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

NCT04312373 | Completed

• 1 other identifier: IRR-2018-SCED
• Study Type: observational
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Ankle Osteoarthritis

Keywords

Ankle Osteoarthritis; Ankle Foot Orthosis; Ankle Arthrodesis; Single Case Experimental Design

Outcome Measures

Primary Outcomes (2)

• 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.

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients suffering from AOA

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Institut Régional de Médecine Physique et de Réadaptation

Nancy, 54000, France

Location

Study Officials

• Jean Paysant, PhD-MD

  Institut Régional de Médecine Physique et de Réadaptation

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2020
• First Posted: March 18, 2020
• Study Start: February 1, 2017
• Primary Completion: November 1, 2017
• Study Completion: December 30, 2017
• Last Updated: March 18, 2020

Record last verified: 2020-03

Locations

FR (1)