Effects of Transcranial Direct Current Stimulation Combined With Virtual Reality on Balance and Executive Functions in Children With Spastic Diplegic Cerebral Palsy
Effects of Transcranial Direct Current Stimulation in Addition to Virtual Reality on Balance and Executive Functions in Children With Spastic Diplegic Cerebral Palsy: A Randomized Controlled Trial
Children with spastic diplegic cerebral palsy commonly experience difficulties with balance and may also have challenges involving attention, working memory, cognitive flexibility, and inhibitory control. Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation technique that may influence motor-cortical excitability, while virtual reality (VR) rehabilitation provides repetitive, interactive, and task-oriented training.
This randomized controlled trial will investigate whether active tDCS combined with VR rehabilitation improves balance and executive functions more than sham tDCS combined with the same VR rehabilitation or conventional physical therapy in children with spastic diplegic cerebral palsy.
A total of 42 children aged 8 to 16 years with Gross Motor Function Classification System (GMFCS) levels I-III will be randomly assigned in a 1:1:1 ratio to active tDCS plus VR, sham tDCS plus VR, or conventional physical therapy. Participants will complete 18 treatment sessions over six weeks, with three sessions per week.
Outcomes will be assessed at baseline, after nine treatment sessions, and after 18 treatment sessions. Balance will be evaluated using the Pediatric Balance Scale and Functional Reach Test. Executive functions will be assessed using the Trail Making Test, Stroop Test, and Digit Span. Lower-limb spasticity will be evaluated using the Modified Tardieu Scale.
Study Overview
Status
Conditions
Detailed Description
This study is a three-arm, parallel-group, randomized controlled trial designed to evaluate the effects of active transcranial direct current stimulation (tDCS) combined with virtual reality (VR) rehabilitation on balance and executive functions in children with spastic diplegic cerebral palsy. The active intervention will be compared with sham tDCS combined with the same VR rehabilitation and with conventional physical therapy.
Forty-two children aged 8-16 years with spastic diplegic cerebral palsy and Gross Motor Function Classification System (GMFCS) levels I-III will be enrolled and randomly allocated in a 1:1:1 ratio, with 14 participants in each intervention arm. Outcome assessment will be performed by an assessor blinded to group allocation.
Participants in the active tDCS plus VR group will receive transcranial direct current stimulation at an intensity of 1 mA for 20 minutes per session using saline-soaked sponge electrodes, together with structured VR rehabilitation. The stimulation montage will target the lower-limb motor cortical region with a supraorbital reference electrode. Participants in the sham tDCS plus VR group will receive the same electrode setup and VR rehabilitation programme; sham stimulation will be delivered for the initial 30 seconds to reproduce the early sensory experience of active stimulation without continued therapeutic stimulation.
VR rehabilitation will include progressively challenging activities targeting postural control, balance, movement coordination, obstacle navigation, dual-task performance, visual attention, and cognitive-motor integration. Participants in the conventional physical therapy group will receive a structured rehabilitation programme incorporating lower-limb stretching, strengthening, balance training, gait-related activity, motor-control exercises, and progressive functional mobility training.
All groups will receive 18 sessions over six weeks at a frequency of three sessions per week. Assessments will be conducted before treatment at baseline (S0), after nine treatment sessions at the midpoint of the programme (S9), and after completion of 18 sessions (S18).
Balance outcomes will include the Pediatric Balance Scale and Functional Reach Test. Executive-function outcomes will include Trail Making Test measures of processing speed and cognitive flexibility, Stroop Test measures of inhibitory control and interference processing, and Digit Span measures of attention and working memory. Lower-limb spasticity will be assessed using the Modified Tardieu Scale as a secondary impairment-level outcome.
