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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
  Purpose

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 Intervention Phase
Spastic Diplegia
Procedure: Surgery
Procedure: Physical therapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Office of Rare Diseases (ORD):

Study Start Date: October 1991
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.

  Eligibility

Ages Eligible for Study:   3 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004751

Sponsors and Collaborators
Seattle Children's Hospital
Investigators
Study Chair: John F. McLaughlin Seattle Children's Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00004751     History of Changes
Other Study ID Numbers: 199/11667, CHS-01699211
Study First Received: February 24, 2000
Last Updated: June 23, 2005
Health Authority: United States: Federal Government

Keywords provided by Office of Rare Diseases (ORD):
cerebral palsy
neurologic and psychiatric disorders
rare disease
spastic diplegia

Additional relevant MeSH terms:
Cerebral Palsy
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on November 20, 2014