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:
2025-12-24 @ 6:48 PM
Ignite Modification Date:
2025-12-24 @ 6:48 PM
NCT ID:
NCT01961557
Eligibility Criteria:
* INCLUSION CRITERIA:
* Age 5 years and above
* Either a healthy volunteer, have crouch gait with a diagnosis of spastic diplegic cerebral palsy, or have lower extremity weakness resulting in gait pathology from a diagnosis of muscular dystrophy, spina bifida, or incomplete spinal cord injury.
* Able to understand and follow simple directions based on parent report and physician observation during history and physical examination.
* Able to provide verbal/written assent.
* Less than 5 degrees of knee flexion contracture with hip extended in supine position. Hamstring contracture as assessed by straight leg raising test does not limit ability to participate in the study.
* Less than 10 degrees of plantar flexion contracture in neutral foot alignment.
* A measured foot-thigh angle of -10 to 25 degrees in prone position.
* Diagnosed with knee extension deficiency as indicated by a crouched posture during gait lacking at least 20 degrees of knee extension at mid stance during walking as assessed visually, knee extensor muscle weakness which prevents full extension of the limb, or reliance upon braces or other aids which lock the knee during walking. (The exact level of knee extension deficiency, or crouch, will be quantified after inclusion using gait analysis.)
* Able to walk at least 10 feet without stopping with or without a walking aid
* Agreement to not drink caffeine for 24 hours before each EEG assessment (CP only) visit because it can modify brain activity
EXCLUSION CRITERIA:
* Any neurological, musculoskeletal or cardiorespiratory injury, health condition, or diagnosis other than cerebral palsy, muscular dystrophy, spina bifida, or incomplete spinal cord injury that would affect the ability to walk as directed for short periods of time.
* Participation in this protocol within the previous 1 year.
ADDITIONAL EXCLUSION CRITERIA FOR INDIVIDUALS WITH CEREBRAL PALSY:
* A history of a seizure in the past year.
* Pregnancy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
5 Years
Maximum Age:
100 Years
Study:
NCT01961557
Study Brief:
Protocol Section:
NCT01961557