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 @ 5:04 AM
Ignite Modification Date:
2025-12-25 @ 5:04 AM
NCT ID:
NCT04271618
Eligibility Criteria:
Inclusion Criteria:
* Have a definite diagnosis of spastic diplegia obtained from medical files or personal physicians and supported by magnetic resonance images (MRIs).
* Their weight should be less than 40 kg.
* The degree of spasticity in the affected lower extremity will ranged between grades (1, 1+\&2) according to Modified Ashworth Scale.
* The levels of gross motor function will be selected at level II according to Gross Motor Function Classification System.
* The children will be included have the ability to stand alone for five minutes.
* Children should be able to understand and follow instructions.
* The degree of the spinal kyphosis ,for all participated children , in sagittal plane should be not more than 55° as Kyphosis above 55° is considered as fixed hyper-kyphosis while
Exclusion Criteria:
* Children with GMFCS levels III, IV, and V or use any assistive mobility devices
* Children suffering from allergic problems in their skin.
* Children with visual, auditory or cognitive deficits.
* Fixed and significant deformities of the lower limb and spine.
* Children with surgical interference for the lower limb and spine within the previous 2 years.
* Children with seizures.
* Children with fixed hyper-kyphosis (kyphotic angle is more than 55°).
* Children who used any medications (e.g., steroids) that affect growth or body composition.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
8 Years
Maximum Age:
10 Years
Study:
NCT04271618
Study Brief:
Protocol Section:
NCT04271618