Spastic Cerebral Palsy (sCP)
Conditions
Keywords
Virtual Reality Rehabilitation, Bobath Technique, Pediatric Rehabilitation, Lower Limb Function, Balance Training, Surface Electromyography, Gross Motor Function Measure, Randomized Controlled Trial
Brief summary
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.
Detailed description
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. This study aims to provide clinical evidence regarding the potential benefits of integrating virtual reality into conventional Bobath therapy for lower limb rehabilitation in children with spastic cerebral palsy.
Interventions
BEHAVIORALVirtual Reality Combined With Bobath Therapy
Immersive, task-oriented virtual reality training integrated with Bobath neurodevelopmental therapy, delivered by trained physical therapists. Each session will last 40 minutes and will be conducted five times per week for a total duration of 6 weeks.
BEHAVIORALConventional Bobath Therapy
Standard Bobath-based neurodevelopmental therapy provided by experienced physical therapists, without the use of virtual reality. Sessions will last 40 minutes and will be conducted five times per week for a total duration of 6 weeks.
Sponsors
Tongren Hongxin Kangxin Traditional Chinese Medicine Hospital, Guizhou Province
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants will be randomly assigned in a 1:1 ratio to either a virtual reality combined with Bobath therapy group or a conventional Bobath therapy group, and outcomes will be compared between groups after a 6-week intervention period.
Eligibility
Sex/Gender
ALL
Age
2 Years to 14 Years
Healthy volunteers
No
Inclusion criteria
* 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 1. * Ability to understand and follow simple instructions appropriate for age and cognitive level. * Written informed consent obtained from a parent or legal guardian.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lower Limb Muscle Activity Assessed by Surface Electromyography | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Quality of Life Score Assessed by PedsQL Total Score | Baseline and immediately after 6 weeks of intervention | Quality of life will be assessed using the total score of the Pediatric Quality of Life Inventory (PedsQL). |
| Domain-Specific Quality of Life Scores Assessed by PedsQL | Baseline and immediately after 6 weeks of intervention | Domain-specific scores of the Pediatric Quality of Life Inventory (PedsQL), including physical, emotional, social, and school functioning, will be analyzed separately. |
| Attendance Rate of Scheduled Rehabilitation Sessions | Throughout the 6-week intervention period | Attendance rate will be calculated as the proportion of attended sessions out of the total scheduled rehabilitation sessions during the intervention period. |
| Completion Rate of the Rehabilitation Program | Throughout the 6-week intervention period | Completion rate will be defined as the proportion of participants who complete the full 6-week rehabilitation program as scheduled. |
Countries
China
Contacts
CONTACTNing Li, PhD
PRINCIPAL_INVESTIGATORNing Li
Tongren Hongxin Kangxin Traditional Chinese Medicine Hospital, Guizhou Province
Outcome results
None listed