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

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.

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Key information

Conditions

Ankle Osteoarthritis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Institut Régional de Médecine Physique et de Réadaptation

Nancy, 54000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ankle foot orthosis

Other

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.

Primary outcomes

Evolution of the distance travelled during the 2MWT between each phase

Time frame: 1 day, starting from the baseline

In m.
Evolution of the Visual Analogue Scale (VAS) for walking ankle pain between each phase

Time frame: 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.

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Acronym: SCED-SA

Important dates

Study start: 2017
Primary completion: 2017
Study completion: 2017
First posted: Mar 18, 2020
Registry last updated: Mar 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed