Orthotics in Ambulatory Cerebral Palsy (SAFO)
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Relationship of Orthotics to Activity and Participation in Children With Cerebral Palsy|
- Walking activity levels [ Time Frame: seven day sample average of 5 days ] [ Designated as safety issue: No ]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.
- Physical Activity performance [ Time Frame: previous 7 day reference ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]Participation in daily life will be by parental report of the Life Habits questionnaire(Life-H for children).
|Study Start Date:||January 2012|
|Study Completion Date:||July 2014|
|Primary Completion Date:||July 2014 (Final data collection date for primary outcome measure)|
Experimental: SAFO worn
Child wears their prescribed SAFO for 14 days
Device: SAFO worn
Child wears their prescribed SAFO for 14 days by random assignment
Other Name: Solid ankle foot orthoses (SAFO)Other: SAFO not worn
Child does not wear their prescirbed SAFO for 14 days by random assignment
Other Name: Solid ankle foot orthoses (SAFO)
No Intervention: SAFO not worn
Child does not wear the prescribed SAFO for 14 days
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 a previously prescribed 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 (Ferndale, WA) 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, which counts the number of steps the child takes and the time each step was taken. After the second intervention period is complete, the child's participation in the research study is complete. One home visit is conducted at the end of each intervention period, where the questionnaires are repeated, and the StepWatch is downloaded and/or re - calibrated per protocol.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01527162
|United States, Washington|
|Seattle Childrens Research Institute|
|Seattle, Washington, United States, 98121|
|Principal Investigator:||Kristie Bjornson, PT, PhD, PCS||Seattle Children's|