Activity and Participation in Ambulatory Cerebral Palsy (APCP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01217242
Recruitment Status : Completed
First Posted : October 8, 2010
Last Update Posted : January 5, 2012
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Kristie Bjornson, Seattle Children's Hospital

Brief Summary:
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.

Condition or disease
Cerebral Palsy

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
Actual Enrollment : 128 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: 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.
Study Start Date : August 2009
Actual Primary Completion Date : August 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

Children with cerebral palsy (CP)
ages 2 to < 10 years who are able to walk with or without an assistive device

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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).

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 9 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children with cerebral palsy (CP) or developmental movement disorder before age two who are able to walk

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01217242

United States, Washington
Seattle Children's Research Institute
Seattle, Washington, United States, 98101
Sponsors and Collaborators
Seattle Children's Hospital
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study Director: Carol Nicholson, MD NIH NICHD

Responsible Party: Kristie Bjornson, Assistant Professor Pediatrics, Seattle Children's Hospital Identifier: NCT01217242     History of Changes
Other Study ID Numbers: K23HD060764 ( U.S. NIH Grant/Contract )
K23HD060764 ( U.S. NIH Grant/Contract )
First Posted: October 8, 2010    Key Record Dates
Last Update Posted: January 5, 2012
Last Verified: January 2012

Keywords provided by Kristie Bjornson, Seattle Children's Hospital:
cerebral palsy
walking activity
physical activity
activity performance
activity capacity

Additional relevant MeSH terms:
Cerebral Palsy
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases