search
Back to results

Dimensional 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
TOPMED
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hallux Valgus

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
December 15, 2021
Last Updated
March 2, 2023
Sponsor
TOPMED
Collaborators
Natural Sciences and Engineering Research Council, Canada, Orthèse Hallux Valgus Inc.
search

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

We'll reach out to this number within 24 hrs