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 @ 4:25 AM
Ignite Modification Date:
2025-12-25 @ 4:25 AM
NCT ID:
NCT00503620
Eligibility Criteria:
Inclusion Criteria:
1. A diagnosis of spastic hemiplegic or diplegic CP
2. Children must be ambulatory without the use of assistive devices
3. Children must be between the ages of 4 and 12 years
4. Children must be cleared by an orthopedic surgeon for risk of hip subluxation or dislocation and cannot have significant scoliosis (curvature \> 40 degrees)
5. Children must be seizure-free or seizure controlled
6. Children must have visuoperceptual skills and cognitive/communication skills sufficient to follow multiple step commands and to attend to tasks associated with data collection
7. Children's passive range of motion in lower extremity joints must be less than 20 degrees of flexion contracture at the hips as measured by the Thomas Test, at least 20 degrees of hip abduction bilaterally, les than 0 degrees of knee flexion contracture, popliteal angle less than 55 degrees, and at least 0 degrees of ankle dorsiflexion with the knee extended while the foot is in varus
8. Children who are planning to undergo botulinum toxin injections of the gastrocnemius and/or soleus muscles without serial casting as clinically dictated for the treatment of muscle spasticity
Exclusion Criteria:
1. Children who have a diagnosis of "mixed" types of CP (i.e. athetosis) or other movement disorders (i.e. ataxia)
2. Children who have had a selective dorsal rhizotomy, are presently are receiving intrathecal Baclofen, or have changed their spasticity medications in the past 6 months.
3. Children who have a metallic or electrical implants
4. Children who are unable to stay in the MRI machine for the 8 to 10 minute duration of the exam.
5. Children who have a history of claustrophobia.
6. Female children cannot be pregnant. A pregnancy test will be given if it is possible that the child can become pregnant, to ascertain whether or not the child is pregnant.
7. Children who are planning to receive serial casting post botox injection.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
4 Years
Maximum Age:
12 Years
Study:
NCT00503620
Study Brief:
Protocol Section:
NCT00503620