Orthotics in Ambulatory Cerebral Palsy
Completed · Not applicable
Conditions studied: Cerebral Palsy
In brief
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.
Key facts
- Study ID
- NCT01527162
- Run by
- Seattle Children's Hospital
- People needed
- 11
- Starts
- 2012-01-01
- Expected to finish
- 2014-07-01
- Last updated by the study team
- 2021-06-16
Who can join
Age: 2 and older, up to 9. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Seattle Childrens Research Institute — Seattle, Washington, United States
Full record on ClinicalTrials.gov
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