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Status:

COMPLETED

Long-term Outcomes of Selective Dorsal Rhizotomy Among Individuals With Cerebral Palsy

Lead Sponsor:

Gillette Children's Specialty Healthcare

Collaborating Sponsors:

Shriners Hospitals for Children

Conditions:

Cerebral Palsy

Eligibility:

All Genders

21-45 years

Brief Summary

Spasticity affects up to 80% of individuals diagnosed with cerebral palsy. Selective dorsal rhizotomy (SDR) is a surgical method used by some hospitals to permanently reduce spasticity in order to pre...

Detailed Description

Spasticity affects up to 80% of individuals diagnosed with cerebral palsy. Excessive spasticity is thought to be uncomfortable, reduce function, cause gait deviations (e.g. equinus), and contribute to...

Eligibility Criteria

Inclusion

  • Inclusion Criteria for Controls (-SDR) and Cases (+SDR):
  • Able to speak and read English
  • Diagnosed with bilateral cerebral palsy (i.e. no hemiplegics)
  • Minimum age of 21 years presently
  • Had a baseline gait and motion analysis
  • Controls (-SDR):
  • No SDR
  • No history of intrathecal baclofen (ITB) pump implantation for \> 1 year
  • No ITB pump at time of long-term follow-up (explant \> or = 6 months)
  • No history of oral baclofen for \> 1 year
  • No oral baclofen use at time of long-term follow-up
  • No more than 10 sessions on botulinum toxin, phenol, or alcohol injection
  • Cases (+SDR):
  • History of SDR \> 5 years ago
  • Had a baseline gait analysis \< or = 18 months before SDR
  • Exclusion Criteria:
  • none

Exclusion

    Key Trial Info

    Start Date :

    November 1 2018

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ACTUAL

    End Date :

    January 31 2020

    Estimated Enrollment :

    78 Patients enrolled

    Trial Details

    Trial ID

    NCT03789786

    Start Date

    November 1 2018

    End Date

    January 31 2020

    Last Update

    October 13 2023

    Active Locations (3)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 1 (3 locations)

    1

    Gillette Children's Specialty Healthcare

    Saint Paul, Minnesota, United States, 55101

    2

    Shriners Hospitals for Children - Salt Lake City

    Salt Lake City, Utah, United States, 84103

    3

    Shriners Hospitals for Childrens - Spokane

    Spokane, Washington, United States, 99204