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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01217242
Other study ID # K23HD060764
Secondary ID K23HD060764
Status Completed
Phase N/A
First received October 4, 2010
Last updated January 4, 2012
Start date August 2009
Est. completion date December 2011

Study information

Verified date January 2012
Source Seattle Children's Hospital
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 128
Est. completion date December 2011
Est. primary completion date August 2011
Accepts healthy volunteers No
Gender Both
Age group 2 Years to 9 Years
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Cross-Sectional


Related Conditions & MeSH terms


Locations

Country Name City State
United States Seattle Children's Research Institute Seattle Washington

Sponsors (2)

Lead Sponsor Collaborator
Seattle Children's Hospital Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Community walking activity with the STEPWATCH accelerometer 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 No
Secondary Participation in day to day life activities 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 No
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