Effect of Combined Virtual Reality Therapy and Transcranial Direct Current Stimulation on Children and Adolescents With Cerebral Palsy.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Motor skills improvement
研究概览
简要总结
A double-blinded randomized controlled crossover trial will be conducted, and all participants will undertake non-immersive VR tasks and tDCS-active or tDCS-sham. Group 1 will start with ten sessions of tDSC-active combined to VR tasks. After one-month washout, this group will be reallocated to another 10 sessions with tDCS-sham combined to VR tasks. In contrast, Group 2 will do the opposite protocol (participants will start allocated to ten sessions of TDCS-sham and VR tasks, and after one-month washout period will be reallocated to ten sessions of tDCS-active and VR tasks). All protocol will have the assessment of Autonomic Nervous System, through Heart Rate Variability Analysis.
详细描述
Study design A double-blinded randomized controlled crossover trial will be conducted, and all participants will undertake non-immersive VR tasks and tDCS-active or tDCS-sham. Group 1 will start with ten sessions of tDSC-active combined to VR tasks. After one-month washout, this group will be reallocated to another 10 sessions with tDCS-sham combined to VR tasks. In contrast, Group 2 will do the opposite protocol (participants will start allocated to ten sessions of TDCS-sham and VR tasks, and after one-month washout period will be reallocated to ten sessions of tDCS-active and VR tasks). The one month washout period has been used in some studies and was shown to be enough to reset the effects of the first ten sessions, considering that the motor effects of the tDCS are sustained from two hours to three months.
Participants and sampling Participants will be recruited through referral by the coordinators of two clinics in Brazil: Intensiva and Therapies. Those interested in participating will undergo a detailed screening against the eligibility criteria for enrollment in the study.
Inclusion criteria Participants will be included if they have the agreement to participate in the research conserve, have a clinical diagnosis of CP done by a neuropediatric clinician with non- progressive etiology (with GMFCS levels I and II and MACS I and II), signing the informed consent form by the parents or guardians.
Exclusion criteria Participants will be excluded if they do not understand the tasks. The understanding of the task will be evaluated through five attempts of each task in VR, because even with low IQ a large part of the adolescents can understand virtual tasks and interact with improved performance.
Dropout criteria Participants will be withdrawn from the study if they are not willing to continue their participation, cannot be present on the day of the experiment or miss two treatment section, and/or change their form of rehabilitation during the study.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The device DS-Stimulator, Neuroconn Mobile tDCS allows the blindness of the researcher and the participant, so the participants, researchers, and outcome assessors will remain blind to group allocation during the study. To ensure proper blinding, participants will receive codes and will be concealed from the allocation process by one different researcher. The researchers responsible for applying the intervention and the outcome assessors will not know the study design, allocation, objectives, and expected outcomes. In addition, for the blinding of the experimenter (responsible for applying the intervention), one assessor (responsible for randomization) will be in charge of giving the active device to the experimenter.
入排标准
- 年龄范围
- 5 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Agreement to participate in the research from their selves and their legal guardians (by signing assent form and consent form);
- •Have a clinical diagnosis of CP done by a neuropediatric clinician with non- progressive etiology;
- •GMFCS levels I to IV;
- •MACS I and IV.
排除标准
- •Lack of understanding of the the tasks. The understanding of the task will be evaluated through five attempts of each task in VR, because even with low IQ a large part of the adolescents can understand virtual tasks and interact with improvement of performance;
- •Motor difficulties that impede the completing of the virtual tasks;
- •Cardiac diseases (because of the HRV assessment).
研究组 & 干预措施
tDSC-active
The TDCS-active will be performed over ten consecutive sessions per weekday (i.e. one session daily, no stimulation during the weekend) during the practice of VR games, TDCS-active will be performed with a current of 1 mA and 20 min of duration (20 seconds of ramp-up and ramp-down). The stimulation target will be the M1 area, choosing the more functional side of the participant (C3 or C4).
This group will perform the tDCS-sham after one-month washout.
干预措施: tDSC-active (Device)
tDCS-sham
The TDCS-sham will be performed over ten consecutive sessions per weekday (i.e. one session daily, no stimulation during the weekend). However, the electrodes will be positioned at the same sites of the tDCS-active and the device will be switched on for 20 seconds (with ramp-up and ramp-down), giving the children the initial sensation of the 1 mA current, but with no stimulation administered during the rest of the time. This sham protocol is already programmed in the device prior to data collection.
This group will perform the tDCS-active after one-month washout.
干预措施: tDCS-sham (Device)
结局指标
主要结局
Motor skills improvement
时间窗: 8 weeks.
The motor skills will be analyzed through the games developed specifically for analysis of motor skills, such as (interception skills, speed, accuracy and reaction time).
次要结局
- Heart Rate Variability(8 weeks.)
研究者
Talita Dias da Silva
Principal Investigator
University of Sao Paulo