Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2025-12-24 @ 11:44 PM
NCT ID:
NCT00004751
Brief Summary:
OBJECTIVES:
I. Assess the efficacy and safety of selective dorsal rhizotomy and physiotherapy compared with physiotherapy alone in improving gross motor function and reducing spasticity in children with spastic diplegia.
Detailed Description:
PROTOCOL OUTLINE: This is a randomized study. Patients are stratified by age and the ability to ambulate 50 feet unaided. Each stratum is block randomized.
Patients are randomly assigned to surgery plus intensive physical therapy versus intensive physical therapy alone.
The surgical procedure is a selective dorsal rhizotomy. Physical therapy (PT) includes passive and active range of motion, facilitation of isolated muscle control, transitional movements, strengthening, transfer skills, and gait training. The PT schedule is 2-hour sessions 5 days a week for 1 month, 1-hour sessions 5 days a week for 5 months, then a standard therapy program for the remainder of the study (total of 6 months). Parents supervise exercise on non-PT days.
Patients are followed at 6, 12, and 24 months.
Study:
NCT00004751
Study Brief:
Protocol Section:
NCT00004751