Clinical Trial: Orthotics in Ambulatory Cerebral Palsy

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Relationship of Orthotics to Activity and Participation in Children With Cerebral Palsy

Brief Summary: This project will examine the effect of solid ankle foot orthoses (SAFO) on day to day walking activity and life participation of ambulatory children with cerebral palsy. The investigators propose that SAFO have not effect on levels of walking and life participation versus not wearing the SAFO.

Detailed Summary:

This is a repeated measures trial with randomization of intervention in a cross over design which will quantify daily walking and physical activity levels for children with cerebral palsy (CP) with and without use of a solid ankle foot orthotic (SAFO). Current orthotic management guidelines are based primarily on evidence that SAFO use positively impacts body function and structure in clinic and lab based observations of activity and movement. Prior research has determined that wearing a SAFO improves different aspects of gait and mobility (stride and step length, single limb stance, velocity) for children with CP. However, these studies have been limited by small sample sizes, lack of comparison groups, inconsistency of orthotic fabrication, lack of clear and simple outcome measures and/or randomized control designs. No prior studies have evaluated the effect of SAFO use on activity performance outcomes.

The purpose of this study is to determine the effect of wearing or not wearing current SAFO on a child's walking ability, participation in common life activities, and gait. Children ages 2 - < 10 years who have bilateral cerebral palsy, dynamic equinus gait deformity, and wear bilateral SAFOs fabricated by Cascade DAFO will be approached for participation. Enrolled children are randomly assigned to either wear or not wear their SAFOs for a 14 day intervention period. After this period is over, children will then do the opposite for a second 14 day intervention period. Children attend three study visits; at enrollment, after the first intervention period is over, and after the second intervention period. At the first visit, parents and children (where applicable) complete questionnaires regarding their participation in common life activities in the prior 7 days, and complete a walking evaluation. Children wear a StepWatch accelerometer during each intervention period,
Sponsor: Seattle Children's Hospital

Current Primary Outcome: Walking Activity Levels [ Time Frame: average of 5 days of second week of intervention ]

Daily walking activity will be measured with the StepWatch accelerometer documenting average strides/day.


Original Primary Outcome: Walking Activity Levels [ Time Frame: seven day sample average of 5 days ]

Daily walking activity will be measured with the StepWatch accelerometer documenting average strides/day, percent time active and percentage of time spent at low, medium and high activity levels.


Current Secondary Outcome:

  • Physical Activity Scale for Kids - Performance Version (ASKp) [ Time Frame: previous 7 day reference ]
    Physical activity will be by parental report of Physical Activities Scale for Kids performance version (ASKp) survey- total score. Scale ranges from 0 to 100 with higher scores representing more physical activity. A score of 100 on this criterion referenced evalutive measure is consistent with physical activity like that of a typically developing 5 year old.
  • Assessment of Life Habits for Children (LIFE-H) [ Time Frame: previous 7 day reference ]
    Participation in habits of daily life will be by parental report of the Life Habits questionnaire(Life-H for children) by the weighted total score on a scale of 0 to 9, with a higher score representing more participation in habits of daily life.


Original Secondary Outcome:

  • Physical Activity performance [ Time Frame: previous 7 day reference ]
    Physical activity will be by parental report of Physical Activities Scale for Kids performance version (ASKp) survey
  • Participation in daily life [ Time Frame: previous 7 day reference ]
    Participation in daily life will be by parental report of the Life Habits questionnaire(Life-H for children).


Information By: Seattle Children's Hospital

Dates:
Date Received: January 30, 2012
Date Started: January 2012
Date Completion:
Last Updated: February 3, 2016
Last Verified: February 2016