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

Foot Drop Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05163782
• Other study ID #: RD-19-0276_OptOrPi
• Status: Completed
• Phase: N/A
• Start date: July 19, 2021
• Est. completion date: June 28, 2023

Study information

• Verified date: March 2023
• Source: TOPMED
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: June 28, 2023
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Foot Drop
• Peroneal Neuropathies

Intervention

Device:
• New ankle foot orthosis with anterior support
New ankle foot orthosis with anterior support developed by Turbomed
• Ankle foot orthosis with anterior support
Ankle foot orthosis with anterior support from Turbomed
• Ankle foot orthosis from competitor 1
Ankle foot orthosis with posterior support from competitor 1
• Ankle foot orthosis from competitor 2
Ankle foot orthosis with posterior support from competitor 2

Locations

Country	Name	City	State
Canada	TOPMED	Québec	Quebec

Sponsors (3)

Lead Sponsor	Collaborator
TOPMED	Natural Sciences and Engineering Research Council, Canada, Turbomed Orthotics Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Knee flexion angle during gait	Maximum, minimum and range of motion of the knee flexion angle during gait.	At delivery
Primary	Hip flexion angle during gait	Maximum, minimum and range of motion of the hip flexion angle during gait.	At delivery
Primary	Minimum foot clearance	Minimum foot clearance is defined as the minimum distance between the foot and the ground during swing.	At delivery
Primary	Comfort of participants with orthosis	Comfort is measured with a Likert scale from 1 (not comfortable) to 5 (very comfortable).	At delivery
Primary	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