Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT01527162 |
Other study ID # |
K23HD060764-03B |
Secondary ID |
K23HD060764-03 |
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
January 2012 |
Est. completion date |
July 2014 |
Study information
Verified date |
May 2021 |
Source |
Seattle Children's Hospital |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
Description:
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, 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.