Effects of Virtual Reality Combined With Bobath Technique on Lower Limb Muscle Activity, Balance, and Motor Function in Patients With Spastic Cerebral Palsy: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Lower Limb Muscle Activity Assessed by Surface Electromyography
研究概览
简要总结
Spastic cerebral palsy is a common neurodevelopmental disorder characterized by increased muscle tone, impaired balance, and limitations in motor function, particularly in the lower limbs. Conventional rehabilitation approaches such as the Bobath technique are widely used to improve posture control and movement patterns; however, patient engagement and task variability may be limited.
This randomized controlled trial aims to evaluate the effectiveness of virtual reality (VR) combined with Bobath therapy on lower limb muscle activity, balance, and gross motor function in patients with spastic cerebral palsy. Eligible participants will be randomly assigned to either a VR plus Bobath intervention group or a conventional Bobath therapy group.
The intervention will be delivered over a 6-week period, with sessions conducted five times per week. Outcome measures, including surface electromyography (sEMG), center of pressure (COP) parameters, and the Gross Motor Function Measure-88 (GMFM-88), will be assessed before and after the intervention. This study seeks to provide evidence on whether integrating VR into conventional rehabilitation can improve functional outcomes in children with spastic cerebral palsy.
详细描述
This study is a prospective, single-center, randomized controlled trial designed to investigate the effects of virtual reality (VR) combined with Bobath therapy on lower limb muscle activity, balance, and motor function in patients with spastic cerebral palsy.
Participants aged 2 to 14 years who are diagnosed with spastic diplegic or hemiplegic cerebral palsy and classified as Gross Motor Function Classification System (GMFCS) levels I to III will be recruited. Eligible participants will be randomly allocated in a 1:1 ratio to either the experimental group or the control group.
The experimental group will receive immersive, task-oriented VR training combined with Bobath neurodevelopmental therapy. The control group will receive conventional Bobath-based rehabilitation without VR components. Both groups will undergo training sessions lasting 40 minutes per session, five sessions per week, for a total duration of 6 weeks. All interventions will be delivered by experienced physical therapists.
Primary outcomes include lower limb muscle activity assessed by surface electromyography (sEMG) of the rectus femoris, biceps femoris, tibialis anterior, and soleus muscles; balance performance evaluated using center of pressure (COP) parameters; and gross motor function measured by the Gross Motor Function Measure-88 (GMFM-88), specifically dimensions D (standing) and E (walking, running, and jumping). Assessments will be conducted at baseline and immediately after completion of the intervention period.
Secondary outcomes may include measures of participation and quality of life. Data will be analyzed using appropriate statistical methods, including repeated measures analysis of variance and covariance analysis, with a significance level set at p < 0.05.
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
- None
入排标准
- 年龄范围
- 2 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 2 to 14 years at the time of enrollment.
- •Diagnosed with spastic cerebral palsy (spastic diplegia or spastic hemiplegia) by a qualified clinician.
- •Classified as Gross Motor Function Classification System (GMFCS) levels I to III.
- •Presence of lower limb spasticity with a Modified Ashworth Scale (MAS) score of at least
- •Ability to understand and follow simple instructions appropriate for age and cognitive level.
- •Written informed consent obtained from a parent or legal guardian.
排除标准
- •Presence of severe cognitive impairment that prevents participation in the intervention or assessments.
- •Uncontrolled epilepsy or a history of frequent seizures that may interfere with the intervention.
- •Severe visual, vestibular, or auditory impairments that limit safe participation in virtual reality training.
- •Orthopedic surgery or botulinum toxin injection involving the lower limbs within the previous 6 months.
- •Participation in other interventional clinical studies during the study period.
研究组 & 干预措施
Virtual Reality Combined With Bobath Therapy
Participants in this arm will receive immersive, task-oriented virtual reality training combined with Bobath neurodevelopmental therapy. The intervention will be delivered by experienced physical therapists for 40 minutes per session, five sessions per week, over a 6-week period.
干预措施: Virtual Reality Combined With Bobath Therapy (Behavioral)
Conventional Bobath Therapy
Participants in this arm will receive conventional Bobath-based neurodevelopmental therapy without virtual reality components. The intervention frequency and duration will be the same as the experimental group, with 40-minute sessions conducted five times per week for 6 weeks.
干预措施: Conventional Bobath Therapy (Behavioral)
结局指标
主要结局
Lower Limb Muscle Activity Assessed by Surface Electromyography
时间窗: Baseline and immediately after 6 weeks of intervention
Lower limb muscle activity will be assessed using surface electromyography (sEMG). The sEMG amplitude and activation patterns of the rectus femoris, biceps femoris, tibialis anterior, and soleus muscles will be recorded during standardized functional tasks.
Balance Function Assessed by Center of Pressure Parameters
时间窗: Baseline and immediately after 6 weeks of intervention
Balance function will be evaluated using center of pressure (COP) measurements obtained from plantar pressure analysis. Static and dynamic balance parameters will be analyzed to assess postural control.
Gross Motor Function Measured by the Gross Motor Function Measure-88
时间窗: Baseline and immediately after 6 weeks of intervention
Gross motor function will be assessed using the Gross Motor Function Measure-88 (GMFM-88). Dimension D (standing) and Dimension E (walking, running, and jumping) scores will be used for analysis.
次要结局
- Overall Quality of Life Score Assessed by PedsQL Total Score(Baseline and immediately after 6 weeks of intervention)
- Domain-Specific Quality of Life Scores Assessed by PedsQL(Baseline and immediately after 6 weeks of intervention)
- Attendance Rate of Scheduled Rehabilitation Sessions(Throughout the 6-week intervention period)
- Completion Rate of the Rehabilitation Program(Throughout the 6-week intervention period)
研究者
Ning Li
Principal Investigator
Tongren Hongxin Kangxin Traditional Chinese Medicine Hospital, Guizhou Province