APOS System Effects in Post-operation Bi-trimalleolar Fracture of Ankle Prospective, Comparative Randomize Trial Study
试验速览
- 阶段
- 1 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- APOS System effects
研究概览
简要总结
The purpose of this study is to evaluate of functional tests and clinical findings with APOS System treatment in patient after bi-trimalleolar fracture of ankle. These functional changes will be evaluated AOFS, FAOS, SF36 and WOMAC scores, walking laboratory GAITRite and clinical examination.
详细描述
Trial design Prospective, comparative, randomize trial. The patients after surgery due to bi or trimalleolar fracture of ankle, that were referred to the physiotherapy treatment, 3 weeks cast and 6 weeks from surgery with full weight bearing indicated by orthopedic
- The population will randomized separated in trail and control group/ Both receive APOS shoes The trial group will receive APOS walking system
- The control group will receive the same walking protocol as the trial group without biomechanics units.
-
st visit: enrollment of patient - 6 weeks post op 1. The patient will be given a full verbal and written explanation regarding the trial and treatment. The patient will sign the informed consent form and will be given a serial number.
-
The screening forms will be completed. 3. Demographic data: date of birth, sex, age and complete medical history, height and previous treatments will be recorded.
-
Physical examination: range of motion, Achilles tendon thickness. The results will be recorded in the CRF 5. Walking test using a laboratory walking GAITRite + 6 minute walk test 6. Fill out questionnaire: FAOS - AOSF - SF36 - WOMAC 7. Adjustment of Apos walking System
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients 18-65 year old
- •Post operation bi- trimalleolar fracture of ankle
- •Download cast after 3 weeks
- •Full Weight bearing after 6 weeks
- •Patients in medical condition to receive physiotherapy treatment
- •Patients who are willing to participate in the trial, to come to all scheduled visits and to sign the informed consent forms.
排除标准
- •Patients suffering muscular or nerve disorders
- •Patients who are unable to use the APOS SYSTEM and can not complete the experimental protocol due to physical or mental handicap
- •Non cooperative patient with the basic rehab program.
结局指标
主要结局
APOS System effects
时间窗: one year
Evaluate with functional tests and clinical findings patient after bi-trimalleolar fracture of ankle with who recive APOS System treatment. Functional changes will be evaluated using FAOS, SF36 and WOMAC scores, walking laboratory GAITRite and clinical examination.
次要结局
- Ankle fracture(one year)