor control of the affected side of the body. Impairments in use of the upper extremity are common, and lead to functional disability throughout the lifespan of a person with hemiplegia. Upper extremity impairments can severely affect a person's ability to carry out activities of daily living.
The goal of this study at Blythedale Children's Hospital is to test the efficacy of transcranial direct current stimulation (tDCS) and robotic upper extremity therapy in improving upper extremity function in children with unilateral cerebral palsy. This study will test the hypothesis that physical rehabilitation, provided by repetitive arm movements guided by a robot, will improve upper extremity function in children with hemiplegia, and that this improvement can be enhanced by transcranial direct current stimulation of motor cortex immediately before robotic training.
详细描述
This sham-controlled, double-blind study will be completed at Blythedale Children's Hospital.
Detailed procedures
Robotic Device and Patient Position
The investigators will use existing robots at Blythedale, which are FDA approved robotic devices that move the shoulder-and-elbow, or wrist-and-forearm, or the Typo Amadeo digit training robot.
All robots: The subject will sit in a foam-padded chair facing the robot and a video screen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
tDCS will be blinded in that even children in the sham group will receive a low level of stimulation for a brief period.
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant and caregiver willing and able to provide informed consen/assent
- •Diagnosis of hemiplegia
- •Joint mobility: wrist extension, 20º, metacarpophalangeal and proximal interphalangeal joints 10º
排除标准
- •Cognitive deficits that impede understanding of study protocol
- •Current medical illness unrelated to CP
- •Visual problems (uncorrected by glasses/contact lenses)
- •High motor ability in affected arm Pre-intervention screening measures; Motor activity log, score > 2.5 ( > slight-to-moderate)
- •Severe spasticity Pre-intervention screening measures; Modified Ashworth test, score > 3 ( > moderate)
- •Lack of asymmetry in hand function
- •Orthopedic surgery in affected arm within 2 years
- •Dorsal root rhizotomy
- •Botulinum toxin therapy in either upper extremity during last 2 months, or planned during study period
- •Currently receiving intrathecal baclofen
- •Seizure beyond age 2, use of anti-seizure medication, history of epilepsy (in self or first degree relatives), brain surgery, cranial metal implants, structural brain lesion, devices that may be affected by TMS (pacemaker, medication pump, cochlear implant, implanted brain stimulator)
- •True positive response on the Transcranial Magnetic Stimulation Safety Screen
- •Current use of medications known to lower the seizure threshold
- •Previous episode of neurocardiogenic syncopy
研究组 & 干预措施
Real tDCS plus robotic training
Children will receive 20 min of real tDCS stimulation per session, followed by robotic training for 1 hr.
干预措施: tDCS plus robotic training (Other)
Sham tDCS plus robotic training
Children will receive 20 min of sham tDCS stimulation per session, followed by robotic training for 1 hr.
干预措施: tDCS plus robotic training (Other)
结局指标
主要结局
Change in Assisting Hand Assessment after intervention
时间窗: Within one week after the intervention ends
Assessment of how well children incorporate both hands into bimanual task performance, using an assessment tool called the "Assisting Hand Assessment"
Change in Jebsen-Taylor Test of Hand Function after intervention
时间窗: Within one week after the intervention ends
Assessment of unimanual movement speed
Change in Box and blocks test after intervention
时间窗: Within one week after the intervention ends
Assessment of unimanual function
次要结局
未报告次要终点
研究者
Kathleen Friel
Director, Cerebral Palsy Research
Blythedale Children's Hospital