The study is intended to determine whether active tDCS provides an additional therapeutic effect when combined with VR beyond the effects of matched VR with sham stimulation, while also comparing the combined technology-assisted rehabilitation approach with conventional physical therapy.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: hassan rauf, MS PEDIATRIC PHYSICAL THERAPY
- Phone Number: +923161504297
- Email: hassanrauf507@gmail.com
Study Locations
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Islamabad, Pakistan, 44000
- Recruiting
- Al-Farabi Special Education Centre for Physically Handicapped
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Contact:
- hassan rauf, MS PEDIATRIC PHYSICAL THERAPY
- Email: hassanrauf507@gmail.com
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Islamabad, Pakistan, 44000
- Recruiting
- Sedum School of Rehabilitation
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Contact:
- hassan rauf, MS PEDIATRIC PHYSICAL THERAPY
- Phone Number: +923161504297
- Email: hassanrauf507@gmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Diagnosed with spastic cerebral palsy (spastic diplegia). Age 8-16 years. Gross Motor Function Classification System (GMFCS) levels I-III. Presence of mild to moderate lower-limb spasticity, defined as a Modified Tardieu Scale (MTS) score between 1 and 3 in at least one major lower-limb muscle group, such as the gastrocnemius, hamstrings, or hip adductors. Able to understand and follow verbal instructions. Parent or guardian provides informed consent and the child provides assent
Exclusion Criteria:
- History of seizures or epilepsy. Implanted metal or electronic devices, such as a pacemaker. Severe cognitive impairment that prevents comprehension of study tasks. Skin allergies, lesions, or other conditions affecting the electrode application sites. Current use of antispasticity medication that could directly influence spasticity outcomes. Botulinum toxin injection within the previous 3 months. Recent orthopedic surgery or change in medication regimen within the previous 5 days. Concurrent participation in alternative or adjunct therapies outside the study protocol. Refusal to participate or withdrawal of consent/assent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Active tDCS + Virtual Reality
participants will receive active transcranial direct current stimulation at 1 mA for 20 minutes combined with virtual reality rehabilitation, three sessions per week for six weeks, for a total of 18 sessions. |
Active transcranial direct current stimulation will be delivered using saline-soaked sponge electrodes at an intensity of 1 mA for 20 minutes per session. Stimulation will be administered three times per week for six weeks, for a total of 18 sessions, concurrently with virtual reality rehabilitation. The stimulation montage will target the lower-limb motor cortical region with a supraorbital reference electrode. Virtual reality rehabilitation will be delivered using an interactive motion-based rehabilitation system and will include progressively challenging activities targeting postural control, balance, movement coordination, obstacle navigation, visual attention, dual-task performance, and cognitive-motor integration. Training will be delivered three times per week for six weeks, for a total of 18 sessions. The same VR rehabilitation protocol will be provided in both the active and sham tDCS groups.
Other Names:
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Sham Comparator: Sham tDCS + Virtual Reality
Participants will receive sham transcranial direct current stimulation using the same electrode setup as the active condition, with brief initial stimulation to mimic active tDCS, combined with the same virtual reality rehabilitation protocol, three sessions per week for six weeks, for a total of 18 sessions. |
Virtual reality rehabilitation will be delivered using an interactive motion-based rehabilitation system and will include progressively challenging activities targeting postural control, balance, movement coordination, obstacle navigation, visual attention, dual-task performance, and cognitive-motor integration. Training will be delivered three times per week for six weeks, for a total of 18 sessions. The same VR rehabilitation protocol will be provided in both the active and sham tDCS groups.
Other Names:
Sham transcranial direct current stimulation will use the same electrode montage and setup as the active condition. Active current will be delivered only during the initial 30 seconds to reproduce the initial sensory experience of stimulation, after which stimulation will be discontinued while the electrodes remain in place. Sham tDCS will be combined with the same virtual reality rehabilitation protocol as the active tDCS group |
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Active Comparator: Conventional Physical Therapy
Participants will receive conventional physical therapy including lower-limb stretching, strengthening, balance training, motor-control exercises, gait-related training, and functional mobility activities, three sessions per week for six weeks. |
Conventional physical therapy will be delivered for approximately 30 minutes per session, three sessions per week for six weeks, for a total of 18 sessions. Treatment will include lower-limb stretching, supported balance and weight-shifting activities, strengthening, motor-control exercises, gait-related training, and progressive functional mobility activities. Exercise difficulty and therapist assistance will be progressed according to participant tolerance and functional ability.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Pediatric Balance Scale Total Score
Time Frame: Baseline (Week 0), after 9 treatment sessions (approximately Week 3), and after 18 treatment sessions (approximately Week 6)
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Functional balance will be assessed using the Pediatric Balance Scale (PBS), a 14-item clinical measure of balance during functional activities. Each item is scored from 0 to 4, producing a total score ranging from 0 to 56. Higher scores indicate better functional balance. The PBS total score will be assessed at baseline, mid-intervention, and post-intervention. |
