Spastic Cerebral Palsy (sCP)VR-BOBATH-CPNCT07392398
Virtual Reality Combined With Bobath Therapy for Spastic Cerebral Palsy
A study testing Virtual Reality Combined With Bobath Therapy and Conventional Bobath Therapy in people with Spastic Cerebral Palsy (sCP), run by Tongren Hongxin Kangxin Traditional Chinese Medicine Hospital, Guizhou Province at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 14 years
- Conditions the study is for
- Spastic Cerebral Palsy (sCP)
- What is being tested?
- Virtual Reality Combined With Bobath Therapy and Conventional Bobath Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2026to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Hongxinkang New Traditional Chinese Medicine Hospital, Tongren
Tongren, Guizhou, 554300
Ning Li, PhD, +86 15063406718, lining7718918@163.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Spastic Cerebral Palsy (sCP)
- Being tested
- Virtual Reality Combined With Bobath Therapy, Conventional Bobath Therapy
- Keywords
- Virtual Reality Rehabilitation, Bobath Technique, Pediatric Rehabilitation, Lower Limb Function, Balance Training, Surface Electromyography, Gross Motor Function Measure, Randomized Controlled Trial
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality Combined With Bobath TherapyBehavioural
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 TherapyBehavioural
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Conventional Bobath Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline and immediately after 6 weeks of intervention
Secondary outcomes (4)
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Throughout the 6-week intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study start1 Mar 2026 (estimated)
- Primary completion1 May 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spastic Cerebral Palsy (sCP)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongren Hongxin Kangxin Traditional Chinese Medicine Hospital, Guizhou Province
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ning Li, Tongren Hongxin Kangxin Traditional Chinese Medicine Hospital, Guizhou Province
- Investigators
- Ning Li, Principal investigator, Tongren Hongxin Kangxin Traditional Chinese Medicine Hospital, Guizhou Province
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07392398
- Sponsor's protocol ID
- THKTCMH-VR-BOBATH-CP-01
- Acronym
- VR-BOBATH-CP
- Status last verified
- Feb 2026
- First submitted
- 25 Jan 2026
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07392398
- Acronym / sponsor ID
- VR-BOBATH-CP / THKTCMH-VR-BOBATH-CP-01
- 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
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Tongren Hongxin Kangxin Traditional Chinese Medicine Hospital, Guizhou ProvinceUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 6 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Combined With Bobath Therapy | Experimental | Behavioral: Virtual Reality Combined With Bobath TherapyParticipants 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. |
| Conventional Bobath Therapy | Active comparator | Behavioral: Conventional Bobath TherapyParticipants 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. |
Who may qualify
- Ages
- 2 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality Combined With Bobath TherapyImmersive, 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. | Behavioural | Virtual Reality Combined With Bobath Therapy |
| Conventional Bobath TherapyStandard 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. | Behavioural | Conventional Bobath Therapy |
Primary outcome
Lower Limb Muscle Activity Assessed by Surface Electromyography
Time frame: 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
Time frame: 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
Time frame: 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.
4 secondary outcomes
Overall Quality of Life Score Assessed by PedsQL Total Score
Time frame: Baseline and immediately after 6 weeks of intervention
Domain-Specific Quality of Life Scores Assessed by PedsQL
Time frame: Baseline and immediately after 6 weeks of intervention
Attendance Rate of Scheduled Rehabilitation Sessions
Time frame: Throughout the 6-week intervention period
Completion Rate of the Rehabilitation Program
Time frame: Throughout the 6-week intervention period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ning Li principal investigator
Tongren Hongxin Kangxin Traditional Chinese Medicine Hospital, Guizhou Province
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Combined With Bobath Therapy and Conventional Bobath Therapy in people with Spastic Cerebral Palsy (sCP), run by Tongren Hongxin Kangxin Traditional Chinese Medicine Hospital, Guizhou Province at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ning Li, PhD (+86 15063406718, lining7718918@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lower Limb Muscle Activity Assessed by Surface Electromyography (time frame: Baseline and immediately after 6 weeks of intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.