Effects of Transcranial Direct Current Stimulation Combined With Virtual Reality on Gait and Self-Esteem in Children With Spastic Cerebral Palsy

NCT07829796 | Recruiting

• 1 other identifier: RCRAHS-ISB/REC/MS-PT/02334
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Spastic Diplegic Cerebral Palsy

Keywords

Spastic Cerebral Palsy; Spastic Diplegia; Transcranial Direct Current Stimulation; Virtual Reality; VR Rehabilitation; Walking Speed; Motor Function; Gross Motor Function

Outcome Measures

Primary Outcomes (2)

• 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.

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

• 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.

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

Secondary Outcomes (7)

• Modified Tardieu Scale

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

• GMFM-88

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

• Functional Mobility Scale - 5 m, 50 m, and 500 m

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

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

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

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

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

Study Arms (3)

Experimental: 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.

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

Sham Comparator: Sham tDCS + Virtual Reality

SHAM COMPARATOR

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: Conventional Physical Therapy

ACTIVE COMPARATOR

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

Active Transcranial Direct Current Stimulation DEVICE

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

Experimental: Active tDCS + Virtual Reality

Sham Transcranial Direct Current Stimulation DEVICE

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

Sham Comparator: Sham tDCS + Virtual Reality

Virtual Reality Rehabilitation BEHAVIORAL

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

Experimental: Active tDCS + Virtual Reality; Sham Comparator: Sham tDCS + Virtual Reality

Conventional Physical Therapy BEHAVIORAL

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

Active Comparator: Conventional Physical Therapy

Eligibility Criteria

• Age: 8 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Riphah International University: lead
• IIMC, Riphah International University, Pakistan: collaborator

Study Sites (2)

Al-Farabi Special Education Centre for Physically Handicapped

Islamabad, 44000, Pakistan

RECRUITING

Sedum School of Rehabilitation

Islamabad, 44000, Pakistan

RECRUITING

Related Publications (4)

• 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.

  PMID: 32981401 BACKGROUND

• 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.

  PMID: 24112817 BACKGROUND

• 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.

  PMID: 27644454 BACKGROUND

• 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.

  PMID: 25604912 BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy

Interventions

2-cyclohexylidenhydrazo-4-phenyl-thiazole

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• WAQAR AHMED AWAN, PROFESSOR

  RIPHAH INTERNATIONAL UNIVERSITY PAKISTAN

  STUDY CHAIR

Central Study Contacts

HASSAN R RAUF, MS PEDIATRIC PHYSICAL THERAPY

CONTACT

+923161504297; hassanrauf507@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessments will be performed by an assessor who is blinded to participant group allocation. Participants assigned to the active and sham tDCS groups will undergo the same electrode placement and virtual reality rehabilitation protocol. The sham condition will mimic the initial sensation of active stimulation; however, because the conventional physical therapy arm involves a visibly different intervention, participant masking will not apply across all three study groups
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head OF Department

Model Details: 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 sessions, and after 18 sessions.

Study Record Dates

• First Submitted: September 15, 2026
• First Posted: September 21, 2026
• Study Start: September 15, 2026
• Primary Completion (Estimated): October 28, 2026
• Study Completion (Estimated): October 28, 2026
• Last Updated: September 23, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

PA (2)