Early Phase 1
N=11
Testing an Adjustable Ankle Orthosis During Walking in Cerebral Palsy
Cerebral Palsy
Bottom Line
View on ClinicalTrials.gov: NCT06262191 ↗Enrolled (actual)
11
Serious AEs
0.0%
Results posted
May 2025
Primary outcome: Primary: Change in Muscle Activity — -0.09 percent change based on mV/mV measures
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- Differential and adjustable stiffness AFO (DAS-AFO) (Device)
- Age
- Pediatric, Adult · 8+ yrs
- Sex
- All
- Sponsor
- Northern Arizona University
- Primary completion
- Jun 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Muscle Activity |
-0.09 | — |
| PRIMARY Change in Metabolic Cost of Transport |
0.57 | — |
| PRIMARY Change in Ankle Power |
0.01 | — |
Summary
This study seeks to determine how an adjustable stiffness ankle braces affects walking performance and biomechanics in cerebral palsy.
Eligibility Criteria
Inclusion Criteria
- Age between 8-35 years old, inclusive
- Diagnosis of cerebral palsy (CP)
- Gross motor functional classification score level I, II, or III
- Physician-prescribed AFOs of common design (i.e., rigid molded thermoplastic)
- Ability to walk for 6 minutes on a treadmill
- At least 20° of passive plantar-flexion range of motion
- No concurrent treatment other than those assigned during the study
- No condition other than CP that would affect safe participation
- No surgery within 6 months of participation.
Exclusion Criteria
-Excessive knee flexion during walking caused by CP
Data sourced from ClinicalTrials.gov (NCT06262191). 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.