Virtual Reality Combined With Bobath Therapy for Spastic Cerebral Palsy (VR-BOBATH-CP)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Spastic Cerebral Palsy (sCP)
• Intervention / Treatment: Behavioral: Virtual Reality Combined With Bobath Therapy; Behavioral: Conventional Bobath Therapy

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ning Li, PhD; Phone Number: +86 15063406718; Email: lining7718918@163.com

Study Locations

• China
  • Guizhou
    • Tongren, Guizhou, China, 554300
      • Hongxinkang New Traditional Chinese Medicine Hospital, Tongren
      • Contact: Ning Li, PhD; Phone Number: +86 15063406718; Email: lining7718918@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.
Active Comparator: 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.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline and immediately after 6 weeks of intervention
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.	Baseline and immediately after 6 weeks of intervention
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.	Baseline and immediately after 6 weeks of intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Baseline and immediately after 6 weeks of intervention
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.	Baseline and immediately after 6 weeks of intervention
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.	Throughout the 6-week 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.	Throughout the 6-week intervention period

Collaborators and Investigators

• Sponsor: Tongren Hongxin Kangxin Traditional Chinese Medicine Hospital, Guizhou Province
• Investigators: Principal Investigator: Ning Li, Tongren Hongxin Kangxin Traditional Chinese Medicine Hospital, Guizhou Province

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: January 25, 2026
• First Submitted That Met QC Criteria: February 2, 2026
• First Posted (Actual): February 6, 2026

Study Record Updates

• Last Update Posted (Actual): February 6, 2026
• Last Update Submitted That Met QC Criteria: February 2, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Randomized Controlled Trial; Balance Training; Surface Electromyography; Gross Motor Function Measure; Virtual Reality Rehabilitation; Lower Limb Function; Pediatric Rehabilitation; Bobath Technique
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: THKTCMH-VR-BOBATH-CP-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No