Cross-sectoral Rehabilitation After Stroke (CRES)

Active, not recruiting

• Conditions: Patient Involvement; Stroke; Neurological Rehabilitation

• Registration Number: NCT05566782
• Lead Sponsor: Nordsjaellands Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2022-01-23
• Study First Submitted: 2022-09-26
• Study First Submitted QC: 2022-09-30
• Study First Posted: 2022-10-04
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-13
• Last Update Posted: 2024-11-15
• Primary Completion: 2025-10-05
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 117

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;

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in physical function (30 second chair stand test)	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)	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)	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)	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)

Secondary Outcome Measures

Name	Time	Method
Severity of stroke (Scandinavian Stroke Scale)	within 24 hours of admission	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
Rate of dependence post stroke evaluated by modified Rankin Scale (mRS)	Measurement at the discharge from hospital stay (anticipated day 4)	Evaluation performed by primary investigator with participant. Scores in ordinal scale ranging from 0-6 with higher scores indicating worse outcomes post stroke.
Demographic variables	Measurement at the start of rehabilitation (anticipated day 1 of hospital admission)	age, gender, body mass index, marital status, level of education, employment

Trial Locations

Locations (1)

Nordsjællands Hospital Department of Neurology; 🇩🇰 Hillerod, Denmark