Baseline (Week 0), after 9 treatment sessions (approximately Week 3), and after 18 treatment sessions (approximately Week 6)
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Functional Reach Test Performance
Time Frame: Baseline (Week 0), after 9 treatment sessions (approximately Week 3), and after 18 treatment sessions (approximately Week 6)
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Dynamic standing balance will be assessed using the Functional Reach Test (FRT). The primary FRT metric will be maximum forward reach distance measured in centimeters while maintaining a stable standing position without taking a step or losing balance. Greater reach distance indicates better dynamic balance. Completion time in seconds will also be recorded as an additional performance metric, with shorter completion time indicating better performance. |
Baseline (Week 0), after 9 treatment sessions (approximately Week 3), and after 18 treatment sessions (approximately Week 6)
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Trail Making Test Part A and Part B Performance
Time Frame: Baseline (Week 0), after 9 treatment sessions (approximately Week 3), and after 18 treatment sessions (approximately Week 6)
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Visual attention, processing speed, and cognitive flexibility will be assessed using the Trail Making Test for Children. Completion time for Part A and Part B will be recorded in seconds. Lower completion times indicate faster cognitive performance. The difference between Part B and Part A completion times (B-A) will also be calculated as an index of the additional cognitive-flexibility and set-shifting demand associated with Part B. |
Baseline (Week 0), after 9 treatment sessions (approximately Week 3), and after 18 treatment sessions (approximately Week 6)
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Child Stroop Color and Word Test Performance
Time Frame: Baseline (Week 0), after 9 treatment sessions (approximately Week 3), and after 18 treatment sessions (approximately Week 6)
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Inhibitory control and interference processing will be assessed using a child version of the Stroop Color and Word Test. Performance measures will include word-reading time, color-naming time, color-word interference time, and error score. Completion times will be recorded in seconds, with shorter times indicating faster performance. Fewer errors indicate better inhibitory control and response accuracy. |
Baseline (Week 0), after 9 treatment sessions (approximately Week 3), and after 18 treatment sessions (approximately Week 6)
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Digit Span Test Raw Scores
Time Frame: Baseline (Week 0), after 9 treatment sessions (approximately Week 3), and after 18 treatment sessions (approximately Week 6)
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Attention, short-term memory, and working memory will be assessed using the Digit Span Test. Raw scores will be recorded for Digit Span Forward, Digit Span Backward, Digit Span Sequencing, and the overall Digit Span Total Score. Higher raw scores indicate better attention and working-memory performance. |
Baseline (Week 0), after 9 treatment sessions (approximately Week 3), and after 18 treatment sessions (approximately Week 6)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Modified Tardieu Scale
Time Frame: Baseline (Week 0), after 9 treatment sessions (approximately Week 3), and after 18 treatment sessions (approximately Week 6)
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Lower-limb spasticity will be assessed using the Modified Tardieu Scale (MTS) in the clinically more-spastic index limb. The assessment will characterize velocity-dependent resistance to passive movement across relevant lower-limb muscle groups. Measurements will include the angle of muscle reaction at fast stretch (R1), passive range of motion at slow stretch (R2), and the dynamic component of spasticity calculated as R2 minus R1, expressed in degrees. Quality of muscle reaction will also be recorded where applicable. The same designated index limb will be assessed longitudinally at all study time points. |
Baseline (Week 0), after 9 treatment sessions (approximately Week 3), and after 18 treatment sessions (approximately Week 6)
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: WAQAR AHMED AWAN, PROFESSOR, RIPHAH INTERNATIONAL UNIVERSITY PAKISTAN
Publications and helpful links
General Publications
- Grecco LA, Duarte Nde A, de Mendonca ME, Pasini H, Lima VL, Franco RC, de Oliveira LV, de Carvalho Pde T, Correa JC, Collange NZ, Sampaio LM, Galli M, Fregni F, Oliveira CS. Effect of transcranial direct current stimulation combined with gait and mobility training on functionality in children with cerebral palsy: study protocol for a double-blind randomized controlled clinical trial. BMC Pediatr. 2013 Oct 11;13:168. doi: 10.1186/1471-2431-13-168.
- Lazzari RD, Politti F, Belina SF, Collange Grecco LA, Santos CA, Dumont AJL, Lopes JBP, Cimolin V, Galli M, Santos Oliveira C. Effect of Transcranial Direct Current Stimulation Combined With Virtual Reality Training on Balance in Children With Cerebral Palsy: A Randomized, Controlled, Double-Blind, Clinical Trial. J Mot Behav. 2017 May-Jun;49(3):329-336. doi: 10.1080/00222895.2016.1204266. Epub 2016 Sep 20.
- Jung S, Song S, Lee D, Lee K, Lee G. Effects of Kinect Video Game Training on Lower Extremity Motor Function, Balance, and Gait in Adolescents with Spastic Diplegia Cerebral Palsy: A Pilot Randomized Controlled Trial. Dev Neurorehabil. 2021 Apr;24(3):159-165. doi: 10.1080/17518423.2020.1819458. Epub 2020 Sep 27.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RCRAHS-ISB/REC/MS-PT/014768
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Individual participant data will not be shared publicly because the study involves a pediatric clinical population and the consent and ethical approval were not designed for unrestricted external sharing of participant-level data. Aggregate and de-identified study results will be reported in the thesis and subsequent publications.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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