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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

3 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-02-01

Study Completion Date

2017-12-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Comparison of the Functional Walking Outcomes of Two Settings of a Commercially Available AFO in Adult Stroke Patients

NCT02122783

Walking Aided by a Leg Brace in Stroke Subjects

COMPLETED NA

Do Rocker Bottom Shoes and Ankle-Foot Orthoses Reduce Pain and Improve Mobility for Ankle Osteoarthritis Patients

NCT03524729

Ankle Osteoarthritis Healthy Ankles

COMPLETED NA

Early Protected Full Weight-bearing vs. Partial Weight-bearing After Surgical Fixation of Unstable Ankle Fractures, Monitored With Bio-feedback Insoles.

NCT06023979

Post Operative Treatment After Unstable Malleolar Fractures

NOT_YET_RECRUITING NA

Comparison of Thermo-plastic Versus Carbon Foot Ankle Orthosis to Improve Gait and Reduce Fatigue in Post-stroke Patients: a Biomechanical and Neurophysiological Study

NCT04323943

Hemiparesis;Poststroke/CVA Gait, Hemiplegic

COMPLETED NA

Contribution of an Off-the-shelf Carbon Ankle Foot Orthosis (AFO) in the Management of Walking Functional Impairment

NCT05131399

Neuropathy (Disorder)

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Ankle Osteoarthritis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No