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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients suffering from AOA
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| Name | Affiliation | Role |
|---|---|---|
| Jean Paysant, PhD-MD | Institut Régional de Médecine Physique et de Réadaptation | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Régional de Médecine Physique et de Réadaptation | Nancy | 54000 | France |
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