Feasibility and Cost Description of Intensive Rehabilitation Involving New Technologies in Patients With Sub-acute Stroke:A Multicenter Single Arm Trial of the Swiss RehabTech Initiative
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 4
- 主要终点
- Correlation Between Scheduled and Performed Trainings
研究概览
简要总结
The objective of the current study is to develop and investigate training concepts involving rehabilitation technology, which aim at exploiting the potential for regaining the ability to perform skilled movements by maximizing training intensity and keeping the motivation of patients high.
The evaluation focuses on feasibility and cost-benefit analyses
详细描述
This feasibility project aims to establish an efficient setting for intensive rehabilitation with new technology in four trailblazer clinics. This will enable them to provide intensive therapy to the patients in accordance with the study protocol. If this setting is integrated into the clinical routine, the investigators will be able to collect data to get some first insight into economic and functional data required to calculate changes in socioeconomic costs
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients with residual hemiparesis after cerebrovascular accident
- •Up to 12 months after the event
- •Primary rehabilitation terminated
- •Able to cognitively comprehend the aim of the project with at least 22 points in the Montreal Cognitive Assessment (MoCA)
- •General health condition allows for intensive rehabilitative training with limited supervision i.e. clearance and prescription of responsible physician
- •Understand written and spoken German language
排除标准
- •Patients with any signs and symptoms showing that the participant is unwilling to participate in the study will result in the patient being excluded from participation Any medical condition preventing participation such as Severe respiratory disease Severe OR unstable cardio-circulatory conditions Orthopaedic conditions, especially in extremities targeted for rehabilitation such as
- •fixed joint contractures limiting range of motion
- •non-consolidated fractures Neuro-psychological conditions including cognitive deficits limiting communication or non-cooperation like (self-) aggressive behaviour Infections or inflammatory diseases, like osteomyelitis
- •Specific absolute contraindication for the training with any of the respective devices:
- •Improper fit of the device, including its harness to relevant extremity(ies)
- •Contraindicated training position (standing, sitting)
- •Device specific contraindications will be respected and will lead to the exclusion of the device for that patient.
研究组 & 干预措施
Technology arm
4 Weeks intervention of intensive rehabilitation using rehabilitation technology, 3-5 h per day, within a 5d week in-or outpatient setting.
干预措施: Rehabilitation technology (Other)
结局指标
主要结局
Correlation Between Scheduled and Performed Trainings
时间窗: 4 weeks
Adherence was operationalized by correlating planned trainings with trainings which were carried out by the participants. Due to the small sample size Spearman's rank correlation was used.
次要结局
- Functional Independence Measurement (FIM) Generic Functional Performance(Baseline and 4 weeks)
- Functional Ambulation Categories (FAC)(Baseline and 4 weeks)
- Box and Block Test(Baseline and 4 weeks)
- Stroke Impact Scale (SIS) Recovery(Baseline and 4 weeks)
- 10m Walk Test= TMT Comfortable(Baseline and 4 weeks)
- Walking Index of the Chedoke-McMaster Stroke Assessment Measure (CMSA)(Baseline and 4 weeks)
- Berg Balance Scale (BBS)(Baseline and 4 weeks)
研究者
Markus Wirz
Head of Physiotherapy R&D
Zurich University of Applied Sciences