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

NCT00004751 | Unknown Phase 2

• 2 other identifiers: 199/11667CHS-01699211
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Spastic Diplegia

Keywords

cerebral palsy; neurologic and psychiatric disorders; rare disease; spastic diplegia

Interventions

Surgery PROCEDURE

Physical therapy PROCEDURE

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS): lead
• Seattle Children's Hospital: collaborator

MeSH Terms

Conditions

Cerebral Palsy; Neurologic Manifestations; Mental Disorders; Rare Diseases

Interventions

Surgical Procedures, Operative; Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• John F. McLaughlin

  Seattle Children's Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: February 24, 2000
• First Posted: February 25, 2000
• Study Start: October 1, 1991
• Last Updated: June 24, 2005

Record last verified: 1997-02