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.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Timed Up and Go (TUG) Test
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Experimental group (tDCS + Virtual Reality)
干预措施: Experimental group (tDCS + Virtual Reality) (Combination Product)
Conventional Physical Therapy
干预措施: Conventional Physical Therapy (Diagnostic Test)
结局指标
主要结局
Timed Up and Go (TUG) Test
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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.
次要结局
未报告次要终点
研究者
Muhammad Naveed Babur
Principal Investigator
Superior University