Evaluation of Ankle Propriocement and Stability in Patients Affected by Traumatic Lateral Ankle Instability Before and After External Ankle Ligament Recontruction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- American Orthopaedic Foot & Ankle score (AOFAs) questionnaire
研究概览
简要总结
The objective of the study is to evaluate the postural control and proprioception before and after external capsulo-ligament reconstruction for ankle instability.
详细描述
The objective of the study is to evaluate the postural control and proprioception before and after external capsulo-ligament reconstruction for ankle instability using differents tests, questionnaires and instrument:
- Delos system (computerized oscillating platform)
- Foot and Ankle Ability Measure (FAAM), l'American Orthopaedic Foot and Ankle Score (AOFAs), SF12 questionnaires
- modified Star Excursional Balance Test (mSEBT) and Short Physical Performance Battery (SPPB)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients who must undergo surgery;
- •patients of both sexes aged between 18-40 years;
- •patients who have given their informed written consent to participate in the study;
- •patients who have given their consent to reach the Hospital to perform the 4-month check-up
排除标准
- •patients with BMI> 30 kg / m2;
- •patients with rheumatoid arthritis;
- •patients with chronic inflammatory joint diseases;
- •patients with pre-existing abnormalities of the ambulatory kinematics (amputations, neuro-muscular diseases, polio, hip dysplasias);
- •patients with Severe arthrosis of the ankle (Kellgren-Lawrence> 3);
- •patients with Severe knee arthritis (Kellgren-Lawrence> 3);
- •patients with ACL injury;
- •patients with severe postural instability;
- •patients with cognitive impairments;
- •patients with concomitant neurological diseases.
结局指标
主要结局
American Orthopaedic Foot & Ankle score (AOFAs) questionnaire
时间窗: End of the study, 18 month from the beginning (04 August 2020)
AOFAs: values from 0 to 100 dependent on limitations in performing activities
modified Star Excursional Balance Test (mSEBT) functional test
时间窗: End of the study, 18 month from the beginning (04 August 2020)
mSEBT: best value resulting from the 3 equilibrium tests standardized for the length of the limb. The tests consist in reaching the greater distance with a foot along three (inverted Y-shaped) axes with between them an angle of 90 ° (rear) and two of 135 ° (antero-medial and anterior-lateral) while the opposite foot remains still on the ground
Short Physical Performance Battery functional test
时间窗: End of the study, 18 month from the beginning (04 August 2020)
The SPPB scale is a short battery of tests designed to evaluate the functionality of the lower limbs. This battery consists of 3 different sections. The total score of the scale has a range from 0 to 12.
Delos (computerized oscillating platform)
时间窗: End of the study, 18 month from the beginning (04 August 2020)
The patients will be analyzed pre and postoperatively using a computerized oscillating platform that shows the response of the foot as an adaptation to the ground. The result is expressed through stability index (%) compared to the average of the population.
Foot & Ankle Ability Measure (FAAM) questionnaire.
时间窗: End of the study, 18 month from the beginning (04 August 2020)
FAAM: expresses the personal evaluation of the patient on his difficulty in performing activities using 5 values for each question: no difficulty, slight difficulty, moderate difficulty, extreme difficulty, inability.
Short Form Health Survey - 12 questionnaire
时间窗: End of the study, 18 month from the beginning (04 August 2020)
SF12: personal assessment of one's state of health using multiple-answer questions with different values for each question.
次要结局
未报告次要终点