Comparison of Tendon Transfer, Botox Injections and Ongoing Treatment in Hemiplegic Cerebral Palsy
NCT ID: NCT00250081
Last Updated: 2014-11-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
38 participants
INTERVENTIONAL
2005-02-28
2013-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
NONE
Study Groups
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Therapy Group
Therapy only
Regularly ongoing therapy
Surgery Group
surgical intervention
Upper Extremity Tendon transfer
Botox Injections
botulinum toxin
Botulinum Toxin injections in Upper Extremity
Interventions
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Upper Extremity Tendon transfer
Botulinum Toxin injections in Upper Extremity
Regularly ongoing therapy
Eligibility Criteria
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Inclusion Criteria
* aged four to 17 years
* candidate for standard surgical management (tendon transfer)
Exclusion Criteria
* 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
4 Years
17 Years
ALL
No
Sponsors
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Shriners Hospitals for Children
OTHER
Responsible Party
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Michelle James
Chief of Orthopaedics
Principal Investigators
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Michelle James, MD
Role: PRINCIPAL_INVESTIGATOR
Shriners Hospitals for Children, Northern Calfiornia
Ann Van Heest, MD
Role: PRINCIPAL_INVESTIGATOR
Shriners Hospitals for Children, Twin Cities
Anita Bagley, PhD
Role: PRINCIPAL_INVESTIGATOR
Shriners Hospitals for Children, Northern California
Locations
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Shriners Hospitals for Children Northern California
Sacramento, California, United States
Alfred I duPont Childrens Hospital
Wilmington, Delaware, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
Shriners Hosptials for Children
Tampa, Florida, United States
Shriners Hospitals for Children Chicago
Chicago, Illinois, United States
Shriners Hospitals for Children
Shreveport, Louisiana, United States
Shriners Hospitals for Children, Twin Cities
Minneapolis, Minnesota, United States
Children's Mercy Hospital
Kansas City, Missouri, United States
Shriners Hospitals for Children
Greenville, South Carolina, United States
Shriners Hosptials for Children, Intermountain
Salt Lake City, Utah, United States
Countries
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References
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BAX MC. TERMINOLOGY AND CLASSIFICATION OF CEREBRAL PALSY. Dev Med Child Neurol. 1964 Jun;6:295-7. doi: 10.1111/j.1469-8749.1964.tb10791.x. No abstract available.
Autti-Ramo I, Larsen A, Taimo A, von Wendt L. Management of the upper limb with botulinum toxin type A in children with spastic type cerebral palsy and acquired brain injury: clinical implications. Eur J Neurol. 2001 Nov;8 Suppl 5:136-44. doi: 10.1046/j.1468-1331.2001.00046.x.
Autti-Ramo I, Larsen A, Peltonen J, Taimo A, von Wendt L. Botulinum toxin injection as an adjunct when planning hand surgery in children with spastic hemiplegia. Neuropediatrics. 2000 Feb;31(1):4-8. doi: 10.1055/s-2000-15289.
Wall SA, Chait LA, Temlett JA, Perkins B, Hillen G, Becker P. Botulinum A chemodenervation: a new modality in cerebral palsied hands. Br J Plast Surg. 1993 Dec;46(8):703-6. doi: 10.1016/0007-1226(93)90203-n.
Wallen MA, O'flaherty SJ, Waugh MC. Functional outcomes of intramuscular botulinum toxin type A in the upper limbs of children with cerebral palsy: a phase II trial. Arch Phys Med Rehabil. 2004 Feb;85(2):192-200. doi: 10.1016/j.apmr.2003.05.008.
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. doi: 10.1067/mpd.2000.108393.
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. doi: 10.1302/0301-620x.83b2.10763.
Hoffer MM, Lehman M, Mitani M. Long-term follow-up on tendon transfers to the extensors of the wrist and fingers in patients with cerebral palsy. J Hand Surg Am. 1986 Nov;11(6):836-40. doi: 10.1016/s0363-5023(86)80232-5.
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. doi: 10.1097/01241398-198807000-00005.
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. doi: 10.1016/s0266-7681(05)80261-x.
