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

Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est

Status: Completed

Conditions: Ankle Osteoarthritis

Treatments: Other: Ankle Foot Orthosis

Study type: Observational

Funder types: Other

Identifiers

NCT04312373

IRR-2018-SCED

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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