Cross-sectoral Rehabilitation After Stroke (CRES)

Stroke Clinical Trial

— CRES  

Official title:

Cross-sectoral Rehabilitation After Stroke (CRES)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05566782
• Other study ID #: CRES&SENS
• Status: Recruiting
• Start date: January 23, 2022
• Est. completion date: December 2025

Study information

• Verified date: March 2023
• Source: Nordsjaellands Hospital
• Contact: Gabriel T Notkin, MSc.PT.
• Phone: +4560703650
• Email: gnot0001[@]regionh.dk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 117
• Est. completion date: December 2025
• Est. primary completion date: October 5, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Neurological Rehabilitation
• Patient Involvement
• Stroke

Locations

Country	Name	City	State
Denmark	Nordsjællands Hospital Department of Neurology	Hillerod

Sponsors (1)

Lead Sponsor	Collaborator
Nordsjaellands Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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)
Secondary	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)