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

Not Applicable

Completed

• Conditions: Foot Drop
• Interventions: 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

• Registration Number: NCT05163782
• Lead Sponsor: TOPMED

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?

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-19
• Study First Submitted: 2021-12-15
• Study First Submitted QC: 2021-12-15
• Study First Posted: 2021-12-20
• Primary Completion: 2022-12-30
• Status Verified: 2023-03
• Study Completion: 2023-06-28
• Last Update Submitted: 2023-09-13
• Last Update Posted: 2023-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
People with foot drop	Ankle foot orthosis from competitor 1	People with left or right foot drop
People with foot drop	Ankle foot orthosis with anterior support	People with left or right foot drop
People with foot drop	Ankle foot orthosis from competitor 2	People with left or right foot drop
People with foot drop	New ankle foot orthosis with anterior support	People with left or right foot drop

Primary Outcome Measures

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

Trial Locations

Locations (1)

TOPMED; 🇨🇦 Québec, Quebec, Canada