- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01217242
Activity and Participation in Ambulatory Cerebral Palsy (APCP)
January 4, 2012 updated by: Kristie Bjornson, Seattle Children's Hospital
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.
The investigators would like to understand how the physical activity levels and body size of a child with cerebral palsy (CP) in a clinical situations versus out in the community relates to what they want to do in day to day life (participation in life).
The investigators believe that what a child really does out in day to day life will predict life participation to a greater degree than what they do in a structured clinical situation (i.e.
therapy session with therapist).
The investigators think that increased body size with normal growth is related to less physical activity and participation in day to day life for children with cerebral palsy (CP) who can walk.
This project will use a novel accelerometer to measure walking activity during day to day life.
Study Overview
Status
Completed
Conditions
Detailed Description
We want to know how the physical activity of children with walking problems or cerebral palsy (CP) relates to what they do in their day to day lives.
We are looking for children who:
- Have walking problems that started before age 2
- Have any type of cerebral palsy (CP) or primary problem that is a developmental movement disorder
- May have hemiplegia, diplegia, walking quadriplegia, May have ataxia, spastic, mixed tone, athetoid, or dyskinetic
- Ages 2 years to less than 10 years
- Able to do some functional walking with or without help(walkers, gait trainers)
- Project requires a one time visit to Seattle Children's Hospital of about 2 hours.
- Children and/or parents will complete surveys.
- The child will be tested for their gross motor and walking skills like at a physical therapy session.
- The child will be given an ankle monitor to wear for 7-10 days.
- They will return the monitor by mail with a questionnaire about what they did the last week.
- Families will receive a print out of their child's walking activity
Study Type
Observational
Enrollment (Actual)
128
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Washington
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Seattle, Washington, United States, 98101
- Seattle Children's Research Institute
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 years to 9 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Children with cerebral palsy (CP) or developmental movement disorder before age two who are able to walk
Description
Inclusion Criteria:
- age 2 to <10 years (30 per four age groups/2 year increments)
- Gross Motor Function Classification System (GMFCS) levels I-III
- diagnosis of cerebral palsy (CP) or developmental movement disorder that occurred prior to age two.
Exclusion Criteria:
- visual impairment limiting physical activity
- lower extremity botox injections in the last 3 months
- uncontrolled seizure disorder impacting mobility skills
- orthopedic or neurosurgery in the last 6 months.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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Children with cerebral palsy (CP)
ages 2 to < 10 years who are able to walk with or without an assistive device
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Community walking activity with the STEPWATCH accelerometer
Time Frame: Assessed at one time point with a 7-10 walking sample
|
Walking activity performance within the context of daily life will be measured with a monitor called the StepWatch.
The StepWatch was specifically designed and validated for long-term assessment of ambulatory activity during day-to-day life.
It is a small,waterproof, self-contained device that is worn on the ankle.
It records the number of strides taken every minute for up to two months between downloads.
|
Assessed at one time point with a 7-10 walking sample
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Participation will be quantified by two valid measures of pediatric life participation, the Children's Assessment of Participation and Enjoyment (CAPE) and the Assessment of Life Habits (Life-H for Children).The CAPE was designed to document the child's report of participation in day to day activities, while the Life-H for children is intended to describe a group of life habits that are characteristic of children in their environment (home, school and neighborhood).
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Assessed as one time point by parental/child report of participation in the last 4 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Carol Nicholson, MD, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2009
Primary Completion (Actual)
August 1, 2011
Study Completion (Actual)
December 1, 2011
Study Registration Dates
First Submitted
October 4, 2010
First Submitted That Met QC Criteria
October 6, 2010
First Posted (Estimate)
October 8, 2010
Study Record Updates
Last Update Posted (Estimate)
January 5, 2012
Last Update Submitted That Met QC Criteria
January 4, 2012
Last Verified
January 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- K23HD060764 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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