Effect of Transcranial Direct Current Stimulation Augmented With Activities in Virtual Reality on Functional Recovery of the Upper Extremity of Children With Hemiparesis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- Baseline and post- intervention Fugl-Meyer motor assessment
研究概览
简要总结
Purpose: The aim of the study is to determine the combined effect of transcranial direct current stimulation (tDCS) and activities in virtual reality on the functional recovery of the upper extremity function of the children with hemiparesis. Subjects: Forty children with infantile stroke with age group between (6-12 years) will be divided into two groups, the experimental group will receive tDCS plus VR while the control group will receive sham tDCS plus VR. All the children will receive tDCS for 30minutes with 1.5 mA intensity over the dominant motor cortex. Both groups will be treated for three times a week for 6 weeks. Instrumentation: The the Fugl-Meyer assessment, motricity index, and Modified Barthel index will be used to assess the dependent variables after the intervention.
详细描述
One in 4000 full-term infants develops arterial ischemic stroke at the time of birth.5 These children are commonly called an infantile stroke, infantile hemiplegia, perinatal stroke, and congenital hemiplegic cerebral palsy. Epileptic seizures are common in 24-45 % of children suffering from an infantile stroke within a month.6 Noninvasive brain stimulation (NIBS) is the novel method of delivering therapeutic currents to the brain for the purpose of diagnosis and treatment 7. There is an exponential increase in researches on the effect of NIBS on cognitive deficits. The NIBS has proven to cause neural modulation at the cortical level8. The effect of stimulation is either increased or decreased in neuronal activity, depending on the anodal and cathodal stimulation, firing rate, and period of the activation or inhibition910. There are two types of NIBS techniques safely practiced among humans, these are, Transcranial Magnetic Stimulation (TMS) and Transcranial Direct Current Stimulation (tCDS)11. tCMS uses a weak magnetic field that transforms into beneficial currents into the brain for diagnostic (Single-pulse tCMS) or treatment purposes (repetitive tCMS). The inhibitory or excitatory cortical effects are achieved by decreasing or increasing the frequency and duration of tCMS 12. tCDS involves the use of weak direct or alternating current applied on the scalp via electrodes for the purpose of neural modulation13. The most popular form of tCDS device is a battery-operated stimulator capable of producing direct current ranging from 0.5-2.0 mA14. Neural modulation is achieved by altering the resting membrane potential. The anode causes increased excitability due to its depolarizing effect whereas the cathode electrode causes inhibition due to the hyperpolarization effect14.
Virtual reality (KVR) is the use of a computer interface involving upper limb activity in pediatric rehabilitation. VR creates an artificial environment, presented to the user through appropriate sensory stimulations. Participants use the motion sensor mounted on the paretic hand to interact with the virtual environment. The participants will receive visual and auditory feedback. The purpose of the study is to evaluate the combined effect of virtual reality activities and tDCS on upper limb activity in children with hemiparesis.
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, Care Provider, Investigator)
盲法说明
Children will be randomly allocated to one of the two groups by the lottery method. The researcher involved in randomization will not be involved in the assessment or treatment of the participants. The participants and therapists will also be blinded about the subjects allocated to a group by assigning a unique random number to the participants. Pre and post assessment will be performed by the same therapist. The therapist involved in the treatment is blinded about the treatment received by other groups. Each participant will undergo 3 weeks of treatment, 4 days a week. The total number of treatment sessions for each participant will be 12. Each participant will be assessed on the baseline, 2nd week, 3rd week and on 8th week follow up.
入排标准
- 年龄范围
- 5 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The congenital stroke survivors with mild to moderate degree of upper limb disability on the Brunnstrom recovery scale
- •The scores from 3-4 are considered moderate and 5-6 as a mild degree of upper-limb disability.
- •Age 5-12 years.
- •Able to understand simple commands.
- •Normal vision or with corrected glass
排除标准
- •Hemorrhage in the subarachnoid space
- •Neurosurgery of brain
- •Seizures in the past 12 months.
- •On medication for seizures.
结局指标
主要结局
Baseline and post- intervention Fugl-Meyer motor assessment
时间窗: 8 Months
The Fugl-Meyer motor assessment (FM) will be the primary outcome measure. The scale is a reliable and valid measure for upper limb impairment among stroke patients19. The score ranges from 0-66, score less than 18 are considered severe to moderate functional impairment. The scale takes 20 minutes to complete.
次要结局
- Beiseline and post- intervention Motricity Index(8 Months)
- Baseline and post- intervention Modified Barthel Index(8 Months)
研究者
faizan kashoo, PT
Prinicipal investigator
Majmaah University