Feasibility Study on the Implementation of Local Muscle Vibration as Part of a Rehabilitation Program for Elderly Patients Following Fracture of the Upper End of the Femur
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Feasibility of implementing local muscle vibration sessions
研究概览
简要总结
Fractures of the upper end of the femur in elderly patients are the 2nd most common fracture.
A fracture leads to a syndrome of psychomotor maladjustment, encouraged by pain and aggravated by hospitalisation. In 2014, 50,000 women and 16,000 men suffered this type of fracture every year. The consequences are serious, with a one-year mortality rate of 20 to 24% and an institutionalisation rate of 25%. In 2015, the direct cost of hip fracture in France was estimated at around €1 billion.
In line with the recommendations of the National Institute for Health and Care Excellence (NICE) and the results of meta-analyses, it is recommended that, in the absence of surgical or medical contraindications, patients should be assessed within 24 hours of hip fracture surgery, with a view to initiating early mobilisation and multidisciplinary rehabilitation.
It has been shown in healthy subjects that prolonged application of localised vibrations optimises nerve capacity, leading to an increase in maximum voluntary force.
For population of frail elderly post-operative patients, this localised vibration technique could accelerate and improve functional recovery, particularly in terms of muscle strength, joint mobility and pain. A reduction in muscle loss is hoped for, with benefits in terms of tolerance compared with neurostimulation.
As part of the implementation of the above-mentioned recommendations, the investigators wish to assess the quality of the integration of this technique, already in use in the department on an ad hoc basis, into the organisation of the department and of the patient's care pathway as a complement to the rehabilitation protocols, by identifying the obstacles and facilitating factors. The study will also provide the first estimates of the effect on muscle recovery.
The investigator hypothesise that this local vibration protocol can be integrated into the rehabilitation department's work schedule and into the patient's care pathway, and that it will be acceptable to both the patient and the nursing staff.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 75 or over who have undergone surgery for a fracture of the upper end of the femur
- •Hospitalised in the SMR department no later than D14 of their operation
- •Resource Iso Group greater than or equal to 3 on the Aggir scale
- •Patient capable of consenting who has signed a consent form or patient unable to express consent at the discretion of the principal investigator, informed and not opposed to the study, for whom a trusted person, or if not available, the family, or if not available, a close relative has signed an informed consent within a maximum of 2 days. For patients under guardianship, the guardian's consent will be requested, and for patients under curatorship, the patient will sign the consent in the presence of the curator within a maximum of 2 days as well.
- •Affiliated to a social security scheme
排除标准
- •Persons deprived of their liberty by a judicial or administrative decision
- •Individuals with severe psycho-behavioral disorders (major psychiatric or neurocognitive disorders)
- •Persons admitted to a health or social establishment for purposes other than research
- •Contraindications to electrical stimulation:
- •Patient with active devices such as pacemakers, defibrillators, insulin pumps, neurostimulators, etc
- •Patient with phlebitis or risk of thrombosis
- •Epileptic patient
- •Patient with fragile skin or open wounds on the lower limbs
- •Subject participating in another interventional study with an exclusion period still in progress at pre-inclusion.
研究组 & 干预措施
Subjects aged 75 and over with surgery following a fracture of the upper end of the femur
Patient, aged 75 and over, hospitalised in Medical and Rehabilitation Care no later than D14 of his operation for a fracture of the upper end of the femur
干预措施: Initial Assessment (Diagnostic Test)
Subjects aged 75 and over with surgery following a fracture of the upper end of the femur
Patient, aged 75 and over, hospitalised in Medical and Rehabilitation Care no later than D14 of his operation for a fracture of the upper end of the femur
干预措施: Standard rehabilitation programme combined with local vibration sessions (Device)
Subjects aged 75 and over with surgery following a fracture of the upper end of the femur
Patient, aged 75 and over, hospitalised in Medical and Rehabilitation Care no later than D14 of his operation for a fracture of the upper end of the femur
干预措施: Final assessment (Other)
Subjects aged 75 and over with surgery following a fracture of the upper end of the femur
Patient, aged 75 and over, hospitalised in Medical and Rehabilitation Care no later than D14 of his operation for a fracture of the upper end of the femur
干预措施: Acceptability and satisfaction questionnaire (Other)
结局指标
主要结局
Feasibility of implementing local muscle vibration sessions
时间窗: Week 4 : End of standard rehabilitation protocol plus local vibrations
Completion of local muscle vibration sessions. The operation will be considered complete if 5 sessions lasting 30 minutes per week have been carried out for 4 weeks.
次要结局
- Number of eligible patients not taking part in the study(Week 4 : End of standard rehabilitation protocol plus local vibrations)
- Reasons for not completing sessions and incomplete completion of sessions(Week 4 : End of standard rehabilitation protocol plus local vibrations)
- Tolerability of the muscle vibration technique in real-life care conditions(Week 4 : End of standard rehabilitation protocol plus local vibrations)
- Results after the local muscle vibration technique in terms of variation between the start of rehabilitation and after 4 weeks in following parameters: • Isometric strength (in %)(Week 4 : End of standard rehabilitation protocol plus local vibrations)
- Results after the local muscle vibration technique in terms of variation between the start of rehabilitation and after 4 weeks of the rehabilitation programme in the following parameters: • Physical performance(At 4 weeks - End of standard rehabilitation protocol plus local vibrations)
- Evaluate the results after the local muscle vibration technique in terms of variation between the start of rehabilitation and after 4 weeks of the rehabilitation programme in the following parameters: • Risk of falling(At 4 weeks - End of standard rehabilitation protocol plus local vibrations)
- Results after the local muscle vibration technique in terms of variation between the start of rehabilitation and after 4 weeks of the rehabilitation programme in the following parameters: • Transfers(At 4 weeks - End of standard rehabilitation protocol plus local vibrations)
- Evaluate the results after the local muscle vibration technique in terms of variation between the start of rehabilitation and after 4 weeks of the rehabilitation programme in the following parameters: • Pain(At 4 weeks - End of standard rehabilitation protocol plus local vibrations)
- Measure patients' perceptions of the use of local muscle vibration in their rehabilitation protocol(At 8 weeks - End of protocol)
- Measure the perception of healthcare professionals in the field regarding the use of local muscle vibration as part of their current functional rehabilitation protocol.(At 8 weeks - End of protocol)