Cross-sectoral Rehabilitation After Stroke (CRES) (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.

Study Overview

• Status: Active, not recruiting
• Conditions: Stroke; Neurological Rehabilitation; Patient Involvement

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 Type: Observational
• Enrollment (Estimated): 117

Contacts and Locations

Study Locations

• Denmark
  • Hillerod, Denmark, 3400
    • Nordsjællands Hospital Department of Neurology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited by the PhD-student Gabriel Tafdrup Notkin (GTN) in collaboration with the Department of Neurology. Potential participants will be approached during admission at the Department of Neurology, NOH.

Potential participants will be informed about the study orally and in writing. Patients will be informed that participation is voluntary and that they can withdraw from the study at any time. There will be an opportunity for reflection time and for the patient to discuss the decision to participate with relatives or caregivers. If the patient wishes to participate in the study, written consent will be obtained in the form of a completed consent form from the patient and relatives.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
CRES-participants; 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?

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)

Collaborators and Investigators

• Sponsor: Nordsjaellands Hospital
• Investigators: Principal Investigator: Gabriel T Notkin, MSc.PT., Physiotherapist, Department of Neurology

Study record dates

Study Major Dates

• Study Start (Actual): January 23, 2022
• Primary Completion (Estimated): October 5, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: September 26, 2022
• First Submitted That Met QC Criteria: September 30, 2022
• First Posted (Actual): October 4, 2022

Study Record Updates

• Last Update Posted (Actual): November 15, 2024
• Last Update Submitted That Met QC Criteria: November 13, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke
• Other Study ID Numbers: CRES&SENS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No