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

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ClinicalTrials.gov Identifier: NCT00004751
Recruitment Status : Unknown
Verified February 1997 by Office of Rare Diseases (ORD).
Recruitment status was:  Active, not recruiting
First Posted : February 25, 2000
Last Update Posted : June 24, 2005
Sponsor:
Collaborator:
Seattle Children's Hospital
Information provided by:
Office of Rare Diseases (ORD)

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.


Condition or disease Intervention/treatment Phase
Spastic Diplegia Procedure: Surgery Procedure: Physical therapy Phase 2

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.


Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Primary Purpose: Treatment
Study Start Date : October 1991

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U.S. FDA Resources





Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004751


Sponsors and Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
Seattle Children's Hospital
Investigators
Study Chair: John F. McLaughlin Seattle Children's Hospital

ClinicalTrials.gov Identifier: NCT00004751     History of Changes
Other Study ID Numbers: 199/11667
CHS-01699211
First Posted: February 25, 2000    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: February 1997

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

Additional relevant MeSH terms:
Muscle Spasticity
Cerebral Palsy
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases