Validation of an Ankle Foot Orthosis With Anterior Support for Foot Drop
Primary Purpose
Foot Drop
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
New ankle foot orthosis with anterior support
Ankle foot orthosis with anterior support
Ankle foot orthosis from competitor 1
Ankle foot orthosis from competitor 2
Sponsored by
About this trial
This is an interventional treatment trial for Foot Drop
Eligibility Criteria
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
Sites / Locations
- TOPMED
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
People with foot drop
Arm Description
People with left or right foot drop
Outcomes
Primary Outcome Measures
Knee flexion angle during gait
Maximum, minimum and range of motion of the knee flexion angle during gait.
Hip flexion angle during gait
Maximum, minimum and range of motion of the hip flexion angle during gait.
Minimum foot clearance
Minimum foot clearance is defined as the minimum distance between the foot and the ground during swing.
Comfort of participants with orthosis
Comfort is measured with a Likert scale from 1 (not comfortable) to 5 (very comfortable).
Easy to put on orthosis
Easy to put on is measured with a Likert scale from 1 (very difficult) to 5 (very easy).
Secondary Outcome Measures
Full Information
NCT ID
NCT05163782
First Posted
December 15, 2021
Last Updated
September 13, 2023
Sponsor
TOPMED
Collaborators
Turbomed Orthotics Inc., Natural Sciences and Engineering Research Council, Canada
1. Study Identification
Unique Protocol Identification Number
NCT05163782
Brief Title
Validation of an Ankle Foot Orthosis With Anterior Support for Foot Drop
Official Title
Validation of an Ankle Foot Orthosis With Anterior Support for Foot Drop
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
July 19, 2021 (Actual)
Primary Completion Date
December 30, 2022 (Actual)
Study Completion Date
June 28, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TOPMED
Collaborators
Turbomed Orthotics Inc., Natural Sciences and Engineering Research Council, Canada
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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?
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Foot Drop
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
People with foot drop
Arm Type
Experimental
Arm Description
People with left or right foot drop
Intervention Type
Device
Intervention Name(s)
New ankle foot orthosis with anterior support
Intervention Description
New ankle foot orthosis with anterior support developed by Turbomed
Intervention Type
Device
Intervention Name(s)
Ankle foot orthosis with anterior support
Intervention Description
Ankle foot orthosis with anterior support from Turbomed
Intervention Type
Device
Intervention Name(s)
Ankle foot orthosis from competitor 1
Intervention Description
Ankle foot orthosis with posterior support from competitor 1
Intervention Type
Device
Intervention Name(s)
Ankle foot orthosis from competitor 2
Intervention Description
Ankle foot orthosis with posterior support from competitor 2
Primary Outcome Measure Information:
Title
Knee flexion angle during gait
Description
Maximum, minimum and range of motion of the knee flexion angle during gait.
Time Frame
At delivery
Title
Hip flexion angle during gait
Description
Maximum, minimum and range of motion of the hip flexion angle during gait.
Time Frame
At delivery
Title
Minimum foot clearance
Description
Minimum foot clearance is defined as the minimum distance between the foot and the ground during swing.
Time Frame
At delivery
Title
Comfort of participants with orthosis
Description
Comfort is measured with a Likert scale from 1 (not comfortable) to 5 (very comfortable).
Time Frame
At delivery
Title
Easy to put on orthosis
Description
Easy to put on is measured with a Likert scale from 1 (very difficult) to 5 (very easy).
Time Frame
At delivery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edith Martin, PhD
Organizational Affiliation
TOPMED
Official's Role
Principal Investigator
Facility Information:
Facility Name
TOPMED
City
Québec
State/Province
Quebec
ZIP/Postal Code
G1S1C1
Country
Canada
12. IPD Sharing Statement
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Validation of an Ankle Foot Orthosis With Anterior Support for Foot Drop
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