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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.
The specific aims of this study and the methodology for achieving them are:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Therapy Group | Active Comparator | Therapy only |
|
| Surgery Group | Active Comparator | surgical intervention |
|
| Botox Injections | Active Comparator | botulinum toxin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Upper Extremity Tendon transfer | Procedure |
| ||
| Botulinum Toxin injections in Upper Extremity |
| Measure | Description | Time Frame |
|---|---|---|
| Shriners Hospitals Upper Extremity Evaluation (SHUEE) | Initial, 6 mon, 1 year | |
| Box & Blocks | Initial, 6 mon, 1 year | |
| Assisting Hand Assessment (AHA) | Initial, 6 mon, 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Scores on questionnaires that assess participation and patient satisfaction at initial, 6 month and 1 year post intervention. | Initial, 6 mon, 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shriners Hospitals for Children Northern California | Sacramento | California | 95817 | United States | ||
| Alfred I duPont Childrens Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14155190 | Background | 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. | |
| 11851742 | Background | 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. |
| Label | URL |
|---|---|
| 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 | View source |
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| Procedure |
|
| Regularly ongoing therapy | Procedure |
|
| Wilmington |
| Delaware |
| 19803 |
| United States |
| Children's National Medical Center | Washington D.C. | District of Columbia | 20010-2970 | United States |
| Shriners Hosptials for Children | Tampa | Florida | 33612 | United States |
| Shriners Hospitals for Children Chicago | Chicago | Illinois | 60707 | United States |
| Shriners Hospitals for Children | Shreveport | Louisiana | 71103 | United States |
| Shriners Hospitals for Children, Twin Cities | Minneapolis | Minnesota | 55414 | United States |
| Children's Mercy Hospital | Kansas City | Missouri | 64108 | United States |
| Shriners Hospitals for Children | Greenville | South Carolina | 29605 | United States |
| Shriners Hosptials for Children, Intermountain | Salt Lake City | Utah | 84103 | United States |
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| 8298785 | Background | 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. |
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| 11284577 | Background | 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. |
| 3794239 | Background | 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. |
| 3392191 | Background | 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. |
| 1402265 | Background | 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. |
| 3351249 | Background | 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. |
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| 1960196 | Background | 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. |
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| 4020069 | Background | 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. |
| 2227142 | Background | 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. |
| 863949 | Background | 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. |
| 8458126 | Background | 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. |
| 8458122 | Background | 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. |
| 3980710 | Background | 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. |
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| 8542687 | Background | Johanson ME, Skinner SR, Lamoreux LW. Phasic relationships of the intrinsic and extrinsic thumb musculature. Clin Orthop Relat Res. 1996 Jan;(322):120-30. |
| 2380522 | Background | 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. |
| 12626930 | Background | 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. |
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| 10678602 | Background | 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. |
| 11560430 | Background | 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. |
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| 12578234 | Background | 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. |
| ID | Term |
|---|---|
| D002547 | Cerebral Palsy |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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