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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05163782

Enrollment

Registered

2021-12-20

Start date

2021-07-19

Completion date

2023-06-28

Last updated

2023-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Foot Drop

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?

Interventions

DEVICENew ankle foot orthosis with anterior support

New ankle foot orthosis with anterior support developed by Turbomed

DEVICEAnkle foot orthosis with anterior support

Ankle foot orthosis with anterior support from Turbomed

DEVICEAnkle foot orthosis from competitor 1

Ankle foot orthosis with posterior support from competitor 1

DEVICEAnkle foot orthosis from competitor 2

Ankle foot orthosis with posterior support from competitor 2

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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.
Hip flexion angle during gait	At delivery	Maximum, minimum and range of motion of the hip 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.
Comfort of participants with orthosis	At delivery	Comfort is measured with a Likert scale from 1 (not comfortable) to 5 (very comfortable).

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026