Tongren Hongxin Kangxin Traditional Chinese Medicine Hospital, Guizhou Province
Phase
Not applicable
Started
2026-03-01
Last updated
2026-02-06
Condition(s) studied
Spastic Cerebral Palsy (sCP)
Investigational drug(s) / intervention(s)
Virtual Reality Combined With Bobath TherapyConventional Bobath Therapy
Virtual 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.
Conventional 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.
Study 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.
Eligibility
Sex
ALL
Min age
2 Years
Max age
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.
Primary outcome measure(s)
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.
Trial sites (1)
Facility
City
Region
Status
Hongxinkang New Traditional Chinese Medicine Hospital, Tongren
Tongren
Guizhou
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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