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Completed

NCT Number: NCT01217242

Activity and Participation in Ambulatory Cerebral Palsy

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.

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Key information

Age range

2 year–9 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Seattle Children's Research Institute

Seattle, Washington, 98101, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Seattle Children's Hospital

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Official study 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.

Acronym: APCP

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Oct 8, 2010
Registry last updated
Jan 5, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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