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

Ankle Osteoarthritis Clinical Trial

— SCED-SA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04312373
• Other study ID #: IRR-2018-SCED
• Status: Completed
• Start date: February 1, 2017
• Est. completion date: December 30, 2017

Study information

• Verified date: March 2020
• Source: Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: December 30, 2017
• Est. primary completion date: November 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ankle Osteoarthritis
• Osteoarthritis

Intervention

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.

Locations

Country	Name	City	State
France	Institut Régional de Médecine Physique et de Réadaptation	Nancy

Sponsors (1)

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

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evolution of the distance travelled during the 2MWT between each phase	In m.	1 day, starting from the baseline
Primary	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.