Dimensional Validation of the Hallux Valgus Orthosis
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- TOPMED
- Enrollment
- 4
- Locations
- 1
- Primary Endpoint
- Change in pain at 1 month
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Outcomes
Primary Outcomes
Change in pain at 1 month
Time Frame: 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
Time Frame: 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
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported