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
  Purpose

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
Cerebral Palsy

Study Type: Observational
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Seattle Children's Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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).


Enrollment: 128
Study Start Date: August 2009
Study Completion Date: December 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Children with cerebral palsy (CP)
ages 2 to < 10 years who are able to walk with or without an assistive device

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
  Eligibility

Ages Eligible for Study:   2 Years to 9 Years
Genders Eligible for Study:   Both
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

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01217242

Locations
United States, Washington
Seattle Children's Research Institute
Seattle, Washington, United States, 98101
Sponsors and Collaborators
Seattle Children's Hospital
Investigators
Study Director: Carol Nicholson, MD NIH NICHD
  More Information

No publications provided

Responsible Party: Kristie Bjornson, Assistant Professor Pediatrics, Seattle Children's Hospital
ClinicalTrials.gov Identifier: NCT01217242     History of Changes
Other Study ID Numbers: K23HD060764, K23HD060764
Study First Received: October 4, 2010
Last Updated: January 4, 2012
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Cerebral Palsy
Paralysis
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on July 20, 2014