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

This study has been terminated.
(Accrual is complete.)
Sponsor:
Information provided by (Responsible Party):
Michelle James, Shriners Hospitals for Children
ClinicalTrials.gov Identifier:
NCT00250081
First received: November 3, 2005
Last updated: December 11, 2012
Last verified: December 2012
  Purpose

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 temporarily. Regular ongoing treatment (splinting, stretching and exercises) is another option. The investigators want to find out if surgery works better than Botulinum Toxin (Botox) injections or regular ongoing treatment (therapy), and if the effects of Botulinum Toxin injections last for longer than six months.


Condition Intervention
Cerebral Palsy
Procedure: Upper Extremity Tendon transfer
Procedure: Botulinum Toxin injections in Upper Extremity
Procedure: Regularly ongoing therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Multi Center Project: Comparison of Functional Outcomes of Tendon Transfer Surgery, Botulinum Toxin Injections and Regular Ongoing Treatment in Hemiplegic Upper Extremity Cerebral Palsy

Resource links provided by NLM:


Further study details as provided by Shriners Hospitals for Children:

Primary Outcome Measures:
  • Scores on functional assessments at initial, 6 month and 1 year post intervention. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Scores on questionnaires that assess participation and patient satisfaction at initial, 6 month and 1 year post intervention. [ Time Frame: 1 Year ] [ Designated as safety issue: No ]

Enrollment: 38
Study Start Date: February 2005
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Therapy Group
Therapy only
Procedure: Regularly ongoing therapy
Active Comparator: Surgery Group
surgical intervention
Procedure: Upper Extremity Tendon transfer
Active Comparator: Botox Injections
botulinum toxin
Procedure: Botulinum Toxin injections in Upper Extremity

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 toxin injections or regular ongoing treatment at improving function and quality of life for children with UECP. Children who are candidates for tendon surgery will be prospectively randomized to one of three treatment groups: standard tendon surgery, a series of three Botulinum toxin injections over a period of 12 months, and regular ongoing treatment. Validated tests of cognition, function and quality of life with tests of stereognosis and range of motion will be administered before, during and after treatment in order to compare outcomes of the three treatment groups.
  2. To determine if serial Botulinum toxin injections have long-term beneficial effects on upper extremity function which outlast their paralytic effects.

Botulinum toxin has been shown to have beneficial effects on UE function while the muscles injected remain weakened by the toxin. Clinicians have theorized that improvements in UE function are maintained after the toxin wears off, but this has not been proven. Children randomized to the Botulinum toxin injection group will receive 3 injections. Their function will be tested before the first injection, while the paralytic results of the second injection are still in effect, and after the paralytic effects of the third injection have worn off, and the results compared in order to determine if functional improvements outlast the medicinal effects.

  Eligibility

Ages Eligible for Study:   4 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  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: NCT00250081

Locations
United States, California
Shriners Hospitals for Children Northern California
Sacramento, California, United States, 95817
United States, Delaware
Alfred I duPont Childrens Hospital
Wilmington, Delaware, United States, 19803
United States, District of Columbia
Children's National Medical Center
Washington, District of Columbia, United States, 20010-2970
United States, Florida
Shriners Hosptials for Children
Tampa, Florida, United States, 33612
United States, Illinois
Shriners Hospitals for Children Chicago
Chicago, Illinois, United States, 60707
United States, Louisiana
Shriners Hospitals for Children
Shreveport, Louisiana, United States, 71103
United States, Minnesota
Shriners Hospitals for Children, Twin Cities
Minneapolis, Minnesota, United States, 55414
United States, Missouri
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
United States, South Carolina
Shriners Hospitals for Children
Greenville, South Carolina, United States, 29605
United States, Utah
Shriners Hosptials for Children, Intermountain
Salt Lake City, Utah, United States, 84103
Sponsors and Collaborators
Shriners Hospitals for Children
Investigators
Principal Investigator: Michelle James, MD Shriners Hospitals for Children, Northern Calfiornia
Principal Investigator: Ann Van Heest, MD Shriners Hospitals for Children, Twin Cities
Principal Investigator: Anita Bagley, PhD Shriners Hospitals for Children, Northern California
  More Information

Additional Information:
Publications:

Responsible Party: Michelle James, Chief of Orthopaedics, Shriners Hospitals for Children
ClinicalTrials.gov Identifier: NCT00250081     History of Changes
Other Study ID Numbers: 83004-278826
Study First Received: November 3, 2005
Last Updated: December 11, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Shriners Hospitals for Children:
Cerebral Palsy
Tendon Transfer
Botulinum Toxin Type A
Occupational Therapy
Child

Additional relevant MeSH terms:
Paralysis
Cerebral Palsy
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Botulinum Toxins
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 02, 2014