Validation of an Ankle Foot Orthosis With Anterior Support for Foot Drop

Study Overview
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Brief Summary
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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?

Official Title
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Validation of an Ankle Foot Orthosis With Anterior Support for Foot Drop

Conditions
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Foot Drop

Intervention / Treatment
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* Device: New ankle foot orthosis with anterior support
* Device: Ankle foot orthosis with anterior support
* Device: Ankle foot orthosis from competitor 1
* Device: Ankle foot orthosis from competitor 2


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: People with foot drop<br>People with left or right foot drop | Device: New ankle foot orthosis with anterior support<br>* New ankle foot orthosis with anterior support developed by Turbomed<br>Device: Ankle foot orthosis with anterior support<br>* Ankle foot orthosis with anterior support from Turbomed<br>Device: Ankle foot orthosis from competitor 1<br>* Ankle foot orthosis with posterior support from competitor 1<br>Device: Ankle foot orthosis from competitor 2<br>* Ankle foot orthosis with posterior support from competitor 2<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee flexion angle during gait | Maximum, minimum and range of motion of the knee flexion angle during gait. | At delivery | 
| Hip flexion angle during gait | Maximum, minimum and range of motion of the hip flexion angle during gait. | At delivery | 
| Minimum foot clearance | Minimum foot clearance is defined as the minimum distance between the foot and the ground during swing. | At delivery | 
| Comfort of participants with orthosis | Comfort is measured with a Likert scale from 1 (not comfortable) to 5 (very comfortable). | At delivery | 
| Easy to put on orthosis | Easy to put on is measured with a Likert scale from 1 (very difficult) to 5 (very easy). | At delivery |