Virtual Reality Combined With Bobath Therapy for Spastic Cerebral Palsy

NCT07392398 | Not Yet Recruiting

• 1 other identifier: THKTCMH-VR-BOBATH-CP-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Spastic Cerebral Palsy (sCP)

Keywords

Virtual Reality Rehabilitation; Bobath Technique; Pediatric Rehabilitation; Lower Limb Function; Balance Training; Surface Electromyography; Gross Motor Function Measure; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Overall Quality of Life Score Assessed by PedsQL Total Score

  Baseline and immediately after 6 weeks of intervention

• Domain-Specific Quality of Life Scores Assessed by PedsQL

  Baseline and immediately after 6 weeks of intervention

• Attendance Rate of Scheduled Rehabilitation Sessions

  Throughout the 6-week intervention period

• Completion Rate of the Rehabilitation Program

  Throughout the 6-week intervention period

Study Arms (2)

Virtual Reality Combined With Bobath Therapy

EXPERIMENTAL

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

Conventional Bobath Therapy

ACTIVE COMPARATOR

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

Interventions

Conventional Bobath Therapy BEHAVIORAL

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.

Conventional Bobath Therapy

Virtual Reality Combined With Bobath Therapy BEHAVIORAL

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.

Virtual Reality Combined With Bobath Therapy

Eligibility Criteria

• Age: 2 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tongren Hongxin Kangxin Traditional Chinese Medicine Hospital, Guizhou Province: lead

Study Sites (1)

Hongxinkang New Traditional Chinese Medicine Hospital, Tongren

Tongren, Guizhou, 554300, China

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Ning Li

  Tongren Hongxin Kangxin Traditional Chinese Medicine Hospital, Guizhou Province

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ning Li, PhD

CONTACT

+86 15063406718; lining7718918@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: January 25, 2026
• First Posted: February 6, 2026
• Study Start: March 1, 2026
• Primary Completion: May 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: February 6, 2026

Record last verified: 2026-02

Locations

CN (1)