Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-26 @ 3:15 PM
NCT ID:
NCT07385066
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
12 Years
Study:
NCT07385066
Study Brief:
Protocol Section:
NCT07385066