Wenner SM, Johnson KA. Transfer of the flexor carpi ulnaris to the radial wrist extensors in cerebral palsy. J Hand Surg Am. 1988 Mar;13(2):231-3. doi: 10.1016/s0363-5023(88)80055-8.
Wolf TM, Clinkscales CM, Hamlin C. Flexor carpi ulnaris tendon transfers in cerebral palsy. J Hand Surg Br. 1998 Jun;23(3):340-3. doi: 10.1016/s0266-7681(98)80054-5.
Beach WR, Strecker WB, Coe J, Manske PR, Schoenecker PL, Dailey L. Use of the Green transfer in treatment of patients with spastic cerebral palsy: 17-year experience. J Pediatr Orthop. 1991 Nov-Dec;11(6):731-6. doi: 10.1097/01241398-199111000-00006.
Strecker WB, Emanuel JP, Dailey L, Manske PR. Comparison of pronator tenotomy and pronator rerouting in children with spastic cerebral palsy. J Hand Surg Am. 1988 Jul;13(4):540-3. doi: 10.1016/s0363-5023(88)80091-1.
Manske PR. Redirection of extensor pollicis longus in the treatment of spastic thumb-in-palm deformity. J Hand Surg Am. 1985 Jul;10(4):553-60. doi: 10.1016/s0363-5023(85)80082-4.
Hoffer MM, Perry J, Melkonian G. Postoperative electromyographic function of tendon transfers in patients with cerebral palsy. Dev Med Child Neurol. 1990 Sep;32(9):789-91. doi: 10.1111/j.1469-8749.1990.tb08482.x.
Perry J, Hoffer MM. Preoperative and postoperative dynamic electromyography as an aid in planning tendon transfers in children with cerebral palsy. J Bone Joint Surg Am. 1977 Jun;59(4):531-7.
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.
Kozin SH, Keenan MA. Using dynamic electromyography to guide surgical treatment of the spastic upper extremity in the brain-injured patient. Clin Orthop Relat Res. 1993 Mar;(288):109-17.
Mowery CA, Gelberman RH, Rhoades CE. Upper extremity tendon transfers in cerebral palsy: electromyographic and functional analysis. J Pediatr Orthop. 1985 Jan-Feb;5(1):69-72. doi: 10.1097/01241398-198501000-00012.
Johanson ME, James MA, Skinner SR. Forearm muscle activation during power grip and release. J Hand Surg Am. 1998 Sep;23(5):938-44. doi: 10.1016/S0363-5023(98)80177-9.
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. doi: 10.1016/s0363-5023(09)90020-x.
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. doi: 10.1097/01.BCR.0000054170.62555.09.
Rab G, Petuskey K, Bagley A. A method for determination of upper extremity kinematics. Gait Posture. 2002 Apr;15(2):113-9. doi: 10.1016/s0966-6362(01)00155-2.
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. doi: 10.1097/00004694-200411000-00018.
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. doi: 10.3171/jns.1998.88.1.0073.
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.
Law M, King G. Parent compliance with therapeutic interventions for children with cerebral palsy. Dev Med Child Neurol. 1993 Nov;35(11):983-90. doi: 10.1111/j.1469-8749.1993.tb11580.x.
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.
Rodriquez AA, McGinn M, Chappell R. Botulinum toxin injection of spastic finger flexors in hemiplegic patients. Am J Phys Med Rehabil. 2000 Jan-Feb;79(1):44-7. doi: 10.1097/00002060-200001000-00010.
Tonkin MA, Hatrick NC, Eckersley JR, Couzens G. Surgery for cerebral palsy part 3: classification and operative procedures for thumb deformity. J Hand Surg Br. 2001 Oct;26(5):465-70. doi: 10.1054/jhsb.2001.0601.
Van Heest AE, House JH, Cariello C. Upper extremity surgical treatment of cerebral palsy. J Hand Surg Am. 1999 Mar;24(2):323-30. doi: 10.1053/jhsu.1999.0323.
Bourke-Taylor H. Melbourne Assessment of Unilateral Upper Limb Function: construct validity and correlation with the Pediatric Evaluation of Disability Inventory. Dev Med Child Neurol. 2003 Feb;45(2):92-6.
Related Links
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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
Other Identifiers
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83004-278826
Identifier Type: -
Identifier Source: org_study_id