Spastic Diplegic Cerebral PalsyNCT07829770
Effects of Transcranial Direct Current Stimulation Combined With Virtual Reality on Balance and Executive Functions in Children With Spastic Diplegic Cerebral Palsy
A study testing Active Transcranial Direct Current Stimulation, Virtual Reality Rehabilitation and Conventional Physical Therapy in people with Spastic Diplegic Cerebral Palsy, run by Riphah International University at 2 sites in Pakistan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 8 to 16 years
- Conditions the study is for
- Spastic Diplegic Cerebral Palsy
- What is being tested?
- Active Transcranial Direct Current Stimulation, Virtual Reality Rehabilitation and Conventional Physical Therapy
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 2 sitesPakistan
- Study dates
- 15 Sep 2026to 28 Oct 2026
- Phase
- Interventional
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 8 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan2 sites, 2 recruiting
- Recruiting
Al-Farabi Special Education Centre for Physically Handicapped
Islamabad, 44000
hassan rauf, MS PEDIATRIC PHYSICAL THERAPY, hassanrauf507@gmail.com
- Recruiting
Sedum School of Rehabilitation
Islamabad, 44000
hassan rauf, MS PEDIATRIC PHYSICAL THERAPY, +923161504297, hassanrauf507@gmail.com
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Spastic Diplegic Cerebral Palsy
- Being tested
- Active Transcranial Direct Current Stimulation, Sham Transcranial Direct Current Stimulation, Virtual Reality Rehabilitation, Conventional Physical Therapy
- Keywords
- Spastic Diplegic Cerebral Palsy, Transcranial Direct Current Stimulation, Virtual Reality, Executive Function, Cognitive Flexibility
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Transcranial Direct Current StimulationDevice
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.
Sham Transcranial Direct Current StimulationDevice
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
Virtual Reality RehabilitationBehavioural
Also called VR Rehabilitation, Xbox Kinect-Based Virtual Reality Therapy
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.
Conventional Physical TherapyBehavioural
Also called CPT
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.
| Study group | Role | What they receive |
|---|---|---|
| Active tDCS + Virtual Reality | Experimental | 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. Receives: Device: Active Transcranial Direct Current Stimulation; Behavioral: Virtual Reality Rehabilitation |
| Sham tDCS + Virtual Reality | Sham comparator | 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. Receives: Device: Sham Transcranial Direct Current Stimulation; Behavioral: Virtual Reality Rehabilitation |
| Conventional Physical Therapy | Active comparator | 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. Receives: Behavioral: Conventional Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pediatric Balance Scale Total Score
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.
Measured: Baseline (Week 0), after 9 treatment sessions (approximately Week 3), and after 18 treatment sessions (approximately Week 6)
Functional Reach Test Performance
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.
Measured: Baseline (Week 0), after 9 treatment sessions (approximately Week 3), and after 18 treatment sessions (approximately Week 6)
Trail Making Test Part A and Part B Performance
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.
Measured: Baseline (Week 0), after 9 treatment sessions (approximately Week 3), and after 18 treatment sessions (approximately Week 6)
Child Stroop Color and Word Test Performance
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.
Measured: Baseline (Week 0), after 9 treatment sessions (approximately Week 3), and after 18 treatment sessions (approximately Week 6)
Digit Span Test Raw Scores
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.
Measured: Baseline (Week 0), after 9 treatment sessions (approximately Week 3), and after 18 treatment sessions (approximately Week 6)
Secondary outcomes (1)
Modified Tardieu Scale
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.
Measured: Baseline (Week 0), after 9 treatment sessions (approximately Week 3), and after 18 treatment sessions (approximately Week 6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2026
- Study start15 Sep 2026
- Primary completion28 Oct 2026 (estimated)
- Study completion28 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Spastic Diplegic Cerebral PalsyStudies 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 1:1:1 ratio to one of three parallel intervention groups: active transcranial direct current stimulation combined with virtual reality rehabilitation, sham transcranial direct current stimulation combined with the same virtual reality rehabilitation, or conventional physical therapy. Each group will receive 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Waqar Ahmed Awan, Riphah International University
- Investigators
- WAQAR AHMED AWAN, PROFESSOR, Study chair, RIPHAH INTERNATIONAL UNIVERSITY PAKISTAN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07829770
- Sponsor's protocol ID
- RCRAHS-ISB/REC/MS-PT/014768
- Status last verified
- Sep 2026
- First submitted
- 15 Sep 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 27644454Grecco 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.
PubMed 24112817Jung 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.
PubMed 32981401