Activity and Participation in Ambulatory Cerebral Palsy

NCT ID: NCT01217242

Last Updated: 2012-01-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 128 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-08-31
• Study Completion Date: 2011-12-31

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

Conditions

Cerebral Palsy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Children with cerebral palsy (CP)

ages 2 to \< 10 years who are able to walk with or without an assistive device

No interventions assigned to this group

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.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 9 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

NIH

Sponsor Role: collaborator

Seattle Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Kristie Bjornson

Assistant Professor Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Carol Nicholson, MD

Role: STUDY_DIRECTOR

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

Locations

Seattle Children's Research Institute

Seattle, Washington, United States

Countries

United States

Other Identifiers

K23HD060764

Identifier Type: NIH

Identifier Source: secondary_id

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K23HD060764

Identifier Type: NIH

Identifier Source: org_study_id

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