About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
Virtual Reality Combined With Bobath Therapy
BehavioralImmersive, 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.
Conventional Bobath Therapy
BehavioralStandard 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.
Treatment groups
Trial outcomes
Primary outcomes
Lower Limb Muscle Activity Assessed by Surface Electromyography
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
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
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 outcomes
Overall Quality of Life Score Assessed by PedsQL Total Score
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
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
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
Completion rate will be defined as the proportion of participants who complete the full 6-week rehabilitation program as scheduled.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: