Comparison of Tendon Transfer, Botox Injections and Ongoing Treatment in Hemiplegic Cerebral Palsy - Full Text View

Sponsor:	Shriners Hospitals for Children
Information provided by (Responsible Party):	Michelle James, Shriners Hospitals for Children
ClinicalTrials.gov Identifier:	NCT00250081

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:

MedlinePlus related topics: Botox Cerebral Palsy Paralysis

Drug Information available for: Clostridium botulinum toxin

U.S. FDA Resources

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 ]

Estimated Enrollment:	78
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
No Intervention: Therapy Group	Procedure: Regularly ongoing therapy
Active Comparator: Surgery Group	Procedure: Upper Extremity Tendon transfer
Active Comparator: Botox Injections	Procedure: Botulinum Toxin injections in Upper Extremity

Detailed Description:

The specific aims of this study and the methodology for achieving them are:

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.
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00250081

Contacts

Contact: Michelle James, MD	916-453-2049	mjames@shrinenet.org
Contact: Anita Bagley, PhD	916-453-2280	abagley@shrinenet.org

Locations

United States, California
Shriners Hospitals for Children, Northern California	Recruiting
Sacramento, California, United States, 95817
Contact: Sherry Middleton 916-453-2354 smiddleton@shrinenet.org
Principal Investigator: Michelle James, MD
Sub-Investigator: Anita Bagley, PhD
United States, Delaware
Alfred I duPont Childrens Hospital	Recruiting
Wilmington, Delaware, United States, 19803
Contact: Chris Church 302-651-4614 cchurch@nemours.org
Principal Investigator: Jennifer Ty, MD
United States, District of Columbia
Children's National Medical Center	Not yet recruiting
Washington, District of Columbia, United States, 20010-2970
Contact: Cathy Fox, OTR/L 202-476-4964 cafox@cnmc.org
Principal Investigator: Emily Hattwick, M.D.
United States, Florida
Shriners Hosptials for Children	Recruiting
Tampa, Florida, United States, 33612
Contact: Lynn White, OTRL 813-972-2250 lwhite@shrinenet.org
Principal Investigator: Alfred Hess, MD
United States, Illinois
Shriners Hospitals for Children Chicago	Recruiting
Chicago, Illinois, United States, 60707
Contact: Jasmine Gilliam 773-385-5875 jgilliam@shrinenet.org
Principal Investigator: Randipsingh Bindra, MD
United States, Louisiana
Shriners Hospitals for Children	Recruiting
Shreveport, Louisiana, United States, 71103
Contact: Anne Boyd, LOTR 318-222-5704 aboyd@shrinenet.org
Contact: Susan Campbell 318-222-5704 scampbell@shrinenet.org
Principal Investigator: Phillip Gates, MD
United States, Minnesota
Shriners Hospitals for Children, Twin Cities	Recruiting
Minneapolis, Minnesota, United States, 55414
Contact: Wendy Tomhave, OTR 612-596-6100 wtomhave@shrinenet.org
Principal Investigator: Ann Van Heest, MD
United States, Missouri
Children's Mercy Hospital	Not yet recruiting
Kansas City, Missouri, United States, 64108
Contact: Carolien de Roode, M.D. 816-234-3693 caroliende@cmh.edu
Contact: Andrea Melanson, OTR/L 816-234-3380 almelanson@cmh.edu
Principal Investigator: Carolien de Roode, M.D.
United States, South Carolina
Shriners Hospitals for Children	Recruiting
Greenville, South Carolina, United States, 29605
Contact: Lisa Wagner, OTR 864-271-3444 lwagner@shrinenet.org
Contact: Laura Peace, OTR 864-271-3444 lpeace@shrinenet.org
Principal Investigator: David Westberry, MD
United States, Utah
Shriners Hosptials for Children, Intermountain	Recruiting
Salt Lake City, Utah, United States, 84103
Contact: Barbara Johnson, PT 801-536-3500 bjohnson@shrinenet.org
Contact: Bruce McWilliams, PhD 801-536-3500
Principal Investigator: Douglas Hutchinson, MD
Canada, Quebec
Shriners Hosptial for Children	Withdrawn
Montreal, Quebec, Canada

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:

Official website for Shriners Hospitals for Children, a network of 22 hospitals that provide expert, no-cost orthopaedic and burn care to children under 18 This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

Publications:

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Palmieri TL, Petuskey K, Bagley A, Takashiba S, Greenhalgh DG, Rab GT. Alterations in functional movement after axillary burn scar contracture: a motion analysis study. J Burn Care Rehabil. 2003 Mar-Apr;24(2):104-8.

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Responsible Party:	Michelle James, Chief of Orthopaedics, Shriners Hospitals for Children
ClinicalTrials.gov Identifier:	NCT00250081 History of Changes
Other Study ID Numbers:	9196-200513113
Study First Received:	November 3, 2005
Last Updated:	January 24, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by Shriners Hospitals for Children:

Cerebral Palsy
Tendon Transfer
Botulinium Toxin Type A
Occupational Therapy
Child

Additional relevant MeSH terms:

Cerebral Palsy
Paralysis
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations

Signs and Symptoms
Botulinum Toxins
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012