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.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Superior University
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Timed Up and Go (TUG) Test
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 6 Years to 12 Years (Child)
- Sex
- All
- Accepts 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.
Arms & Interventions
Experimental group (tDCS + Virtual Reality)
Intervention: Experimental group (tDCS + Virtual Reality) (Combination Product)
Conventional Physical Therapy
Intervention: Conventional Physical Therapy (Diagnostic Test)
Outcomes
Primary Outcomes
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.
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.
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
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Muhammad Naveed Babur
Principal Investigator
Superior University