Back to resultsDimensional Validation of the Hallux Valgus Orthosis
Primary Purpose
Hallux Valgus
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Hallux Valgus orthosis
Sponsored by
About this trial
This is an interventional treatment trial for Hallux Valgus
Eligibility Criteria
Inclusion Criteria:
- Painful hallux valgus
- three people maximum per shoe size
Exclusion Criteria:
- People with diabetes ;
- People with severe obesity ;
- People with hallux rigidus;
- People wearing full-time foot orthosis;
- People wearing high heel shoes regularly ;
- People with degenerative disease ;
- People with neuromuscular pathology ;
- People with a circulatory disorder ;
- People who have had major lower body surgery;
- People with epilepsy or with a history of epilepsy.
Sites / Locations
- TOPMED
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Painful Hallux Valgus
Arm Description
Outcomes
Primary Outcome Measures
Change in big toe deviation angle during gait at 1 month
The big toe deviation angle is the angle between the big toe and the gait axis and measured with a motion capture system.
Change in pain at 1 month
Pain is measured with a Likert scale from 1 (decrease of pain) to 5 (increase of pain).
Change in comfort at 1 month
Comfort is measured with a Likert scale from 1 (not comfortable) to 5 (very comfortable).
Secondary Outcome Measures
Full Information
NCT ID
NCT05163431
First Posted
December 15, 2021
Last Updated
March 2, 2023
Sponsor
TOPMED
Collaborators
Natural Sciences and Engineering Research Council, Canada, Orthèse Hallux Valgus Inc.
1. Study Identification
Unique Protocol Identification Number
NCT05163431
Brief Title
Dimensional Validation of the Hallux Valgus Orthosis
Official Title
Dimensional Validation of the Hallux Valgus Orthosis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
July 20, 2021 (Actual)
Primary Completion Date
September 30, 2022 (Actual)
Study Completion Date
September 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TOPMED
Collaborators
Natural Sciences and Engineering Research Council, Canada, Orthèse Hallux Valgus Inc.
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 goal of this project is to optimize the design of the orthosis by establishing the key volumetric characteristics of the custom iterations in order to subsequently transpose them to a standard model and establish the increment proportions of the different sizes. The final product should reduce the pain by repositioning the phalanges of the first toe with the first metatarsal in its axis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hallux Valgus
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Painful Hallux Valgus
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Hallux Valgus orthosis
Intervention Description
Custom designed orthosis and manufactured by 3D printing.
Primary Outcome Measure Information:
Title
Change in big toe deviation angle during gait at 1 month
Description
The big toe deviation angle is the angle between the big toe and the gait axis and measured with a motion capture system.
Time Frame
At baseline and 1 month
Title
Change in pain at 1 month
Description
Pain is measured with a Likert scale from 1 (decrease of pain) to 5 (increase of pain).
Time Frame
At baseline and 1 month
Title
Change in comfort at 1 month
Description
Comfort is measured with a Likert scale from 1 (not comfortable) to 5 (very comfortable).
Time Frame
At baseline and 1 month
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:
Painful hallux valgus
three people maximum per shoe size
Exclusion Criteria:
People with diabetes ;
People with severe obesity ;
People with hallux rigidus;
People wearing full-time foot orthosis;
People wearing high heel shoes regularly ;
People with degenerative disease ;
People with neuromuscular pathology ;
People with a circulatory disorder ;
People who have had major lower body surgery;
People with epilepsy or with a history of epilepsy.
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
Learn more about this trial
Dimensional Validation of the Hallux Valgus Orthosis
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