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

TOPMED

Status: Completed

Conditions: Foot Drop

Treatments: Device: Ankle foot orthosis from competitor 2; Device: Ankle foot orthosis with anterior support; Device: Ankle foot orthosis from competitor 1; Device: New ankle foot orthosis with anterior support

Study type: Interventional

Funder types: Other

Identifiers

NCT05163782

RD-19-0276_OptOrPi

Details and patient eligibility

About

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?

Enrollment: 18 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

People with foot drop

Experimental group

Description:

People with left or right foot drop

Treatment:

Device: Ankle foot orthosis from competitor 2

Device: Ankle foot orthosis from competitor 1

Device: New ankle foot orthosis with anterior support

Device: Ankle foot orthosis with anterior support