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.
Study Type
OBSERVATIONAL
Enrollment
3
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.
Institut Régional de Médecine Physique et de Réadaptation
Nancy, France
Evolution of the distance travelled during the 2MWT between each phase
In m.
Time frame: 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.
Time frame: The VAS was performed after each 2MWT. All 2MWT were completed in one day.
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