Down Syndrome
Conditions
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.
Detailed description
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.
Interventions
DIAGNOSTIC_TESTConventional Physical Therapy
Participants in the control group will receive standard, evidence-based physical therapy targeting gross motor skills, including exercises for strength, balance and functional mobility
COMBINATION_PRODUCTExperimental group (tDCS + Virtual Reality)
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
Sponsors
Superior University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Timed Up and Go (TUG) Test | 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. |
| Raven's Colored Progressive Matrices (RCPM) | 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. |
| Pediatric Balance Scale (PBS) | 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 |
| Caregiver Strain Index (CSI) | 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. |
Countries
Pakistan
Outcome results
None listed