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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 December 2012 |
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Main ID: |
NCT00250081 |
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Date of registration:
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03/11/2005 |
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Primary sponsor: |
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Public title:
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Comparison of Tendon Transfer, Botox Injections and Ongoing Treatment in Hemiplegic Cerebral Palsy
UECP |
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Scientific title:
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Multi Center Project: Comparison of Functional Outcomes of Tendon Transfer Surgery, Botulinum Toxin Injections and Regular Ongoing Treatment in Hemiplegic Upper Extremity Cerebral Palsy |
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Date of first enrolment:
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February 2005 |
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Target sample size:
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38 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT00250081 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label
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Countries of recruitment
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Canada
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United States
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Contacts
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Name:
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Michelle James, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Shriners Hospitals for Children, Northern Calfiornia |
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Name:
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Anita Bagley, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Shriners Hospitals for Children, Northern California |
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Name:
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Ann Van Heest, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Shriners Hospitals for Children, Twin Cities |
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Key inclusion & exclusion criteria
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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
Age minimum:
4 Years
Age maximum:
17 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Cerebral Palsy
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Intervention(s)
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Procedure: Botulinum Toxin injections in Upper Extremity
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Procedure: Regularly ongoing therapy
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Procedure: Upper Extremity Tendon transfer
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Primary Outcome(s)
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Scores on functional assessments at initial, 6 month and 1 year post intervention.
[Time Frame: 1 year]
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Secondary Outcome(s)
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Scores on questionnaires that assess participation and patient satisfaction at initial, 6 month and 1 year post intervention.
[Time Frame: 1 Year]
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Secondary ID(s)
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83004-278826
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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