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.

Condition	Treatment or Intervention	Phase
Spastic Diplegia	Procedure: Surgery  Procedure: Physical therapy	Phase II

Further Study Details: 

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.

Ages Eligible for Study:  3 Years   -   18 Years,  Genders Eligible for Study:  Both

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Spastic diplegia, i.e.: Measurable spasticity with more lower than upper limb involvement
• Fair to good trunk and head control
• Little or no bulbar involvement
• Able to walk or has potential to walk indoors with assistive devices
• No fixed musculoskeletal deformity greater than 15 degrees
• Prior orthopedic surgery acceptable if spastic muscle group is in physiologic biomechanical position and retains voluntary power
• No detectable athetosis, rigidity, ataxia, or other movement disorder
• No disease-related, treatable condition that may become urgent during study, e.g., hip subluxation requiring adductor release

--Patient Characteristics--

• Age: 3 to 18
• Other: Intelligence Quotient greater than 50 Developmental age 3 years or higher
• Able to follow multi-step commands
• Expressive communication skills at 3-year level or higher
• Mild dysarthria or drooling does not exclude
• Stable social environment
• Regular school and physical therapy attendance
• Normal psychiatric status
• Guardian able to give support and follow-up care
• No medical contraindication to anesthesia or surgery, e.g.: Previous anesthesia reaction
• Chronic lung disease
• Uncontrollable seizures
• Scoliosis Vertebral anomaly
• Neural tube defect
• No visual impairment sufficient to hinder mobility
• Able to come to Children's Hospital and Medical Center for follow-up Insurance coverage adequate for surgery and postoperative physiotherapy

Study chairs or principal investigators

John F. McLaughlin,  Study Chair,  Children's Hospital and Medical Center - Seattle   

Study ID Numbers:  199/11667; CHS-01699211
Record last reviewed:  February 1997
Last Updated:  October 13, 2004
Record first received:  February 24, 2000
ClinicalTrials.gov Identifier:  NCT00004751
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08