Orthotics in Ambulatory Cerebral Palsy (SAFO)
|ClinicalTrials.gov Identifier: NCT01527162|
Recruitment Status : Completed
First Posted : February 6, 2012
Results First Posted : February 4, 2016
Last Update Posted : February 4, 2016
|Condition or disease||Intervention/treatment||Phase|
|Cerebral Palsy||Device: SAFO worn Other: SAFO not worn||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Relationship of Orthotics to Activity and Participation in Children With Cerebral Palsy|
|Study Start Date :||January 2012|
|Actual Primary Completion Date :||July 2014|
|Actual Study Completion Date :||July 2014|
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
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01527162
|United States, Washington|
|Seattle Childrens Research Institute|
|Seattle, Washington, United States, 98121|
|Principal Investigator:||Kristie Bjornson, PT, PhD, PCS||Seattle Children's|