N/A
Completed N=11
Orthotics in Ambulatory Cerebral Palsy
Source: ClinicalTrials.gov NCT01527162 ↗Enrolled (actual)
11
Serious AEs
0.0%
Results posted
Feb 2016
Primary outcomePrimary: Walking Activity Levels — 4660; 4897 average total strides/day — p=< 0.05
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Walking Activity Levels |
4660; 4897 | < 0.05 sig |
| SECONDARY Physical Activity Scale for Kids - Performance Version (ASKp) |
51.08; 49.45 | = 0.14 |
| SECONDARY Assessment of Life Habits for Children (LIFE-H) |
5.71; 5.11 | >.54 |
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT01527162). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.