NCT00250081

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

10 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2005

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

November 3, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 7, 2005

Completed
7.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

November 19, 2014

Status Verified

November 1, 2014

Enrollment Period

8.2 years

First QC Date

November 3, 2005

Last Update Submit

November 18, 2014

Conditions

Cerebral Palsy

Keywords

Cerebral PalsyTendon TransferBotulinum Toxin Type AOccupational TherapyChild

Outcome Measures

Primary Outcomes (3)

  • 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

Secondary Outcomes (1)

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

    Initial, 6 mon, 1 year

Study Arms (3)

Therapy Group

ACTIVE COMPARATOR

Therapy only

Procedure: Regularly ongoing therapy

Surgery Group

ACTIVE COMPARATOR

surgical intervention

Procedure: Upper Extremity Tendon transfer

Botox Injections

ACTIVE COMPARATOR

botulinum toxin

Procedure: Botulinum Toxin injections in Upper Extremity

Interventions

Upper Extremity Tendon transferPROCEDURE
Surgery Group
Botulinum Toxin injections in Upper ExtremityPROCEDURE
Botox Injections
Regularly ongoing therapyPROCEDURE
Therapy Group

Eligibility Criteria

Age4 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Shriners Hospitals for Children Northern California

Sacramento, California, 95817, United States

Location

Alfred I duPont Childrens Hospital

Wilmington, Delaware, 19803, United States

Location

Children's National Medical Center

Washington D.C., District of Columbia, 20010-2970, United States

Location

Shriners Hosptials for Children

Tampa, Florida, 33612, United States

Location

Shriners Hospitals for Children Chicago

Chicago, Illinois, 60707, United States

Location

Shriners Hospitals for Children

Shreveport, Louisiana, 71103, United States

Location

Shriners Hospitals for Children, Twin Cities

Minneapolis, Minnesota, 55414, United States

Location

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

Shriners Hospitals for Children

Greenville, South Carolina, 29605, United States

Location

Shriners Hosptials for Children, Intermountain

Salt Lake City, Utah, 84103, United States

Location

Related Publications (34)

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    PMID: 14155190BACKGROUND

  • 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.

    PMID: 11851742BACKGROUND

  • 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.

    PMID: 10774988BACKGROUND

  • 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.

    PMID: 8298785BACKGROUND

  • 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.

    PMID: 14966702BACKGROUND

  • 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.

    PMID: 10969256BACKGROUND

  • 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.

    PMID: 11284577BACKGROUND

  • 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.

    PMID: 3794239BACKGROUND

  • 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.

    PMID: 3392191BACKGROUND

  • 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.

    PMID: 1402265BACKGROUND

  • 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.

    PMID: 3351249BACKGROUND

  • 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.

    PMID: 9665522BACKGROUND

  • 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.

    PMID: 1960196BACKGROUND

  • 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.

    PMID: 3418056BACKGROUND

  • 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.

    PMID: 4020069BACKGROUND

  • 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.

    PMID: 2227142BACKGROUND

  • 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.

    PMID: 863949BACKGROUND

  • 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.

    PMID: 8458126BACKGROUND

  • 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.

    PMID: 8458122BACKGROUND

  • 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.

    PMID: 3980710BACKGROUND

  • 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.

    PMID: 9763276BACKGROUND

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

    PMID: 8542687BACKGROUND

  • 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.

    PMID: 2380522BACKGROUND

  • 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.

    PMID: 12626930BACKGROUND

  • 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.

    PMID: 11869904BACKGROUND

  • 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.

    PMID: 15502572BACKGROUND

  • 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.

    PMID: 9420075BACKGROUND

  • 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.

    PMID: 12578233BACKGROUND

  • 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.

    PMID: 8224565BACKGROUND

  • 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.

    PMID: 11675553BACKGROUND

  • 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.

    PMID: 10678602BACKGROUND

  • 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.

    PMID: 11560430BACKGROUND

  • 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.

    PMID: 10194018BACKGROUND

  • 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.

    PMID: 12578234BACKGROUND

Related Links

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • 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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of Orthopaedics

Study Record Dates

First Submitted

November 3, 2005

First Posted

November 7, 2005

Study Start

February 1, 2005

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

November 19, 2014

Record last verified: 2014-11

Locations

US(10)