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NCT Number: NCT07385066

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

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

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Superior University CRC

Lahore, Punjab Province, Pakistan

About this study

Eligible participants will be randomly allocated into two groups. The experimental group will receive tDCS in combination with virtual reality-based training, while the control group will receive only conventional physical therapy. Interventions will be administered by licensed physiotherapists over a defined treatment period. Gross motor outcomes will be assessed using standardized measures such as the Gross Motor Function Measure (GMFM). Cognitive function will be evaluated using age-appropriate cognitive assessments, and brain activity will be assessed using electroencephalography (EEG), where applicable. Assessments will be conducted at baseline and after completion of the intervention period. The study will adhere to ethical principles, including informed consent from parents or guardians, participant confidentiality, and the right to withdraw at any stage.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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

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

Primary outcomes

  1. Timed Up and Go (TUG) Test

    Time frame: 24 Months

    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.

  2. Raven's Colored Progressive Matrices (RCPM)

    Time frame: 24 Months

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

  3. Pediatric Balance Scale (PBS)

    Time frame: 24 Months

    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

  4. Caregiver Strain Index (CSI)

    Time frame: 18 Months

    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.

Sponsors and collaborators

Lead sponsor

Superior University

Other

Registry information

Official study title

Effects of Transcranial Direct Current Stimulation (tDCS) Combined With Virtual Reality Versus Conventional Physical Therapy on Brain Activity, Cognitive Function, and Gross Motor Skills in Children With Down Syndrome.

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Feb 3, 2026
Registry last updated
Feb 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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