Efficacity of a Rigid Ankle Foot Orthosis for Persons With Ankle Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Evolution of the Visual Analogue Scale (VAS) for walking ankle pain between each phase
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •primary or post-traumatic one-sided Ankle osteoarthritis (AOA)
- •Able to walk at least two minutes
排除标准
- •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
结局指标
主要结局
Evolution of the Visual Analogue Scale (VAS) for walking ankle pain between each phase
时间窗: 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.
Evolution of the distance travelled during the 2MWT between each phase
时间窗: 1 day, starting from the baseline
In m.
次要结局
未报告次要终点