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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 October 2012 |
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Main ID: |
NCT01217242 |
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Date of registration:
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04/10/2010 |
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Primary sponsor: |
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Public title:
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Activity and Participation in Ambulatory Cerebral Palsy
APCP |
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Scientific title:
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Cross-sectional Descriptive Study to Quantify to What Extent Activity Capacity, Performance and Body Composition Predict Day to Day Life Participation in Ambulatory Children With CP. |
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Date of first enrolment:
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August 2009 |
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Target sample size:
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128 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01217242 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort, Time Perspective: Cross-Sectional
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Countries of recruitment
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United States
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Contacts
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Name:
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Carol Nicholson, 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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NIH NICHD |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. age 2 to <10 years (30 per four age groups/2 year increments)
2. Gross Motor Function Classification System (GMFCS) levels I-III
3. diagnosis of cerebral palsy (CP) or developmental movement disorder that occurred
prior to age two.
Exclusion Criteria:
1. visual impairment limiting physical activity
2. lower extremity botox injections in the last 3 months
3. uncontrolled seizure disorder impacting mobility skills
4. orthopedic or neurosurgery in the last 6 months.
Age minimum:
2 Years
Age maximum:
9 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Cerebral Palsy
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Primary Outcome(s)
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Community walking activity with the STEPWATCH accelerometer
[Time Frame: Assessed at one time point with a 7-10 walking sample]
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Secondary Outcome(s)
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Participation in day to day life activities
[Time Frame: Assessed as one time point by parental/child report of participation in the last 4 months]
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Secondary ID(s)
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K23HD060764
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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