Trial record 1 of 15 for:    cerebral palsy orthotics
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Orthotics in Ambulatory Cerebral Palsy (SAFO)

This study has been completed.
Information provided by (Responsible Party):
Kristie Bjornson, Seattle Children's Hospital Identifier:
First received: January 30, 2012
Last updated: November 17, 2014
Last verified: November 2014

January 30, 2012
November 17, 2014
January 2012
July 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01527162 on Archive Site
  • 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).
Same as current
Not Provided
Not Provided
Orthotics in Ambulatory Cerebral Palsy
Relationship of Orthotics to Activity and Participation in Children With Cerebral Palsy

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.

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.

Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Cerebral Palsy
  • 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)
  • Experimental: SAFO worn
    Child wears their prescribed SAFO for 14 days
    • Device: SAFO worn
    • Other: SAFO not worn
  • No Intervention: SAFO not worn
    Child does not wear the prescribed SAFO for 14 days
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
July 2014
July 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Age 2 to <10 years
  2. Gross Motor Function Classification Scale Score of 1 - 3 (ambulatory)
  3. Diagnosed with bilateral cerebral palsy
  4. Has dynamic equinus gait deformity, defined as PROM to neutral, with equinus weight bearing pattern.
  5. Wears bilateral SAFO more than 8 hours per day for more than one month.
  6. Has a SAFO prescription of ankle at neutral (zero plantarflexion, with <10 degrees dorsiflexion).
  7. The primary goal of the SAFO is to facilitate balance and walking
  8. Has SAFOs fabricated by Cascade DAFO, Ferndale, WA.
  9. Parent and child are willing to discontinue SAFO use for two weeks.

Exclusion Criteria:

  1. Has visual impairment which limits physical activity.
  2. Has had lower extremity Botox injections in the past 3 months.
  3. Is expected to require changes to medications treating the movement disorder during the study period.
  4. Has an uncontrolled seizure disorder which impacts mobility skills.
  5. Has had neurosurgical or orthopedic surgeries in the past 6 months.
  6. Has had other surgeries or procedures in the past two weeks.
2 Years to 9 Years
Contact information is only displayed when the study is recruiting subjects
United States
Kristie Bjornson, Seattle Children's Hospital
Seattle Children's Hospital
Not Provided
Principal Investigator: Kristie Bjornson, PT, PhD, PCS Seattle Children's
Seattle Children's Hospital
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP