A Study Comparing the Use of Cross-education of Strength-training for the Non-injured Limb With Traditional Rehabilitation After Conservatively Managed Proximal Humerus Fractures in Adult Patients
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 40
- 主要终点
- Oxford Shoulder Score
研究概览
简要总结
Proximal humerus fractures (break of the top part of the upper arm bone) are common in older people with poorer bone quality. Often patients do not undergo surgery for these fractures: the bone fragments may be in an acceptable enough position to be able to heal naturally, or the patient may not be well enough medically to undergo an operation. These patients need to wear a sling to immobilise their injured shoulder, however muscles start to weaken quickly when they are unable to be used. This research project will look at whether strength-training the opposite/uninjured limb, known as "cross education", has any effect on preserving the function of the injured/fractured limb. Participants will be randomised into two groups using minimisation, that is to say the groups will have balanced numbers in terms of exact pattern of fracture and gender. One group will receive traditional rehabilitation exercises and treatment by the physiotherapist for their injured limb; the other group will receive the same but in addition will also undergo a strength-training exercise programme for their uninjured limb. Only qualified physiotherapists with experience of treating this patient cohort will be involved. Sessions in the physiotherapy department will last up to 30 minutes each and will comprise of: patient review, exercise progression, and advice giving/question answering; home exercise programmes will be expected to be completed 2-3 times daily and last up to 30 minutes each; number of sessions will be agreed between the participant and treating physiotherapist with treating ending once an agreed, acceptable level of function has been achieved. The Oxford Shoulder Score patient-reported outcome measure will be completed by the participant at 6 and 12 weeks and the European Quality of Life (EuroQoL)-5D-5L at 12 weeks after commencement of treatment.
详细描述
This study will investigate the use of cross education (ie. strength-training the uninjured limb) as part of the recovery and return to function for skeletally mature, adult patients as measured by the Oxford Shoulder Score after proximal humerus fracture and answer the question:
does the use of a strength-training programme for the non-injured limb affect return to function in adult patients with proximal humerus fractures?
Proximal humerus fractures (break to the top part of the upper arm bone) are common, accounting for 4-6% of all fractures in the older population and almost one-fifth of all fractures sustained after a fall from a standing height in patients with osteoporosis. These fractures can functionally impair the upper limb and so impact on overall quality of life. Some studies show that a number of previously fit and independent patients may not return to independent activity following a proximal humerus fracture and may even be at increased risk for sustaining a subsequent fractured hip/neck of femur. If new rehabilitation approaches can help improve the level of function achieved the morbidity and quality of life of these patients could potentially be improved.
The ageing population of the United Kingdom means the number of patients sustaining these fractures will increase and so increase the cost to the National Health Service and the risk of morbidity/mortality/disability/poor health-related quality of life. Treatment needs to address range of movement (ROM) and muscle strength as well as restoration of function and access to the community as quickly as possible. Effective, timely and cost-efficient management of these patients must be found.
Patients with proximal humerus fractures generally undergo a period of wearing a sling to immobilise the limb/stop them from moving it- especially those being managed without an operation. Different orthopaedic and physiotherapy teams across the UK use different periods of immobilisation, start rehabilitation at different times after injury and use different rehabilitation methods. Only a few randomised controlled trials (RCTs) exist looking into when to start physiotherapy and exactly what physiotherapy to do. Studies are needed to develop treatment and rehabilitation protocols to deliver the best and most cost-effective patient care possible.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Proximal humerus fracture <2 weeks old
- •Isolated injury sustained
- •After low-energy trauma (i.e. simple fall from standing; high-energy injuries often have concurrent injuries or require surgery)
- •For conservative management
- •English speaking/understanding (for the duration of the pilot; the full study could be extended to include use of translated information and interpreters)
- •Independent living at the time of injury (i.e. not institutionalised, so measure of function is a relevant outcome)
排除标准
- •Concurrent injuries
- •Fractured shaft of or distal humerus
- •Pathological fracture (due to cancer) or fracture as a result of high energy trauma
- •Previous fracture or pathology to either side
- •History of upper extremity neurological problems (e.g. multiple sclerosis, stroke, Parkinson's disease, vestibular disorders, reflex neuropathy)
- •Diagnosis of dementia/other cognitive impairment
- •Not able to attend the Trust's outpatient departments for rehabilitation
结局指标
主要结局
Oxford Shoulder Score
时间窗: 12 weeks after injury
次要结局
- EuroQoL-5D-5L(at 6 weeks & 12 weeks after injury)
- Oxford Shoulder Score(at 6 weeks after injury)
研究者
Jenna Bardsley
Principle Investigator
Liverpool University Hospitals NHS Foundation Trust