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 @ 11:44 PM
Ignite Modification Date:
2025-12-24 @ 11:44 PM
NCT ID:
NCT00004751
Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
* Spastic diplegia, i.e.: Measurable spasticity with more lower than upper limb involvement
* Fair to good trunk and head control
* Little or no bulbar involvement
* Able to walk or has potential to walk indoors with assistive devices
* No fixed musculoskeletal deformity greater than 15 degrees
* Prior orthopedic surgery acceptable if spastic muscle group is in physiologic biomechanical position and retains voluntary power
* No detectable athetosis, rigidity, ataxia, or other movement disorder
* No disease-related, treatable condition that may become urgent during study, e.g., hip subluxation requiring adductor release
--Patient Characteristics--
* Age: 3 to 18
* Other: Intelligence Quotient greater than 50 Developmental age 3 years or higher
* Able to follow multi-step commands
* Expressive communication skills at 3-year level or higher
* Mild dysarthria or drooling does not exclude
* Stable social environment
* Regular school and physical therapy attendance
* Normal psychiatric status
* Guardian able to give support and follow-up care
* No medical contraindication to anesthesia or surgery, e.g.: Previous anesthesia reaction
* Chronic lung disease
* Uncontrollable seizures
* Scoliosis Vertebral anomaly
* Neural tube defect
* No visual impairment sufficient to hinder mobility
* Able to come to Children's Hospital and Medical Center for follow-up Insurance coverage adequate for surgery and postoperative physiotherapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Years
Maximum Age:
18 Years
Study:
NCT00004751
Study Brief:
Protocol Section:
NCT00004751