Randomised Control Trial for Improving Functional Outcome From Stroke in End Stage Renal Disease Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Upper-Extremity Fugl-Meyer scores
研究概览
简要总结
TITLE Randomised Control Trial (RCT) for improving functional outcome from stroke in renal disease patients DESIGN Eandomised Conrol Study AIMS
- Undertake detailed characterisation of stroke (including recently developed imaging techniques at Imperial) of stroke in renal disease patients including clinical, imaging and epidemiological data
- To Investigate if passive intervention using hand grip device during dialysis sessions will improve functional outcome from stroke in end stage renal disease patients.
OUTCOME MEASURES
- Primary outcome:. 3 months change in Upper-Extremity Fugl-Meyer scores.
- Secondary outcome: 3 months change in NIHS & Bartel scores
POPULATION Ischaemic and haemorrhagic stroke patients with renal disease treated at Hammersmith's Hospital's renal Unit. .
ELIGIBILITY Data of all patients with renal disease and imaging proven stroke will be retrospectively analysed. RCT will be conducted on End Stage Renal Disease patients with acute (<7 days) stroke affecting arm.
DURATION 2 years
详细描述
Randomised Control Trial. ESRD patients on dialysis who have suffered an acute (<7 days) stroke (ischaemic/haemorrhagic) and predicted to have the worst likely outcome (see above) will be recruited for this RCT. Stroke patients will be randomly assigned to the intervention (60 patients) or standard treatment (60 patients) arms (power calculation below). Patients will have detailed demographic information documented. In addition, type, frequency and length of time on dialysis will be noted. Pre-/post- Upper-Extremity Fugl-Meyer scores will be undertaken (sensitive measure of arm motor function).
60 patients will be randomly allocated to the visual-feedback handgrip (affected arm) exercise that we have developed in-house (using Current Designs hand-grip force transducer, and E-Prime software). Subjects allocated to treatment will be trained in the laptop-based exercise that takes 20 minutes/session. Subjects will be encouraged to perform the exercise 2-3 times per dialysis session depending upon mood, although will be permitted to skip sessions if they do not feel well or motivated. The laptop program time-stamps each session, and records a time-series of duration, force and accuracy of hand grip.
Non-intervention. 60 similar ESRD stroke patients will be randomly assigned to the non-intervention arm. These patients will receive standard advice during dialysis (rest or gentle activity, e.g. reading).
Note that both groups of patients will also receive standard multidisciplinary rehabilitation care following a stroke, including therapy sessions at times other than receiving dialysis
3.1 STUDY OUTCOME MEASURES Primary outcome. 3 months change in Upper-Extremity Fugl-Meyer scores. Secondary outcome: 3 months changes in NIHS & Bartel scores
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
- Single (Outcomes Assessor)
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
- •Patients with imaging proven, acute (<7days) stroke affecting arm, on maintenance dialysis will be recruited into the RCT. Patients have to be able to consent for the study either in writing, verbally or nonverbally in presence of a witness. We will retrospectively analyse the database of all renal disease patients with stroke. This data was collected by Hammersmith Hospital's Renal Team. In case of non-English speaking patients we will use Hospital's interpreter's services to explain the study to the patient, obtain their consent and train them in using the device
排除标准
- •Patients unwilling to give consent, patients unable to use hand grip tool due to severe hand weakness (MRC 0/5), patients unable to understand English or their native language due to receptive aphasia, dementia. Patients with arteriovenous fistula in the affected arm will be excluded from the trial
研究组 & 干预措施
visual-feedback handgrip exercise
Subjects allocated to treatment will be trained in the laptop-based exercise that takes 20 minutes/session. Subjects will be encouraged to perform the exercise 2-3 times per dialysis session
干预措施: Computer-based target pursuit task (created using E-Prime software) and visual-feedback handgrip force transducer (CurrentDesigns 2012). (Device)
Control Arm
60 similar ESRD stroke patients will be randomly assigned to the non-intervention arm. These patients will receive standard advice during dialysis (rest or gentle activity, e.g. reading).
Note that both groups of patients will also receive standard multidisciplinary rehabilitation care following a stroke, including therapy sessions at times other than receiving dialysis
结局指标
主要结局
Upper-Extremity Fugl-Meyer scores
时间窗: 3 months
sensitive measure of arm motor function
次要结局
未报告次要终点