ClinicalTrials.gg
RecruitingNCT07829796Updated Sep 23, 2026

Effects of Transcranial Direct Current Stimulation Combined With Virtual Reality on Gait and Self-Esteem in Children With Spastic 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 2026-09-23.

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

Cerebral palsy can affect walking ability, muscle control, functional mobility, and psychosocial well-being in children. Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation technique that may support motor learning, while virtual reality (VR) rehabilitation provides interactive, repetitive, and task-specific motor training.

This randomized controlled trial will investigate whether active tDCS combined with VR rehabilitation provides additional benefits compared with sham tDCS combined with the same VR rehabilitation and conventional physical therapy in children with spastic cerebral palsy.

A total of 42 children aged 8 to 16 years with spastic diplegic cerebral palsy and Gross Motor Function Classification System (GMFCS) levels I-III will be randomly assigned in a 1:1:1 ratio to one of three groups: active tDCS plus VR, sham tDCS plus VR, or conventional physical therapy. Each group will receive 18 treatment sessions over six weeks, with three sessions per week.

Outcomes will be assessed before treatment, after nine sessions, and after 18 sessions. The primary outcomes will be gait performance measured using the 10-Meter Walk Test and self-esteem measured using the Rosenberg Self-Esteem Scale. Secondary outcomes will evaluate spasticity, gross motor function, functional mobility, and functional independence.

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 in children with spastic cerebral palsy. The study will compare active tDCS plus VR with sham tDCS plus an identical VR protocol and with conventional physical therapy.

Forty-two children with spastic diplegic cerebral palsy, aged 8-16 years and classified within Gross Motor Function Classification System (GMFCS) levels I-III, will be enrolled. Eligible participants will be randomly allocated in a 1:1:1 ratio, with 14 participants assigned to each treatment group. Outcome assessment will be performed by an assessor blinded to treatment allocation.

Participants in all three groups will complete 18 treatment sessions over six weeks at a frequency of three sessions per week. The active tDCS plus VR group will receive low-intensity tDCS at 1 mA for 20 minutes per session in combination with a structured VR-based rehabilitation programme. The VR programme will include progressively challenging activities directed toward postural control, balance, coordination, gait-related activity, and cognitive-motor integration.

Participants in the sham tDCS plus VR group will undergo the same electrode setup and VR rehabilitation programme. Sham stimulation will be delivered briefly at the beginning of the session to reproduce the initial sensations of stimulation without providing continued active cortical stimulation. Participants allocated to conventional physical therapy will receive a structured rehabilitation programme incorporating stretching, lower-limb strengthening, balance training, gait training, functional mobility exercises, and progressive task-specific practice.

Assessments will be conducted at baseline before the intervention (S0), after nine treatment sessions at the midpoint of the programme (S9), and following completion of 18 treatment sessions (S18).

The co-primary outcomes will be gait performance, assessed using the 10-Meter Walk Test, and self-esteem, assessed using the child version of the Rosenberg Self-Esteem Scale. Secondary outcome domains will include spasticity assessed using the Modified Tardieu Scale, gross motor function assessed using the Gross Motor Function Measure-88, functional mobility assessed using the Functional Mobility Scale, and functional independence assessed using the Pediatric Evaluation of Disability Inventory-Computer Adaptive Test (PEDI-CAT).

The study is intended to determine whether active tDCS provides an additional therapeutic effect when combined with VR rehabilitation beyond the effects associated with VR training and sham stimulation, while also comparing the technology-assisted intervention with conventional physical therapy.

03

Conditions studied

  • Spastic Diplegic Cerebral Palsy

Browse trials for

Keywords

  • Spastic Cerebral Palsy
  • Spastic Diplegia
  • Transcranial Direct Current Stimulation
  • Virtual Reality
  • VR Rehabilitation
  • Walking Speed
  • Motor Function
  • Gross Motor Function
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
    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 Comparator: Sham tDCS + Virtual Reality

    Participants will receive sham transcranial direct current stimulation using the same electrode setup, with brief initial stimulation to mimic active tDCS, combined with the same virtual reality rehabilitation protocol, three sessions per week for six weeks.

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

  • Active comparator
    Active Comparator: Conventional Physical Therapy

    Participants will receive conventional physical therapy including stretching, strengthening, balance training, gait training, and functional mobility exercises, 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.

    Also known as: Active tDCS

  • 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 early 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.

    Also known as: Sham tDCS

  • BehavioralVirtual Reality Rehabilitation

    Virtual reality rehabilitation will be delivered using a Microsoft Xbox console with Kinect motion tracking. The program will include progressive whole-body, balance, gait-related, coordination, navigation, and dual-task activities using Kinect Adventures. Training will progress through familiarization, cognitive-motor integration, and challenge/functional integration phases over six weeks. VR will be provided in both the active and sham tDCS groups for 18 sessions.

