ClinicalTrials.gg
RecruitingNCT07829770Updated Sep 21, 2026

Effects of Transcranial Direct Current Stimulation Combined With Virtual Reality on Balance and Executive Functions in Children With Spastic Diplegic Cerebral Palsy

An interventional study of Active Transcranial Direct Current Stimulation and Sham Transcranial Direct Current Stimulation in Spastic Diplegic Cerebral Palsy, sponsored by Riphah International University. Recruiting at 2 sites in Pakistan. Open to participants aged 8 Years to 16 Years. Per ClinicalTrials.gov, last updated 2026-09-21.

Sponsored by Riphah International University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Sep 2026; still recruiting 1 month later.
Phase
Not applicable
Study type
Interventional
Enrollment
42
Allocation
Randomized
Ages
8 Years to 16 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 134 studies in Cerebral Palsy by Riphah International University — 37 open to participants now, 37 under way, none of them phase 3. Cerebral Palsy · Riphah International University.

Planned enrollment
31st of 124
42 · median 30
Started
2026
with 16 others
No phase
124 of 134
34 open now
Primary completion
2026-10
later than 26 of 36 live
Registered
126th of 134
by date

Among the 134 studies in Cerebral Palsy by Riphah International University, this one is the 31st largest by planned enrollment of the 124 interventional ones that give a count, is one of 17 that started in 2026, is one of 124 with no phase, reaches primary completion later than 26 of the 36 other live ones, and was the 126th registered.

Cerebral Palsy

1,936 studies on the registry are indexed under Cerebral Palsy; 458 are open to participants now.

Browse Cerebral Palsy studies →

Open to participants now

37 of the 134 studies in Cerebral Palsy by Riphah International University are open now, in 1 country. Recruiting first, the newest first:

31 more — sign in →

By country, each count listing its studies:

All 37 open studies →

Where they have run

Who these studies take

Of the 270 Cerebral Palsy studies recruiting now, 27 (10%) set no upper age limit and 235 (87%) stop at 75 or younger; 255 take children under 18; 51 take healthy volunteers.

This study: 8 Years to 16 Years · all sexes · no healthy volunteers.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 134 studies in Cerebral Palsy by Riphah International University, or all of them as a file.
02

Study 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. 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.

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.

03

Conditions studied

  • Spastic Diplegic Cerebral Palsy

Browse trials for

Keywords

  • Spastic Diplegic Cerebral Palsy
  • Transcranial Direct Current Stimulation
  • Virtual Reality
  • Executive Function
  • Cognitive Flexibility
04

Who can participate

Ages eligible
8 Years to 16 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 and the child provides assent

Exclusion criteria

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
42 participants (estimated)

Study arms

  • 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.

    Device: Active Transcranial Direct Current Stimulation · Behavioral: Virtual Reality Rehabilitation

  • 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.

    Device: Sham Transcranial Direct Current Stimulation · Behavioral: Virtual Reality Rehabilitation

  • 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.

    Behavioral: Conventional Physical Therapy

Interventions

  • DeviceActive Transcranial Direct Current Stimulation

    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.

  • DeviceSham Transcranial Direct Current Stimulation

    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

  • BehavioralVirtual Reality Rehabilitation

    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.

    Also known as: VR Rehabilitation, Xbox Kinect-Based Virtual Reality Therapy

  • BehavioralConventional Physical Therapy

    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.

    Also known as: CPT

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline (Week 0), after 9 treatment sessions (approximately Week 3), and after 18 treatment sessions (approximately Week 6)

  2. 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.

    Time frame: Baseline (Week 0), after 9 treatment sessions (approximately Week 3), and after 18 treatment sessions (approximately Week 6)

  3. 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.

    Time frame: Baseline (Week 0), after 9 treatment sessions (approximately Week 3), and after 18 treatment sessions (approximately Week 6)

  4. 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.

    Time frame: Baseline (Week 0), after 9 treatment sessions (approximately Week 3), and after 18 treatment sessions (approximately Week 6)

  5. 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.

    Time frame: 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.

    Time frame: Baseline (Week 0), after 9 treatment sessions (approximately Week 3), and after 18 treatment sessions (approximately Week 6)

07

Study locations

2 of 2 sites recruiting
08

References and documents

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 27644454 ↗
  • 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. PubMed 24112817 ↗
  • 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. PubMed 32981401 ↗

Individual participant data

Plan to share: 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.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2026 (actual). Primary completion is estimated for Oct 2026, 1 month after the start.

Of 902 non-industry interventional studies with no phase under Cerebral Palsy, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 31. This study's planned 1 month is below that.

Counting every sponsor, half of 921 studies reached it within 12 months; a quarter within 5 and three quarters within 31.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 15, 2026
First posted
Sep 21, 2026
StartActual
Sep 15, 2026
Primary completionEst.
Oct 28, 2026
CompletionEst.
Oct 28, 2026
Last update
Sep 21, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07829770
Responsible party
Waqar Ahmed Awan (Head OF Department, Riphah International University) — Principal investigator
First posted
Sep 21, 2026
Start date
Sep 15, 2026
Primary completion
Oct 28, 2026 (estimated)
Completion
Oct 28, 2026 (estimated)
Last update
Sep 21, 2026

Study contacts

hassan rauf, MS PEDIATRIC PHYSICAL THERAPY
Contact
hassanrauf507@gmail.com
+923161504297
WAQAR AHMED AWAN, PROFESSOR
study chair · RIPHAH INTERNATIONAL UNIVERSITY PAKISTAN

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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