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Cross-sectoral Rehabilitation After Stroke (CRES)

Cross-sectoral Rehabilitation After Stroke (CRES)

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05566782
Acronym
CRES
Enrollment
117
Registered
2022-10-04
Start date
2022-01-23
Completion date
2025-12-31
Last updated
2024-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neurological Rehabilitation, Patient Involvement, Stroke

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.

Interventions

None listed

Sponsors

Nordsjaellands Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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;

Design outcomes

Primary

MeasureTime frameDescription
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 municipality3D Accelerometers able to capture the daily physical activity performed by the participants in terms of intensity minutes and daily step counts (physiological parameter)
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 95Tests 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 95Tests 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

Secondary

MeasureTime frameDescription
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 variablesMeasurement at the start of rehabilitation (anticipated day 1 of hospital admission)age, gender, body mass index, marital status, level of education, employment
Severity of stroke (Scandinavian Stroke Scale)within 24 hours of admissionRegistration 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

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026