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Clinical Trials/NCT05566782
NCT05566782
Active, not recruiting
Not Applicable

Cross-sectoral Rehabilitation After Stroke (CRES)

Nordsjaellands Hospital1 site in 1 country117 target enrollmentJanuary 23, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
Nordsjaellands Hospital
Enrollment
117
Locations
1
Primary Endpoint
Change in physical function (30 second chair stand test)
Status
Active, not recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 23, 2022
End Date
December 2025
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Nordsjaellands Hospital
Responsible Party
Principal Investigator
Principal Investigator

Gabriel Tafdrup Notkin

Principal Investigator

Nordsjaellands Hospital

Eligibility Criteria

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;

Outcomes

Primary Outcomes

Change in physical function (30 second chair stand test)

Time Frame: 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)

Time Frame: 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)

Time Frame: 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)

Time Frame: 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 Outcomes

  • 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))

Study Sites (1)

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