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

Sponsor:	Shriners Hospitals for Children
Information provided by:	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: Regulalry ongoing therapy

Study Type:	Interventional
Study Design:	Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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 Surgery

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 ]

Secondary Outcome Measures:

Scores on questionnaires that assess participation and patient satisfaction at initial, 6 month and 1 year post intervention.

Estimated Enrollment:	100
Study Start Date:	February 2005
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

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:	5 Years to 15 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

diagnosis of UECP
aged five to 15 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: Susan Anderson 916-453-2131 sanderson@shrinenet.org
Principal Investigator: Michelle James, MD
Sub-Investigator: Anita Bagley, PhD
United States, Florida
Shriners Hosptials for Children	Recruiting
Tampa, Florida, United States, 33612
Contact: Adrienne Karol, OTRL 813-972-2250 akarol@shrinenet.org
Principal Investigator: Alfred Hess, 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: Jeanie McGee 318-222-5704 jmcgee@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
Shriners Hospital for Children	Not yet recruiting
St. Louis, Missouri, United States, 63131
Contact: Loray Dailey, OTR 314-432-3600 ldailey@shrinenet.org
Principal Investigator: Paul Manske, MD
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: Jon Davids, 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
United States, Virginia
Kluge Childrens Rehabilitation Hospital	Not yet recruiting
Charlottesville, Virginia, United States, 22903
Contact: Walter Farrell, OTR/L WF9S@hscmail.mcc.virginia.edu]
Principal Investigator: Mark Abel, MD
Canada, Quebec
Shriners Hosptial for Children	Recruiting
Montreal, Quebec, Canada
Contact: Nathalie Bilodeau, OTRL 514-842-4464 nbilodeau@shrinenet.org
Principal Investigator: Chantal Janelle, MD

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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Fehlings D, Rang M, Glazier J, Steele C. An evaluation of botulinum-A toxin injections to improve upper extremity function in children with hemiplegic cerebral palsy. J Pediatr. 2000 Sep;137(3):331-7.

El-Said NS. Selective release of the flexor origin with transfer of flexor carpi ulnaris in cerebral palsy. J Bone Joint Surg Br. 2001 Mar;83(2):259-62.

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Thometz JG, Tachdjian M. Long-term follow-up of the flexor carpi ulnaris transfer in spastic hemiplegic children. J Pediatr Orthop. 1988 Jul-Aug;8(4):407-12.

Tonkin M, Gschwind C. Surgery for cerebral palsy: Part 2. Flexion deformity of the wrist and fingers. J Hand Surg [Br]. 1992 Aug;17(4):396-400.

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Hoffer MM. The use of the pathokinesiology laboratory to select muscles for tendon transfers in the cerebral palsy hand. Clin Orthop Relat Res. 1993 Mar;(288):135-8.

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Johanson ME, James MA, Skinner SR. Forearm muscle activation during power grip and release. J Hand Surg [Am]. 1998 Sep;23(5):938-44.

Johanson ME, Skinner SR, Lamoreux LW. Phasic relationships of the intrinsic and extrinsic thumb musculature. Clin Orthop Relat Res. 1996 Jan;(322):120-30.

Johanson ME, Skinner SR, Lamoreux LW, St Helen R, Moran SA, Ashley RK. Phasic relationships of the extrinsic muscles of the normal hand. J Hand Surg [Am]. 1990 Jul;15(4):587-94.

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.

Rab G, Petuskey K, Bagley A. A method for determination of upper extremity kinematics. Gait Posture. 2002 Apr;15(2):113-9.

Mosqueda T, James MA, Petuskey K, Bagley A, Abdala E, Rab G. Kinematic assessment of the upper extremity in brachial plexus birth palsy. J Pediatr Orthop. 2004 Nov-Dec;24(6):695-9.

Albright AL, Barry MJ, Painter MJ, Shultz B. Infusion of intrathecal baclofen for generalized dystonia in cerebral palsy. J Neurosurg. 1998 Jan;88(1):73-6.

Fedrizzi E, Pagliano E, Andreucci E, Oleari G. Hand function in children with hemiplegic cerebral palsy: prospective follow-up and functional outcome in adolescence. Dev Med Child Neurol. 2003 Feb;45(2):85-91. Erratum in: Dev Med Child Neurol. 2003 Mar;45(3):206.

Law M, King G. Parent compliance with therapeutic interventions for children with cerebral palsy. Dev Med Child Neurol. 1993 Nov;35(11):983-90.

Manske PR, Langewisch KR, Strecker WB, Albrecht MM. Anterior elbow release of spastic elbow flexion deformity in children with cerebral palsy. J Pediatr Orthop. 2001 Nov-Dec;21(6):772-7.

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Responsible Party:	Shriners Hospital for Children, Northern California ( Michelle James, MD )
Study ID Numbers:	9196-200513113
Study First Received:	November 3, 2005
Last Updated:	September 5, 2008
ClinicalTrials.gov Identifier:	NCT00250081 History of Changes
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:

Anti-Dyskinesia Agents
Brain Damage, Chronic
Nervous System Diseases
Central Nervous System Diseases
Brain Diseases
Pharmacologic Actions
Paralysis

Signs and Symptoms
Cerebral Palsy
Botulinum Toxins
Therapeutic Uses
Neurologic Manifestations
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 30, 2009