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:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2025-12-25 @ 2:23 AM
NCT ID:
NCT04715334
Eligibility Criteria:
Inclusion Criteria:
* Aged 4-18
* GMFCS level I to III
* Spasticity as the dominant motor feature
* Children agree to wear the Mollii suit as per procedures and consent to the study
* Parents/carers agree to assist their child to wear the Mollii suit as per procedures
* Medical practitioner's approval
Exclusion Criteria:
* Individuals with electrical implanted stimulatory device
* Individuals with medical devices that are affected by magnets, such as programmable shunts.
* Individuals with cardiovascular diseases, infectious diseases, malignance (cancer), fever, pregnancy, rashes or skin problems.
* Individuals who have had Botulinum toxin done 6 months prior intervention or soft tissue release surgery done 6 months prior intervention.
* Individuals who have had change in oral medication for spasticity 1 month prior intervention.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
4 Years
Maximum Age:
18 Years
Study:
NCT04715334
Study Brief:
Protocol Section:
NCT04715334