Status:
COMPLETED
Orthotics in Ambulatory Cerebral Palsy
Lead Sponsor:
Seattle Children's Hospital
Conditions:
Cerebral Palsy
Eligibility:
All Genders
2-9 years
Phase:
NA
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 tha...
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 an...
Eligibility Criteria
Inclusion
- Age 2 to \<10 years
- Gross Motor Function Classification Scale Score of 1 - 3 (ambulatory)
- Diagnosed with bilateral cerebral palsy
- Has dynamic equinus gait deformity, defined as PROM to neutral, with equinus weight bearing pattern.
- Wears bilateral SAFO more than 8 hours per day for more than one month.
- Has a SAFO prescription of ankle at neutral (zero plantarflexion, with \<10 degrees dorsiflexion).
- The primary goal of the SAFO is to facilitate balance and walking
- Has SAFOs fabricated by Cascade DAFO, Ferndale, WA.
- Parent and child are willing to discontinue SAFO use for two weeks.
Exclusion
- Has visual impairment which limits physical activity.
- Has had lower extremity Botox injections in the past 3 months.
- Is expected to require changes to medications treating the movement disorder during the study period.
- Has an uncontrolled seizure disorder which impacts mobility skills.
- Has had neurosurgical or orthopedic surgeries in the past 6 months.
- Has had other surgeries or procedures in the past two weeks.
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT01527162
Start Date
January 1 2012
End Date
July 1 2014
Last Update
June 16 2021
Active Locations (1)
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1
Seattle Childrens Research Institute
Seattle, Washington, United States, 98121