Validation of an Ankle Foot Orthosis With Anterior Support for Foot Drop
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Foot Drop
- Sponsor
- TOPMED
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- Easy to put on orthosis
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
The objective of this research is to compare the new ankle foot orthosis (AFO) with prior support developed by Turbomed, with the AFO with posterior support from Turbomed as well as two competing AFOs currently on the market.
With this research, we seek to answer the following questions:
- Is the new AFO as biomechanically efficient as the AFOs currently on the market?
- Is the new AFO more comfortable than the AFO currently on the market?
- Is the new AFO easier to put on and attach than the AFOs currently on the market?
Investigators
Eligibility Criteria
Inclusion Criteria
- •Foot drop following surgery or an accident (functional calf, without contracture and not spastic)
- •Foot drop following a Cerebral Vascular Accident (with or without spasticity, mild to moderate)
- •Ability to stand and walk alone without technical assistance
- •Ability to communicate comfort/discomfort
Exclusion Criteria
- •Sore to one of the feet
Outcomes
Primary Outcomes
Easy to put on orthosis
Time Frame: At delivery
Easy to put on is measured with a Likert scale from 1 (very difficult) to 5 (very easy).
Knee flexion angle during gait
Time Frame: At delivery
Maximum, minimum and range of motion of the knee flexion angle during gait.
Minimum foot clearance
Time Frame: At delivery
Minimum foot clearance is defined as the minimum distance between the foot and the ground during swing.
Hip flexion angle during gait
Time Frame: At delivery
Maximum, minimum and range of motion of the hip flexion angle during gait.
Comfort of participants with orthosis
Time Frame: At delivery
Comfort is measured with a Likert scale from 1 (not comfortable) to 5 (very comfortable).