NCT02859740已完成不适用
Validation of the SIGAM/VF Mobility Grade
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Answers to the SIGAM mobility scale questionnaire
研究概览
简要总结
The objective of this study is to demonstrate the validity, the reproducibility and the coherence of the French version of the Special Interest Group in Amputee medicine (SIGAM) mobility scale questionnaire in adults with lower-limb amputations.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 to 80 years
- •Patients who have been informed about the research
- •Patients with national health insurance cover
- •Patients who accepted to take part in the study
- •Able to understand simple instructions
- •With transtibial, femoral, or bilateral amputation of the lower limb
- •Whatever the etiology
- •Patients able to do the 2-minute walk test
- •Patients in the stabilized phase of the definitive prosthesis, with no modification of the prosthesis in the previous 3 months and at more than 6 months after the amputation.
- •Patients in the initial phase of management (temporary prosthesis, rehabilitation) post trans-tibial unilateral amputation
排除标准
- •Patient without national health insurance cover.
- •Patients under guardianship.
- •Pregnant or breast-feeding women.
- •Alteration of executive functions making understanding of and compliance with the research protocol impossible (Mini Mental State Examination<20)
- •Associated chronic motor deficiency, of neurological origin (examples: sequelae of stroke, balance and coordination disorders), or of osteo-articular origin (examples: knee or hip osteoarthritis), or due to secondary functional repercussions making it impossible to walk with a prosthesis.
- •Severe medical disorder that significantly impairs functional capacities (severe heart failure, respiratory failure, non-stabilized metabolic disorders such as progressive kidney failure) that is life-threatening in the short or medium term (Progressive neoplastic disease, non-stabilized systemic disease).
- •Complications at the stump other than microcirculation that could affect the application of a contact socket/sleeve: haematoma, Cysts, effusion, calcifications of soft tissues, bone spurs, infection (skin, abscess), neuroma, deterioration of the knee of the amputated limb, specifically painful Farabeuf angle (compression between bone and skin), venous thrombosis, abnormal stump shape making it impossible to use a socket (flexion of the knee, "pear-shaped", "deep-scar" stump...)
结局指标
主要结局
Answers to the SIGAM mobility scale questionnaire
时间窗: Change from baseline at Week 2 and Week 3
次要结局
未报告次要终点
研究者
研究点 (1)
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