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 @ 2:17 AM
Ignite Modification Date:
2025-12-25 @ 2:17 AM
NCT ID:
NCT05020834
Eligibility Criteria:
Inclusion Criteria:
* Their weight should be less than 40 kg.
* The spasticity degrees of the affected lower limb will range between grades (1, 1+ \& 2) according to Modified Ashworth Scale (MAS).
* Those children functioning scores at Gross Motor Function Classification System (GMFCS) Levels I and II.
* They can walk 10 min conditionally without an orthosis.
* Ought to be intellectually skilled and ready to comprehend and take after directions.
* They will have neither serious nor recurring medical complications.
* Children's height will be more than 100 cm to fit with the Biodex balance equipment that will be used in this study to evaluate balance performance.
* No serious hip \& knee flexion tightness will be present. Knee flexion at starting contact should be between 20-40ยบ .
* Peroneal nerve and the proximal leg muscles ought to be in place.
* They ought to have no significant issues influencing balance other than spasticity.
Exclusion Criteria:
* Children who demonstrate skin diseases or allergic reactions to adhesive tape or any other materials used in this study.
* Children with visual, auditory or perceptual deficits.
* Children with surgical interference for the lower limb.
* Children with seizures or epilepsy.
* Children who received botulinum toxin in the lower extremity musculature during the past 6 months or who wish to receive it within the period of study, other spasticity medication within 3 months of pre-treatment testing .
* Children with pacemakers or other diseases that are contraindicated by electrical stimulation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
8 Years
Maximum Age:
10 Years
Study:
NCT05020834
Study Brief:
Protocol Section:
NCT05020834