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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 1997 by Office of Rare Diseases (ORD).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Seattle Children's Hospital
Information provided by:
Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:
NCT00004751
First received: February 24, 2000
Last updated: June 23, 2005
Last verified: February 1997

February 24, 2000
June 23, 2005
October 1991
Not Provided
Not Provided
Not Provided
Complete list of historical versions of study NCT00004751 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Phase II Randomized Study of Selective Dorsal Rhizotomy and Physiotherapy Vs Physiotherapy Alone for Spastic Diplegia
Not Provided

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Primary Purpose: Treatment
Spastic Diplegia
  • Procedure: Surgery
  • Procedure: Physical therapy
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
Not Provided
Not Provided
Not Provided

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
Both
3 Years to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00004751
199/11667, CHS-01699211
Not Provided
Not Provided
National Institute of Neurological Disorders and Stroke (NINDS)
Seattle Children's Hospital
Study Chair: John F. McLaughlin Seattle Children's Hospital
Office of Rare Diseases (ORD)
February 1997

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP