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

Study Overview
=================
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.

Official Title
-----------------
Efficacity of a Rigid Ankle Foot Orthosis for Persons With Ankle Osteoarthritis

Conditions
-----------------
Ankle Osteoarthritis

Intervention / Treatment
-----------------
* Other: Ankle Foot Orthosis


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
-----------------
Primary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ankle Osteoarthritis, Ankle Foot Orthosis, Ankle Arthrodesis, Single Case Experimental Design