Orthotics in Ambulatory Cerebral Palsy (SAFO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01527162
Recruitment Status : Completed
First Posted : February 6, 2012
Results First Posted : February 4, 2016
Last Update Posted : February 4, 2016
Information provided by (Responsible Party):
Kristie Bjornson, Seattle Children's Hospital

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.

Condition or disease Intervention/treatment Phase
Cerebral Palsy Device: SAFO worn Other: SAFO not worn Phase 3

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

  2. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 9 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01527162

United States, Washington
Seattle Childrens Research Institute
Seattle, Washington, United States, 98121
Sponsors and Collaborators
Seattle Children's Hospital
Principal Investigator: Kristie Bjornson, PT, PhD, PCS Seattle Children's

Responsible Party: Kristie Bjornson, Principal Investigator, Seattle Children's Hospital Identifier: NCT01527162     History of Changes
Other Study ID Numbers: K23HD060764-03B
K23HD060764-03 ( U.S. NIH Grant/Contract )
First Posted: February 6, 2012    Key Record Dates
Results First Posted: February 4, 2016
Last Update Posted: February 4, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Kristie Bjornson, Seattle Children's Hospital:
Cerebral palsy
solid ankle foot orthoses

Additional relevant MeSH terms:
Cerebral Palsy
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases