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Orthotics in Ambulatory Cerebral Palsy (SAFO)

This study is currently recruiting participants.
Verified March 2013 by Seattle Children's Hospital
Sponsor:
Information provided by (Responsible Party):
Kristie Bjornson, Seattle Children's Hospital
ClinicalTrials.gov Identifier:
NCT01527162
First received: January 30, 2012
Last updated: March 14, 2013
Last verified: March 2013
History of Changes
  Purpose

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 Intervention Phase
Cerebral Palsy
 Other: SAFO worn or on
 Phase 3

Study Type: Interventional
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Seattle Children's Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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).


Estimated Enrollment: 60
Study Start Date: January 2012
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SAFO worn or on
Child wears their prescribed SAFO for 14 days
 Other: SAFO worn or on
Child wears their prescribed SAFO for 14 days by random assignment
Other Name: Solid ankle foot orthoses (SAFO)

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 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.

  Eligibility

Ages Eligible for Study:   2 Years to 9 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01527162

Locations
United States, Washington
Seattle Childrens Research Institute Recruiting
Seattle, Washington, United States, 98121
Contact: Kristie F Bjornson, PT, PHD, PCS     206-884-2066     kristie.bjornson@seattlechildrens.org    
Contact: Nadine Bolliger, BS     206-884-2756     nadine.bolliger@seattlechildrens.org    
Principal Investigator: Kristie F Bjornson, PT,PHD, PCS            
Sponsors and Collaborators
Seattle Children's Hospital
Investigators
Principal Investigator: Kristie Bjornson, PT, PhD, PCS Seattle Children's
  More Information

No publications provided

Responsible Party: Kristie Bjornson, Principal Investigator, Seattle Children's Hospital
ClinicalTrials.gov Identifier: NCT01527162     History of Changes
Other Study ID Numbers: K23HD060764-03B
Study First Received: January 30, 2012
Last Updated: March 14, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Seattle Children's Hospital:
Cerebral palsy
orthotics
solid ankle foot orthoses

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

ClinicalTrials.gov processed this record on May 23, 2013