Cross-sectoral Rehabilitation After Stroke (CRES)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Cross-sectoral Rehabilitation After Stroke (CRES)

Conditions
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Stroke, Neurological Rehabilitation, Patient Involvement

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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; Exclusion Criteria: Poor Danish language skill; Patients refusing any rehabilitation or medically assessed as inevitably dying within 12 weeks;

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CRES-participants<br>The participants in this cohort will start rehabilitation during their inhospital stay and continue the rehabilitation course during discharge to municipality. The rehabilitation will consist of physical exercise and measurements in relation to accelerometry, physical function and qualitative interviews regarding goal for rehabilitation. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical activity measured by step counts and intensity minutes during the day (raw acceleration per time cycle) | 3D Accelerometers able to capture the daily physical activity performed by the participants in terms of intensity minutes and daily step counts (physiological parameter) | 10-14 days from hospital discharge til start of rehabilitation in municipality | 
| Change in physical function (30 second chair stand test) | Tests performed during in hospital stay and at discharge and at start/end of rehabilitation | At four timepoints during rehabilitation. Anticipated days for testing: day 1, day 4, day 11, day 95 | 
| Change in balance (Bergs Balance Scale) | 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. | At four timepoints during rehabilitation. Anticipated days for testing: day 1, day 4, day 11, day 95 | 
| Change in Health Related Quality of Life (EQ5D-5L) | Measurements with EQ5D-5L send electronically to participants with REDcap system | Measurement at the start of rehabilitation (day 1) and at the anticipated end of rehabilitation (day 95) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of stroke (Scandinavian Stroke Scale) | Registration from participants medical records. Scores reported in ordinal scale from 0-58 with higher scores indicating less severe impairment form stroke. Overall categories; mild: 43-58 moderate: 26-42 severe: 0-25 | within 24 hours of admission | 
| Rate of dependence post stroke evaluated by modified Rankin Scale (mRS) | Evaluation performed by primary investigator with participant. Scores in ordinal scale ranging from 0-6 with higher scores indicating worse outcomes post stroke. | Measurement at the discharge from hospital stay (anticipated day 4) | 
| Demographic variables | age, gender, body mass index, marital status, level of education, employment | Measurement at the start of rehabilitation (anticipated day 1 of hospital admission) |