Hallux Valgus
Conditions
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.
Interventions
DEVICEHallux Valgus orthosis
Custom designed orthosis and manufactured by 3D printing.
Sponsors
Natural Sciences and Engineering Research Council, Canada
Orthèse Hallux Valgus Inc.
TOPMED
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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). |
Countries
Canada
Outcome results
None listed