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

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.

Study Overview

• Status: Completed
• Conditions: Ankle Osteoarthritis
• Intervention / Treatment: Other: Ankle Foot Orthosis

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 Type: Observational
• Enrollment (Actual): 3

Contacts and Locations

Study Locations

• France
  • Nancy, France, 54000
    • Institut Régional de Médecine Physique et de Réadaptation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients suffering from AOA

Description

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 Plan

How is the study designed?

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.

Collaborators and Investigators

• Sponsor: Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est
• Investigators: Study Chair: Jean Paysant, PhD-MD, Institut Régional de Médecine Physique et de Réadaptation

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2017
• Primary Completion (ACTUAL): November 1, 2017
• Study Completion (ACTUAL): December 30, 2017

Study Registration Dates

• First Submitted: February 27, 2020
• First Submitted That Met QC Criteria: March 17, 2020
• First Posted (ACTUAL): March 18, 2020

Study Record Updates

• Last Update Posted (ACTUAL): March 18, 2020
• Last Update Submitted That Met QC Criteria: March 17, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Single Case Experimental Design; Ankle Foot Orthosis; Ankle Osteoarthritis; Ankle Arthrodesis
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: IRR-2018-SCED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No