Activity and Participation in Ambulatory Cerebral Palsy (APCP)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Kristie Bjornson, Seattle Children's Hospital
ClinicalTrials.gov Identifier:
NCT01217242
First received: October 4, 2010
Last updated: January 4, 2012
Last verified: January 2012

October 4, 2010
January 4, 2012
August 2009
August 2011   (final data collection date for primary outcome measure)
Community walking activity with the STEPWATCH accelerometer [ Time Frame: Assessed at one time point with a 7-10 walking sample ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01217242 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
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).
Same as current
Not Provided
Not Provided
 
Activity and Participation in Ambulatory Cerebral Palsy
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.

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
Observational
Observational Model: Cohort
Time Perspective: Cross-Sectional
Not Provided
Not Provided
Non-Probability Sample

Children with cerebral palsy (CP) or developmental movement disorder before age two who are able to walk

Cerebral Palsy
Not Provided
Children with cerebral palsy (CP)
ages 2 to < 10 years who are able to walk with or without an assistive device
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
128
December 2011
August 2011   (final data collection date for primary outcome measure)

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.
Both
2 Years to 9 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01217242
K23HD060764, K23HD060764
No
Kristie Bjornson, Seattle Children's Hospital
Seattle Children's Hospital
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study Director: Carol Nicholson, MD NIH NICHD
Seattle Children's Hospital
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP