Mucle Resilience: Muscular Markers Predictive of Functional Recovery After Femoral Neck Fracture in Orthogeriatrics
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 4
- 主要终点
- HD-sEMG correlated to SPPB
研究概览
简要总结
The aging of the population is a major public health problem, particularly with regard to the quality of life and the maintenance of autonomy.
The fracture of the upper end of the femur (EFSF) is a pathology:
- Frequent, affecting the elderly: in France, 80,000 patients / year, 83% aged ≥ 75 years (DREES, 2011),
- severe, on mortality and autonomy: 40% will not recover their walking capacity earlier than 6 months, 13% of patients > 85 years old walk unaided at 4 months and 11% of patients will be newly admitted to an institution in 6 months after the fracture (UPOG / PSL data).
- and costly: costs related to acute care (excluding prostheses and osteosynthesis equipment), are estimated at € 475 million for health insurance in France.
Currently, despite optimized orthogeriatric management, it is difficult to predict how the individual will respond / recover from acute stress related to the EFSF. Physical resilience is an emerging concept in medicine that defines the dynamic ability of a subject to resist or recover from functional decline as a result of stress or disruption. In this context, developing new approaches to assessing resilience is important, to take into account this resilience specific to each patient in order to develop a personalized functional rehabilitation strategy. The objective of the HIPRESM study is to be able to identify, in elderly patients after an EFSF intervention, the muscular signature associated with good functional recovery (= physical resilience). The goal of the investigators is to develop software that will provide this muscle signature by measuring and analyzing parameters from high-definition surface electromyography (HD-sEMG). This technology is innovative, non-invasive and portable, CE marked but not yet used in clinical routine.
详细描述
The aging of the population is a major public health problem with its multifactorial impact, quality of life and the maintenance of autonomy.
The upper femoral fracture (UFF) is a common pathology: in France, it concerns nearly 80.000 patients per year, 83% of whom are aged 75 (DREES, 2011).
The UFF is a pathology with serious consequences, on the mortality but also on the functional level, since 40% of the patients will not recover their walking capacity previous to 6 months, only 13% of the patients over 85 years old will walk unaided to 4 months and 11% of patients will be newly admitted to an institution within 6 months of the fracture (UPOG data, 20% for patients with major neurocognitive disorders, 4% for others). In the literature, at least 25% of elderly people will not recover their previous walking ability, especially for transfers, walking and climbing stairs (Alarcon 2011, Arinzon 2010, Visser 2000).
The UFF is an expensive pathology, whose costs related to acute care (excluding prostheses and osteosynthesis equipment), are estimated at € 475 million in health insurance in France.
Currently, despite optimized orthogeriatric management, it is difficult to predict how the individual will respond/recover from acute UFF-related stress. Physical resilience is an emerging concept in medicine, which defines the dynamic ability of a subject to resist or recover from a functional decline due to stress or disruption. In this context, developing new approaches to assess resilience is important, to take into account each patient's specific resilience in order to develop a personalized functional rehabilitation strategy. The objective of the HIPRESM study is to identify, in older patients after a UFF intervention, the muscle signature associated with good functional recovery (= physical resilience). The objective of the investigators is to identify the parameters derived from high definition surface electromyography (HD-sEMG) by developing software that will provide this muscle signature. This technology is innovative, non-invasive and portable, and already CE marked.
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
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient ≥ 70 years old
- •Managed by orthogeriatric unit after upper femoral fracture surgery
- •Patient informed of the study and who has not objected to his participation.
排除标准
- •Patient bedridden before the femoral fracture, with limited autonomy to bed-chair transfers
- •Any other associated fracture
- •Cutaneous allergy with adhesive plaster
- •BMI ≥ 30 kg / m²
- •Cognitive disorders preventing the correct execution of the movement
结局指标
主要结局
HD-sEMG correlated to SPPB
时间窗: Day 30
Identify HD-sEMG parameters and mesured them during quadriceps muscle extension on lower limb not affected by surgery in the 7th days after UFF surgery, associated to functional status without human assistance (SPPB) at Day 30.
次要结局
- 5 meters Walking speed at Day 30(Day 30)
- Walking ability at Day 30(Day 30)
- Patient autonomy at Day 30(Day 30)
- Rehospitalization delay(Day 30)
- Length of stay in rehabilitation care and Orthogeriatric sector(Day 30)
- Quality of life at Day 30: European Quality of Life-5 Dimensions questionnaire(Day 30)
- HD-sEMG parameters at Day 30(Day 30)
- Intra hospital Mortality(Day 30)