Dimensional Validation of the Hallux Valgus Orthosis

Not Applicable

Completed

• Conditions: Hallux Valgus
• Interventions: Device: Hallux Valgus orthosis

• Registration Number: NCT05163431
• Lead Sponsor: TOPMED

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-20
• Study First Submitted: 2021-12-15
• Study First Submitted QC: 2021-12-15
• Study First Posted: 2021-12-20
• Primary Completion: 2022-09-30
• Study Completion: 2022-09-30
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-02
• Last Update Posted: 2023-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Painful Hallux Valgus	Hallux Valgus orthosis	-

Primary Outcome Measures

Name	Time	Method
Change in pain at 1 month	At baseline and 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	At baseline and 1 month	Comfort is measured with a Likert scale from 1 (not comfortable) to 5 (very comfortable).
Change in big toe deviation angle during gait at 1 month	At baseline and 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.

Trial Locations

Locations (1)

TOPMED; 🇨🇦 Québec, Quebec, Canada