NCT00004751

Phase II Randomized Study of Selective Dorsal Rhizotomy and Physiotherapy Vs Physiotherapy Alone for Spastic Diplegia

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: National Institute of Neurological Disorders and Stroke (NINDS) · NIH
• Sex: All
• Age: 3 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Spastic Diplegia

Interventions

Type	Name	Description
PROCEDURE	Surgery
PROCEDURE	Physical therapy

Timeline

• Start date: 1991-10-01
• First posted: 2000-02-25
• Last updated: 2005-06-24