Clinical trial NCT01217242: Activity and Participation in Ambulatory Cerebral Palsy
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Palsy
Keywords: cerebral palsy
walking activity
physical activity
participation
activity performance
activity capacity
Lead sponsor: Seattle Children's Hospital
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2010-10-08
Enrollment: 128
Sex: ALL
Minimum age (years): 2
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children with cerebral palsy (CP) or developmental movement disorder before age two who are able to walk

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.

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 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.

Primary outcomes:
measure: Community walking activity with the STEPWATCH accelerometer
timeFrame: Assessed at one time point with a 7-10 walking sample
Secondary outcomes:
measure: Participation in day to day life activities
timeFrame: Assessed as one time point by parental/child report of participation in the last 4 months
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Seattle Children's Research Institute
state: Washington
Study officials:
affiliation: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: Carol Nicholson, MD
role: STUDY_DIRECTOR
References: