Status:

TERMINATED

Comparison of Tendon Transfer, Botox Injections and Ongoing Treatment in Hemiplegic Cerebral Palsy

Lead Sponsor:

Shriners Hospitals for Children

Conditions:

Cerebral Palsy

Eligibility:

All Genders

4-17 years

Phase:

NA

Brief Summary

Doctors use different treatments for people with Cerebral Palsy. Surgery is one option. Botulinum toxin injections are another option; these are given directly into spastic muscles to weaken them temp...

Detailed Description

The specific aims of this study and the methodology for achieving them are: 1. To determine if tendon surgery for the forearm, wrist and thumb deformities of UECP is more effective than Botulinum tox...

Eligibility Criteria

Inclusion

  • diagnosis of UECP
  • aged four to 17 years
  • candidate for standard surgical management (tendon transfer)

Exclusion

  • subject could benefit from procedures in addition to standard surgical management and releases, and these procedures could be performed at the same anesthetic (for example, elbow flexor release)
  • previous Botulinum toxin injection session in the affected UE in \< 1 year
  • previous ipsilateral UE surgery
  • primary language other than English or Spanish
  • subject and/or parent unwilling to attend eight therapy sessions and perform home exercise protocol

Key Trial Info

Start Date :

February 1 2005

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

May 1 2013

Estimated Enrollment :

38 Patients enrolled

Trial Details

Trial ID

NCT00250081

Start Date

February 1 2005

End Date

May 1 2013

Last Update

November 19 2014

Active Locations (10)

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Page 1 of 3 (10 locations)

1

Shriners Hospitals for Children Northern California

Sacramento, California, United States, 95817

2

Alfred I duPont Childrens Hospital

Wilmington, Delaware, United States, 19803

3

Children's National Medical Center

Washington D.C., District of Columbia, United States, 20010-2970

4

Shriners Hosptials for Children

Tampa, Florida, United States, 33612