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Active, Not Recruiting

NCT Number: NCT05566782

Cross-sectoral Rehabilitation After Stroke (CRES)

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Primary outcomes

  1. 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)

  2. 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

  3. 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.

  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

Secondary outcomes

  1. Severity of stroke (Scandinavian Stroke Scale)

    Time frame: 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

  2. Rate of dependence post stroke evaluated by modified Rankin Scale (mRS)

    Time frame: 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.

  3. Demographic variables

    Time frame: Measurement at the start of rehabilitation (anticipated day 1 of hospital admission)

    age, gender, body mass index, marital status, level of education, employment

Sponsors and collaborators

Lead sponsor

Nordsjaellands Hospital

Other

Registry information

Acronym: CRES

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Oct 4, 2022
Registry last updated
Nov 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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