Skip to main content
OpenTrials
Completed

NCT Number: NCT05163782

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

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?

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Foot Drop Mononeuropathies Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Peroneal Neuropathies

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

TOPMED

Québec, Quebec, G1S1C1, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

New ankle foot orthosis with anterior support

Device

New ankle foot orthosis with anterior support developed by Turbomed

Ankle foot orthosis with anterior support

Device

Ankle foot orthosis with anterior support from Turbomed

Ankle foot orthosis from competitor 1

Device

Ankle foot orthosis with posterior support from competitor 1

Ankle foot orthosis from competitor 2

Device

Ankle foot orthosis with posterior support from competitor 2

Primary outcomes

  1. Knee flexion angle during gait

    Time frame: At delivery

    Maximum, minimum and range of motion of the knee flexion angle during gait.

  2. Hip flexion angle during gait

    Time frame: At delivery

    Maximum, minimum and range of motion of the hip flexion angle during gait.

  3. Minimum foot clearance

    Time frame: At delivery

    Minimum foot clearance is defined as the minimum distance between the foot and the ground during swing.

  4. Comfort of participants with orthosis

    Time frame: At delivery

    Comfort is measured with a Likert scale from 1 (not comfortable) to 5 (very comfortable).

  5. 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).

Sponsors and collaborators

Lead sponsor

TOPMED

Other

Collaborators

  • Natural Sciences and Engineering Research Council, Canada
  • Turbomed Orthotics Inc.

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Dec 20, 2021
Registry last updated
Sep 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.