Augmented Effects of Virtual-reality Cycling Training on Upper Limb Motor Functions by Noninvasive Brain Stimulation in Patients With Cerebral Palsy
概览
- 阶段
- 不适用
- 干预措施
- Transcranial electric stimulation
- 疾病 / 适应症
- Cerebral Palsy
- 发起方
- Chang Gung Memorial Hospital
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Change from baseline Goal Attainment Scale at after six weeks of treatment and three month
- 状态
- 已完成
- 最后更新
- 3个月前
概览
简要总结
Cerebral palsy (CP) is the most common childhood motor disability. Weakness, spasticity, and loss of dexterity are the major problems in patients with CP. A novel virtual-reality cycling training (VCT) program was to enhance promising muscle strength and motor function through promoting the participant compliance and motivation. Non-invasive brain stimulation (NIBS), such as repetitive transcranial magnetic stimulation (rTMS) and transcranial electric stimulation (TES) has potential to augment the training effects in motor neurorehabilitation via the modulation on neuroplasticity. Therefore, this study propose a novel intervention protocol to induce superior benefits on upper extremity (UE) motor function in patients with CP.
详细描述
This study aims to investigate the augmented effects of VCT on neuromotor control and UE motor function by NIBS in patients with CP. We hypothesize that NIBS can augment the VCT effects on neuromotor control and UE motor function in patients with CP because combined therapy integrated peripheral modification techniques (VCT) and central modulation (NIBS). These effects may further enhance the activity of daily living (ADL), participation, and health related quality of life (HRQOL). This project is executed in the following two phases: to investigate the augmented effects of VCT on neuromotor control and UE motor function in patients with CP by rTMS in phase 1 (0-1.5 years) and tCS in phase 2 (1.5-3 years).
研究者
入排标准
入选标准
- •Diagnosis of CP according to clinical criteria
- •Age 5-20 years
- •No use of botulinum toxin in the past 4 months
- •No significant perceptual or communication disturbances
- •No other peripheral or central nervous system dysfunction
- •No active inflammatory or pathologic changes in upper limb joints during the previous 6 months
- •No active medical problems, such as pneumonia, upper gastrointestinal bleeding, or urinary tract infection
- •No active problems of epilepsy and EEG without epileptiform discharge
排除标准
- •Metabolic disorders, such as inborn error of metabolism, electrolyte, and endocrine disorders
- •Active infectious disease, such as meningitis and encephalitis
- •Patients with active medical problems, such as pneumonia, upper gastrointestinal bleeding, or urinary tract infection
- •Poor compliance or intolerance for the TMS therapy
- •Subjects with metallic implants or pregnancy.
- •EEG show epileptiform discharge
- •Patients with family history of epilipsy
- •Patients with symptoms that are restricted from tDCS, such as epilepsy, migraine and unstable health condition
研究组 & 干预措施
real TES
In transcranial electric stimulation group (TES group), they received TES stimulation over motor cortex.
干预措施: Transcranial electric stimulation
VCT and real rTMS
In virtual cycling training and intermittent theta burst stimulation group (VCT + iTBS group), they received VCT and iTBS (80% of active motor threshold) on affected hemisphere.
干预措施: Virtual cycling training
VCT and real rTMS
In virtual cycling training and intermittent theta burst stimulation group (VCT + iTBS group), they received VCT and iTBS (80% of active motor threshold) on affected hemisphere.
干预措施: Repetitive transcranial magnetic stimulation
VCT and sham rTMS
In virtual cycling training and sham theta burst stimulation group (VCT + iTBS group), they received VCT and sham TBS stimulation.
干预措施: Virtual cycling training
VCT and sham rTMS
In virtual cycling training and sham theta burst stimulation group (VCT + iTBS group), they received VCT and sham TBS stimulation.
干预措施: Repetitive transcranial magnetic stimulation
real rTMS
In intermittent theta burst stimulation (iTBS group), they received iTBS (80% of active motor threshold) on affected hemisphere.
干预措施: Repetitive transcranial magnetic stimulation
sham rTMS
In sham theta burst stimulation (sham TBS group), they received sham TBS stimulation.
干预措施: Repetitive transcranial magnetic stimulation
VCT and real TES
In virtual cycling training and transcranial electric stimulation group (VCT + TES group), they received TES stimulation over motor cortex.
干预措施: Virtual cycling training
VCT and real TES
In virtual cycling training and transcranial electric stimulation group (VCT + TES group), they received TES stimulation over motor cortex.
干预措施: Transcranial electric stimulation
VCT and sham TES
In virtual cycling training and sham transcranial electric stimulation group (VCT + sham TES group), they received VCT and sham TES stimulation.
干预措施: Virtual cycling training
VCT and sham TES
In virtual cycling training and sham transcranial electric stimulation group (VCT + sham TES group), they received VCT and sham TES stimulation.
干预措施: Transcranial electric stimulation
sham TES
In sham transcranial electric stimulation group (sham TES group), they received sham TES stimulation.
干预措施: Transcranial electric stimulation
结局指标
主要结局
Change from baseline Goal Attainment Scale at after six weeks of treatment and three month
时间窗: baseline, after 6 weeks of treatment, 3 months
Goal Attainment Scale (GAS) is used to help a person with cerebral palsy and their family develop personal goals for therapy (for each item minimum value is -2 and maximum value is 2, higher scores mean a better outcome).
Change from baseline Bruininks- Oseretsky Test of Motor Proficiency II at after six weeks of treatment and three month
时间窗: baseline, after 6 weeks of treatment, 3 months
The Bruininks- Oseretsky Test of Motor Proficiency II (BOT-2) provides an overview of fine and gross motor skills in children and school-aged adolescents.
次要结局
- Change from baseline Myoton at after six weeks of treatment and three month(baseline, after 6 weeks of treatment, 3 months)
- Change from baseline Box and block test at after six weeks of treatment and three month(baseline, after 6 weeks of treatment, 3 months)
- Change from baseline Pediatric Motor Activity Log at after six weeks of treatment and three month(baseline, after 6 weeks of treatment, 3 months)
- Change from baseline ABILHAND Questionnaire at after six weeks of treatment and three month(baseline, after 6 weeks of treatment, 3 months)
- Change from baseline Assessment of Preschool Children's Participation at after six weeks of treatment and three month(baseline, after 6 weeks of treatment, 3 months)
- Change from baseline Hand dynamometer at after six weeks of treatment and three month(baseline, after 6 weeks of treatment, 3 months)
- Change from baseline Melbourne Assessment 2 at after six weeks of treatment and three month(baseline, after 6 weeks of treatment, 3 months)
- Change from baseline Nine-Hole test at after six weeks of treatment and three month(baseline, after 6 weeks of treatment, 3 months)
- Change from baseline Children Assessment of Participation and Enjoyment at after six weeks of treatment and three month(baseline, after 6 weeks of treatment, 3 months)
- Change from baseline Cerebral Palsy Quality of Life at after six weeks of treatment and three month(baseline, after 6 weeks of treatment, 3 months)
- Change from baseline Motor Evoked Potential at after six weeks of treatment and three month(baseline, after 6 weeks of treatment, 3 months)
- Change from baseline Motion analysis at after six weeks of treatment and three month(baseline, after 6 weeks of treatment, 3 months)
- Change from baseline Quality of upper extremity skills test at after six weeks of treatment and three month(baseline, after 6 weeks of treatment, 3 months)
- Change from baseline Functional Independence Measure at after six weeks of treatment and three month(baseline, after 6 weeks of treatment, 3 months)