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Efficacity of a Rigid Ankle Foot Orthosis for Persons With Ankle Osteoarthritis — SCED-SA  

Ankle Osteoarthritis Clinical Trial

Official title:
Efficacity of a Rigid Ankle Foot Orthosis for Persons With Ankle Osteoarthritis

Clinical Trial Summary

Ankle osteoarthritis (AOA) is a typical long-term complication of an ankle injury. Pain during walking is the main symptom that limits walking distance. Non-surgical treatments could be used to decrease pain. The gold standard treatment for end-stage OA is definitive surgical ankle arthrodesis.

The purpose of this study was to assess the effectiveness of a rigid ankle-foot orthosis (R-AFO) for walking pain in a population suffering from AOA.

Clinical Trial Description

This study used the SCED introduction/withdrawal methodology to assess the efficacy of R-AFO on pain and walking distance in the 2-minute walk test (2MWT). Each patient is his or her own comparator. During phase A, considered as the baseline, the patient performs the 2MWT without R-AFO. During phases B, considered as the introduction phases, the patient performs the tests with R-AFO. These tests are performed repeatedly and at regular intervals. The time of transition between phases has been randomized to have a minimum of 3 trials per phase.

At the end of each test, an visual analogue scale for the pain and the walking distance travelled during the 2MWT were recorded. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04312373
Study type Observational
Source Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est
Contact
Status Completed
Phase
Start date February 1, 2017
Completion date December 30, 2017
View Details
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