Phase II Randomized Study of Selective Dorsal Rhizotomy and Physiotherapy Vs Physiotherapy Alone for Spastic Diplegia
|ClinicalTrials.gov Identifier: NCT00004751|
Recruitment Status : Unknown
Verified February 1997 by Office of Rare Diseases (ORD).
Recruitment status was: Active, not recruiting
First Posted : February 25, 2000
Last Update Posted : June 24, 2005
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.
|Condition or disease||Intervention/treatment||Phase|
|Spastic Diplegia||Procedure: Surgery Procedure: Physical therapy||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Study Start Date :||October 1991|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004751
|Study Chair:||John F. McLaughlin||Seattle Children's Hospital|