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

    • Washington
      • Seattle, Washington, United States, 98101
        • Seattle Children's Research Institute

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:

  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.

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

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).
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.

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

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.

Clinical Trials on Cerebral Palsy

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