Cross-sectoral Rehabilitation After Stroke (CRES)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 117
- 试验地点
- 1
- 主要终点
- Change in physical function (30 second chair stand test)
研究概览
简要总结
Prospective cohort study during post stroke rehabilitation in hospital and municipality. Participants will be measured with accelerometers, tests in relation to physical function and qualitative interviews.
详细描述
During and after hospitalization, patients with stroke are subjected to early rehabilitation starting at the hospital stay and continuing after discharge to a municipality. However, the continuity and adherence across sectors is challenged by different locations for the rehabilitation and time gaps from discharge to start in municipality.
This project focuses on the physical activity of patients with stroke measured with 3D accelerometry, the physical performance of the patients measured using the 30 second Chair Stand Test, balance measured with Bergs Balance Scale and health-related quality of life (HRQoL) measured with the 5-level version of European Quality of Life (EQ5D-5L). Furthermore, the patient perspectives and experiences with the rehabilitation plans are explored in semi-structured interviews at the end of the project.
The municipalities in Nordsjælland have been informed regarding the project and all their approvals have been collected prior to expected start in fall 2022. The heads of rehabilitation in the municipalities have approved participation in the research project with regards to follow-up of patients. The municipalities will support the data collection process with a therapist from each municipality working with quality control of the rehabilitation.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age;
- •Hospitalized at Nordsjællands Hospital (NOH) with acute stroke;
- •Discharged from the Department of Neurology NOH with a general rehabilitation plan to one of the eight surrounding municipalities (Hillerød, Allerød, Gribskov, Helsingør, Hørsholm, Halsnæs, Frederikssund Fredensborg);
- •able to give written informed consent;
排除标准
- •Poor Danish language skill;
- •Patients refusing any rehabilitation or medically assessed as inevitably dying within 12 weeks;
结局指标
主要结局
Change in physical function (30 second chair stand test)
时间窗: At four timepoints during rehabilitation. Anticipated days for testing: day 1, day 4, day 11, day 95
Tests performed during in hospital stay and at discharge and at start/end of rehabilitation
Change in balance (Bergs Balance Scale)
时间窗: At four timepoints during rehabilitation. Anticipated days for testing: day 1, day 4, day 11, day 95
Tests performed during in hospital stay and at discharge and at start/end of rehabilitation in municipality. Scores registered in ordinal scale from 0-56 with higher scores indicating lower risk of fall. Bergs Balance Scale consists of 14 test items each with scores ranging from 0, 1, 2, 3 and 4.
Change in Health Related Quality of Life (EQ5D-5L)
时间窗: Measurement at the start of rehabilitation (day 1) and at the anticipated end of rehabilitation (day 95)
Measurements with EQ5D-5L send electronically to participants with REDcap system
Physical activity measured by step counts and intensity minutes during the day (raw acceleration per time cycle)
时间窗: 10-14 days from hospital discharge til start of rehabilitation in municipality
3D Accelerometers able to capture the daily physical activity performed by the participants in terms of intensity minutes and daily step counts (physiological parameter)
次要结局
- Severity of stroke (Scandinavian Stroke Scale)(within 24 hours of admission)
- Rate of dependence post stroke evaluated by modified Rankin Scale (mRS)(Measurement at the discharge from hospital stay (anticipated day 4))
- Demographic variables(Measurement at the start of rehabilitation (anticipated day 1 of hospital admission))
研究者
Gabriel Tafdrup Notkin
Principal Investigator
Nordsjaellands Hospital