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

Primary Purpose

Spastic Diplegia

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Surgery
Physical therapy
Sponsored by
National Institute of Neurological Disorders and Stroke (NINDS)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spastic Diplegia focused on measuring cerebral palsy, neurologic and psychiatric disorders, rare disease, spastic diplegia

Eligibility Criteria

3 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    February 24, 2000
    Last Updated
    June 23, 2005
    Sponsor
    National Institute of Neurological Disorders and Stroke (NINDS)
    Collaborators
    Seattle Children's Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00004751
    Brief Title
    Phase II Randomized Study of Selective Dorsal Rhizotomy and Physiotherapy Vs Physiotherapy Alone for Spastic Diplegia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 1997
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 1991 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    National Institute of Neurological Disorders and Stroke (NINDS)
    Collaborators
    Seattle Children's Hospital

    4. Oversight

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Spastic Diplegia
    Keywords
    cerebral palsy, neurologic and psychiatric disorders, rare disease, spastic diplegia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Allocation
    Randomized

    8. Arms, Groups, and Interventions

    Intervention Type
    Procedure
    Intervention Name(s)
    Surgery
    Intervention Type
    Procedure
    Intervention Name(s)
    Physical therapy

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    3 Years
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    John F. McLaughlin
    Organizational Affiliation
    Seattle Children's Hospital
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

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

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