Activity and Participation in Ambulatory Cerebral Palsy

NCT01217242 | Completed

• 1 other identifier: K23HD060764
• Study Type: observational
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy

Keywords

cerebral palsy; walking activity; physical activity; participation; activity performance; activity capacity

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Participation in day to day life activities

  Assessed as one time point by parental/child report of participation in the last 4 months

Study Arms (1)

Children with cerebral palsy (CP)

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

Eligibility Criteria

• Age: 2 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children with cerebral palsy (CP) or developmental movement disorder before age two who are able to walk

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Seattle Children's Hospital: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Seattle Children's Research Institute

Seattle, Washington, 98101, United States

Location

MeSH Terms

Conditions

Cerebral Palsy; Motor Activity

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Behavior

Study Officials

• Carol Nicholson, MD

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

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor Pediatrics

Study Record Dates

• First Submitted: October 4, 2010
• First Posted: October 8, 2010
• Study Start: August 1, 2009
• Primary Completion: August 1, 2011
• Study Completion: December 1, 2011
• Last Updated: January 5, 2012

Record last verified: 2012-01

Locations

US (1)