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 @ 9:40 PM
Ignite Modification Date:
2025-12-24 @ 9:40 PM
NCT ID:
NCT00419432
Eligibility Criteria:
Inclusion Criteria:
1. Diagnosis of spastic cerebral palsy.
2. Age 6 to 15 years at the time of the initial assessment.
3. Gross Motor Function Classification System (GMFCS) levels II or III (demonstrable independent ambulatory potential with or without orthotics/assist devices).
4. Patients have been referred for assessment and treatment of gait abnormality.
5. Patients have a gait abnormality interfering with their physical function.
6. Patients are candidates for orthopaedic surgery including soft tissue and/or bony procedures involving at least 2 levels, in one or both lower extremities (e.g. knee \& ankle).
7. Patients must be able to undergo instrumented gait analysis in a motion laboratory.
Exclusion Criteria:
1. Presence of dystonia, athetosis, or mixed tone abnormalities.
2. History of orthopaedic lower extremity procedures within the previous 2 years.
3. Patients who have had previous gait laboratory analysis that has been seen by the treating surgeon.
4. Patients who will be unable to return for the required follow up visits/gait analysis.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
15 Years
Study:
NCT00419432
Study Brief:
Protocol Section:
NCT00419432