NCT04312373

Efficacity of a Rigid Ankle Foot Orthosis for Persons With Ankle Osteoarthritis

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 3 (actual)
• Sponsor: Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Ankle Osteoarthritis

Interventions

Type	Name	Description
OTHER	Ankle Foot Orthosis	According to the SCED methodology, patients were fitted with ankle foot orthosis intermittently, during 4 phases, in the following order : without orthosis (A1), with orthosis (B1), again without orthosis (A2) and again with orthosis (B2). All the phases were carried out over one day.

Timeline

• Start date: 2017-02-01
• Primary completion: 2017-11-01
• Completion: 2017-12-30
• First posted: 2020-03-18
• Last updated: 2020-03-18

Locations

1 site across 1 country: France