Virtual Reality Combined With Bobath Therapy for Spastic Cerebral Palsy (NCT07392398) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Virtual Reality Combined With Bobath Therapy for Spastic Cerebral Palsy
China30 participantsStarted 2026-03-01
Plain-language 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.
Who can participate
Age range
2 Years – 14 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Lower Limb Muscle Activity Assessed by Surface Electromyography
Timeframe: Baseline and immediately after 6 weeks of intervention
2
Balance Function Assessed by Center of Pressure Parameters
Timeframe: Baseline and immediately after 6 weeks of intervention
3
Gross Motor Function Measured by the Gross Motor Function Measure-88
Timeframe: Baseline and immediately after 6 weeks of intervention
Trial details
NCT IDNCT07392398
SponsorTongren Hongxin Kangxin Traditional Chinese Medicine Hospital, Guizhou Province