Effects of (tDCS) Combined With Virtual Reality Versus CPT on Brain, Cognitive, and GMS in Children With DS.

NCT07385066 | Active Not Recruiting DMC

• 1 other identifier: PhDRSW/Batch-Fall23/2229
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled trial aims to compare the effects of transcranial direct current stimulation (tDCS) combined with virtual reality-based training versus conventional physical therapy on brain activity, cognitive function, and gross motor skills in children with Down syndrome. Children with Down syndrome commonly exhibit motor and cognitive impairments associated with altered neurodevelopment, which may benefit from neuroplasticity-oriented interventions.

Conditions

Down Syndrome

Outcome Measures

Primary Outcomes (4)

• Timed Up and Go (TUG) Test

  Assesses functional mobility and walking ability. Time in seconds is recorded for the participant to stand from a chair, walk 3 meters, turn, return, and sit down. Shorter times indicate better mobility.

  24 Months

• Raven's Colored Progressive Matrices (RCPM)

  Assesses non-verbal reasoning and general cognitive ability. Scoring is based on the number of correct answers, with higher scores indicating better cognitive function.

  24 Months

• Pediatric Balance Scale (PBS)

  Assesses balance and postural control. Comprises 14 items scored from 0 to 4. Total score ranges from 0-56, with higher scores indicating better balance

  24 Months

• Caregiver Strain Index (CSI)

  Measures caregiver burden and well-being. Contains 13 items scored 0 (No) or 1 (Yes). Total score ranges 0-13; higher scores indicate greater strain.

  18 Months

Study Arms (2)

Experimental group (tDCS + Virtual Reality)

EXPERIMENTAL

Combination Product: Experimental group (tDCS + Virtual Reality)

Conventional Physical Therapy

ACTIVE COMPARATOR

Diagnostic Test: Conventional Physical Therapy

Interventions

Conventional Physical Therapy DIAGNOSTIC_TEST

Participants in the control group will receive standard, evidence-based physical therapy targeting gross motor skills, including exercises for strength, balance and functional mobility

Conventional Physical Therapy

Experimental group (tDCS + Virtual Reality) COMBINATION_PRODUCT

Participants will receive non-invasive tDCS in combination with interactive, task-oriented VR exercises designed to improve gross motor skills such as balance, standing, walking, and functional mobility. Each session will be supervised by licensed physiotherapists

Experimental group (tDCS + Virtual Reality)

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 6-12 years diagnosed with Down syndrome by a pediatrician.
• Compromised gross motor performance in standing, walking, running, or jumping domains of the Gross Motor Function Measure (GMFM).
• Stable medical and neurological status.
• Parental/guardian informed consent and cooperation.
• Documented balance difficulties.
• Ability to follow simple instructions in Urdu or locally spoken language.
• Regular accessibility to the intervention site.

You may not qualify if:

• Neurological conditions other than Down syndrome.
• Red flag conditions such as tumors, fractures, metabolic diseases, or dislocations.
• Visual, cardiopulmonary, or severe musculoskeletal impairments requiring surgical management.
• Recent surgery in the past 12 months.
• Seizure history or sensitivity to electrical stimulation.
• Presence of metal implants or hearing aids.
• Tactile or sensory processing issues that prevent participation in therapy.

Sponsors & Collaborators

• Superior University: lead

Study Sites (1)

Superior University CRC

Lahore, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Down Syndrome

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 14, 2026
• First Posted: February 3, 2026
• Study Start: April 17, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): April 30, 2027
• Last Updated: February 3, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)