Down SyndromeNCT07385066
Effects of (tDCS) Combined With Virtual Reality Versus CPT on Brain, Cognitive, and GMS in Children With DS.
A study testing Conventional Physical Therapy and Experimental group (tDCS + Virtual Reality) in people with Down Syndrome, run by Superior University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Down Syndrome
- What is being tested?
- Conventional Physical Therapy and Experimental group (tDCS + Virtual Reality)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 17 Apr 2025to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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.
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.
Read the 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.
- Conditions
- Down Syndrome
- Being tested
- Conventional Physical Therapy, Experimental group (tDCS + Virtual Reality)
- Medical subject headings
- Down Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional Physical TherapyDiagnostic 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
| Study group | Role | What they receive |
|---|---|---|
| Experimental group (tDCS + Virtual Reality) | Experimental | Not described Receives: Combination Product: Experimental group (tDCS + Virtual Reality) |
| Conventional Physical Therapy | Active comparator | Not described Receives: Diagnostic Test: Conventional Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Timed Up and Go (TUG) Test
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.
Measured: 24 Months
Raven's Colored Progressive Matrices (RCPM)
Assesses non-verbal reasoning and general cognitive ability. Scoring is based on the number of correct answers, with higher scores indicating better cognitive function.
Measured: 24 Months
Pediatric Balance Scale (PBS)
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
Measured: 24 Months
Caregiver Strain Index (CSI)
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.
Measured: 18 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2026
- Study start17 Apr 2025
- Primary completion1 Apr 2026 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Down SyndromeStudies of the same condition, open and under way.
- More trials run by Superior UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Superior University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Naveed Babur, Superior University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07385066
- Sponsor's protocol ID
- PhDRSW/Batch-Fall23/2229
- Status last verified
- Jan 2026
- First submitted
- 14 Jan 2026
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT07385066
- Acronym / sponsor ID
- PhDRSW/Batch-Fall23/2229
- Conditions
- Down Syndrome
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 17 Apr 2025 (actual)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 3 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group (tDCS + Virtual Reality) | Experimental | Combination Product: Experimental group (tDCS + Virtual Reality) |
| Conventional Physical Therapy | Active comparator | Diagnostic Test: Conventional Physical Therapy |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional Physical TherapyParticipants in the control group will receive standard, evidence-based physical therapy targeting gross motor skills, including exercises for strength, balance and functional mobility | Diagnostic test | Conventional Physical Therapy |
| Experimental 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 | Combination product | Experimental group (tDCS + Virtual Reality) |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Physical Therapy and Experimental group (tDCS + Virtual Reality) in people with Down Syndrome, run by Superior University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Timed Up and Go (TUG) Test (time frame: 24 Months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2026.