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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04312373
Acronym
SCED-SA
Enrollment
3
Registered
2020-03-18
Start date
2017-02-01
Completion date
2017-12-30
Last updated
2020-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ankle Osteoarthritis

Keywords

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

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.

Interventions

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.

Sponsors

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

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Evolution of the distance travelled during the 2MWT between each phase1 day, starting from the baselineIn m.
Evolution of the Visual Analogue Scale (VAS) for walking ankle pain between each phaseThe 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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026