Effects of (tDCS) Combined With Virtual Reality Versus CPT on Brain, Cognitive, and GMS in Childr… (NCT07385066) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Effects of (tDCS) Combined With Virtual Reality Versus CPT on Brain, Cognitive, and GMS in Children With DS.
Pakistan30 participantsStarted 2025-04-17
Plain-language 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.
Who can participate
Age range
6 Years – 12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.