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

Completed

• Conditions: Ankle Osteoarthritis

• Registration Number: NCT04312373
• Lead Sponsor: Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est

Brief 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.

Study Timeline

• Study Start: 2017-02-01
• Primary Completion: 2017-11-01
• Study Completion: 2017-12-30
• Study First Submitted: 2020-02-27
• Status Verified: 2020-03
• Study First Submitted QC: 2020-03-17
• Last Update Submitted: 2020-03-17
• Study First Posted: 2020-03-18
• Last Update Posted: 2020-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

• primary or post-traumatic one-sided Ankle osteoarthritis (AOA)
• Able to walk at least two minutes

Exclusion Criteria

• cardiovascular diseases
• respiratory diseases that prevent subjects from performing the walking tests
• neurologic or orthopaedic diseases which could affect their gait (excluding AOA)
• inability to understand study instructions

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evolution of the Visual Analogue Scale (VAS) for walking ankle pain between each phase	The VAS was performed after each 2MWT. All 2MWT were completed in one day.	Scale from 0 to 10, the higher the score the higher the pain.
Evolution of the distance travelled during the 2MWT between each phase	1 day, starting from the baseline	In m.

Trial Locations

Locations (1)

Institut Régional de Médecine Physique et de Réadaptation; 🇫🇷 Nancy, France