- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04312373
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
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Nancy, France, 54000
- Institut Régional de Médecine Physique et de Réadaptation
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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?
Design Details
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
Time Frame: 1 day, starting from the baseline
|
In m.
|
1 day, starting from the baseline
|
Evolution of the Visual Analogue Scale (VAS) for walking ankle pain between each phase
Time Frame: The 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.
|
The VAS was performed after each 2MWT. All 2MWT were completed in one day.
|
Collaborators and Investigators
Investigators
- Study Chair: Jean Paysant, PhD-MD, Institut Régional de Médecine Physique et de Réadaptation
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRR-2018-SCED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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