Transcranial Direct Current Stimulation as Adjuvant to Gamified Rehabilitation for Upper Limb Function in Pediatric Non-progressive Brain Damage: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Changes in Melbourne Assessment 2 (MA-2)
研究概览
简要总结
The goal of this clinical trial is to acknowledge the effects of transcranial direct current stimulation as an adjuvant with gaming rehabilitation for upper limb function rehabilitation in paediatric population with non-progressive brain damage. The main questions it aims to answer are:
- Does tDCS boost upper limb function rehabilitation results adding as an adjuvant in paediatric brain damage?
- What domains related with upper limb function are most influenced by tDCS stimulation?
- What clinical variables are the best to predict the efficacy of the combined treatment?
- If the selected intervention causes changes in cognitive domains, and, if it occurs, see their relationship with the proposed intervention and the motor outcomes.
As a general objective, this trial seeks the validation of a protocol of non-invasive brain stimulation with tDCS as a complementary therapy for peadiatric population with brain injuries.
Participants will be randomly allocated into two groups: experimental group will receive anodal tDCS plus upper limb rehabilitation gaming system rehabilitation and control group will receive sham tDCS plus rehabilitation gaming system for upper limb rehabilitation. Both groups will conducted a virtual reality program with upper limb exercises while been stimulated either with anodal tDCS or sham tDCS.
Researchers will compare experimental and control groups to see if there is a difference in upper limb function and cognitive functions.
详细描述
Paediatric brain damage is categorized into two main types: cerebral palsy, characterized by permanent impairments in posture and movement due to non-progressive brain injuries during gestation and early years of life, and acquired paediatric brain damage, which encompasses sudden brain injuries occurring after birth, stemming from various causes such as traumatic brain injuries, strokes, infections, and brain tumors. Cerebral palsy is estimated to affect 2 cases per 1,000 births, while acquired childhood brain damage exhibits variable incidences depending on the cause. Both categories manifest a broad spectrum of symptoms, ranging from motor and sensory impairments to cognitive, behavioral, and emotional issues, necessitating a transdisciplinary rehabilitation approach. Neuroplasticity has an essential role in function developing and recovery, because of that several rehabilitation techniques are based on this concept, such as virtual reality. Non-invasive brain stimulation is developed to enhance these neuroplasticity mechanisms and, used as a coadjuvant therapy, seeks to get greater and faster results from rehabilitation treatments. Specifically transcranial direct current stimulation (tDCS) has shown positive results in motor functions like gait, balance and upper limb function, when applied as anodal tDCS over M1 cortex. The aim of this study is to conduct an independent parallel randomized trial to assess the effectiveness of tDCS combined with virtual reality in paediatric brain damage in upper limb function, as well as study if the stimulation conducted in M1 cortex has influenced in another cerebral areas and therefore causes changes in cognitive functioning such as executive functions and attention.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Allocation concealment: allocation sequence will be generated by an independent investigator. Group code number will be placed in sealed envelopes, that will be opened by another investigator, ignoring which code corresponds with each intervention.
入排标准
- 年龄范围
- 7 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ischemic or hemorrhagic stroke.
- •Traumatic brain injury.
- •Cerebral palsy.
- •Acquired Brain Injury.
- •Other causes of non-progressive brain damage susceptible to treatment with the established procedures.
- •Evolution of the injury of at least one year.
- •Age between 7 and 15 years, with adequate language development and capacity to comprehend the proposed procedure.
- •Neuroimaging study done.
- •Absence of previous brain injuries prior to the one prompting treatment.
- •Score between II and IV on the MACS scale for manual ability assessment.
- •Signed informed consent by the patient and their legal guardian in case the participant is 12 or older. If the participant is younger than 12 years, only the caregiver signed informed consent will be necessary.
- •Increased tone according to the modified Ashworth scale ranging from 1 to 1+.
- •Minimum score of 1 on each item assessed in the Melbourne Assessment 2 scale.
排除标准
- •Dermatological problems in the electrode application area (psoriasis, dermatitis on the scalp or face).
- •Presence of implants or metal pieces in the head excluding fillings.
- •Pacemakers, medication pumps, stimulators (vagal, cerebral, transcutaneous), ventriculoperitoneal shunts, or aneurysm clips.
- •Neurological disease different from that described in the inclusion criteria.
- •Significant language difficulties that unable proper understanding of activities or severely limit expression.