    Also known as: Xbox Kinect-Based Virtual Reality Therapy

  • BehavioralConventional Physical Therapy

    Conventional physical therapy will be delivered for 30 minutes per session, three sessions per week for six weeks, for a total of 18 sessions. Treatment will progress from lower-limb stretching, supported balance and weight shifting to strengthening, motor-control exercises, gait initiation, overground gait training, obstacle negotiation, and functional mobility activities. Exercise difficulty and therapist support will be progressed according to participant tolerance and functional ability.

    Also known as: CPT

06

What researchers measure

Primary outcomes

  1. 10-Meter Walk Test Self-Selected Walking Velocity

    Gait performance will be assessed using the 10-Meter Walk Test at a self-selected walking pace. Walking velocity will be expressed in meters per second (m/s), with higher values indicating faster walking performance. The measure will be collected 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. Child Rosenberg Self-Esteem Scale Total Score

    Global self-esteem will be assessed using the Child Rosenberg Self-Esteem Scale. The scale contains 10 items and produces a total score ranging from 0 to 30, with higher scores indicating greater self-esteem. The 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)

Secondary outcomes

  1. Modified Tardieu Scale

    Spasticity will be assessed using the Modified Tardieu Scale in the clinically affected lower-limb muscle groups. The assessment will include the quality of muscle reaction and the angles of muscle reaction (R1) and passive range of motion (R2). The dynamic component of spasticity will be calculated as R2 minus R1, expressed in degrees.

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

  2. GMFM-88

    Gross motor function will be assessed using the Gross Motor Function Measure-88 (GMFM-88). The instrument evaluates five dimensions: lying and rolling, sitting, crawling and kneeling, standing, and walking/running/jumping. Dimension and total scores will be expressed as percentages, with higher scores indicating better gross motor function.

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

  3. Functional Mobility Scale - 5 m, 50 m, and 500 m

    Functional mobility will be assessed using the Functional Mobility Scale at 5-meter, 50-meter, and 500-meter distances, representing mobility in home, school, and community environments. Each distance is rated on a 1-to-6 scale according to the level of assistance or mobility device required, with higher scores indicating greater functional mobility.

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

  4. Pediatric Evaluation of Disability Inventory-Computer Adaptive Test Daily Activities Domain Scaled Score

    Functional performance in daily activities will be assessed using the Daily Activities domain of the Pediatric Evaluation of Disability Inventory-Computer Adaptive Test (PEDI-CAT). The domain is reported as a scaled score ranging from 20 to 80. Higher scores indicate greater functional ability in daily activities and therefore a better outcome.

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

  5. Pediatric Evaluation of Disability Inventory-Computer Adaptive Test Mobility Domain Scaled Score

    Functional mobility will be assessed using the Mobility domain of the Pediatric Evaluation of Disability Inventory-Computer Adaptive Test (PEDI-CAT). Scaled scores range from 20 to 80. Higher scores indicate greater mobility-related functional ability and therefore a better outcome.

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

  6. Pediatric Evaluation of Disability Inventory-Computer Adaptive Test Social/Cognitive Domain Scaled Score

    Social and cognitive functional performance will be assessed using the Social/Cognitive domain of the Pediatric Evaluation of Disability Inventory-Computer Adaptive Test (PEDI-CAT). Scaled scores range from 20 to 80. Higher scores indicate greater social/cognitive functional ability and therefore a better outcome.

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

  7. Pediatric Evaluation of Disability Inventory-Computer Adaptive Test Responsibility Domain Scaled Score

    Functional responsibility will be assessed using the Responsibility domain of the Pediatric Evaluation of Disability Inventory-Computer Adaptive Test (PEDI-CAT). Scaled scores range from 20 to 80. Higher scores indicate greater functional responsibility and independence and therefore a better outcome.

    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

  • 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 ↗
  • 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 ↗
  • 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 ↗
  • Collange Grecco LA, de Almeida Carvalho Duarte N, Mendonca ME, Galli M, Fregni F, Oliveira CS. Effects of anodal transcranial direct current stimulation combined with virtual reality for improving gait in children with spastic diparetic cerebral palsy: a pilot, randomized, controlled, double-blind, clinical trial. Clin Rehabil. 2015 Dec;29(12):1212-23. doi: 10.1177/0269215514566997. Epub 2015 Jan 20. PubMed 25604912 ↗

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 23, 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 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07829796
Collaborators
IIMC, Riphah International University, Pakistan
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 23, 2026

Study contacts

HASSAN R 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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