- •Moderate or severe mood disorders diagnosed by the regular pediatrician.
- •Uncontrolled medical issues (acute phase pathologies without medical or pharmacological treatment with proven efficacy or life-threatening conditions).
结局指标
主要结局
Changes in Melbourne Assessment 2 (MA-2)
时间窗: From baseline at 2 weeks and 6 weeks
Upper limb functionality scale for children with neurological impairment from 2,5 to 15 years. It evaluates range of movement, target accuracy, fluency, grasp, accuracy of release, finger dexterity and speed. These elements are scored separately based on the execution of 16 different activities, giving a 0 to 4 or 0 to 3 punctuation in 36 different items.
Changes in kinematic and kinetic upper limb analysis - Movement acceleration
时间窗: From Baseline at 2 weeks and 6 weeks
The activities included in the MA-2 will be recorded with three different cameras: one in the frontal plane, another in the sagittal plane, and another for the transverse plane. Movement analysis will be carried out with the software kinovea (Kinovea, France). The analysis will include movement acceleration, addressed in meters per second squared (m/s\^2).
Changes in kinematic and kinetic upper limb analysis - range of motion
时间窗: From Baseline at 2 weeks and 6 weeks
The activities included in the MA-2 will be recorded with three different cameras: one in the frontal plane, another in the sagittal plane, and another for the transverse plane. Movement analysis will be carried out with the software kinovea (Kinovea, France). The analysis will include range of motion of flex-extension of shoulder, elbow and wrist; horizontal abduction of the shoulder, radial and cubital deviation of the wrist and abduction and adduction of the shoulder. The markers needed to register the movement will be place according to Wu et al. protocol in sternocostoclavicular joints and xiphoid process for the trunk, acromioclavicular joint for the shoulder, medial and lateral epicondyles for the elbow, radial and ulnar styloid processes for the wrist and heads of the second and fourth metacarpals for the hand. These measures will be addressed in degrees.
Changes in kinematic and kinetic upper limb analysis - Velocity of the movement
时间窗: From Baseline at 2 weeks and 6 weeks
The activities included in the MA-2 will be recorded with three different cameras: one in the frontal plane, another in the sagittal plane, and another for the transverse plane. Movement analysis will be carried out with the software kinovea (Kinovea, France). The analysis will include mean and peak velocity of the movement, addressed in meters per second (m/s).
Changes in kinematic and kinetic upper limb analysis - Duration of the movement
时间窗: From Baseline at 2 weeks and 6 weeks
The activities included in the MA-2 will be recorded with three different cameras: one in the frontal plane, another in the sagittal plane, and another for the transverse plane. Movement analysis will be carried out with the software kinovea (Kinovea, France). The time parameters included in the analyses will be: going phase, adjusting phase, returning phase and total movement duration. All measures will be addressed in seconds (s).
Changes in Box and Block Test (BBT)
时间窗: From baseline at 2 weeks and 6 weeks
This test assesses dexterity. It consists of placing the greater number of cubes from one place to another in 60 seconds.
次要结局
- Changes in Beery-Buktenica Developmental Test of Visual-Motor Integration (Beery VMI)(From baseline at 2 weeks and 6 weeks)
- Changes in Behavior rating inventory for executive function 2 (BRIEF-2)(From baseline at 2 weeks and 6 weeks)
- Changes in Evaluation System for children and adolescents (SENA)(From baseline at 2 weeks and 6 weeks)
- Changes in Kidscreen-52 scale(From baseline at 2 weeks and 6 weeks)
- Changes in Wechsler Intelligence Scale for Children V (WISC-V)(From baseline at 2 weeks and 6 weeks)
- Changes in Neuropsychological battery for children NEPSY-II(From baseline at 2 weeks and 6 weeks)
- Changes in and grip strength(From baseline at 2 weeks and 6 weeks)
- Changes in finger flexor muscles spasticity(From baseline at 2 weeks and 6 weeks)
- Changes in Test of Everyday Attention for Children (TEA-Ch) Changes in Test for everyday attention for children (TEA-Ch)(From baseline at 2 weeks and 6 weeks)
- Changes in finger extensor muscles spasticity(From baseline at 2 weeks and 6 weeks)
- Changes in Children's hand-use experience questionnaire (CHEQ)(From baseline at 2 weeks and 6 weeks)
- Changes in Verbal learning test for children Spain-Complutense (TAVECI)(From baseline at 2 weeks and 6 weeks)