Cross-sectoral Rehabilitation After Stroke (CRES)

NCT05566782 | Active Not Recruiting DMC

• 1 other identifier: CRES&SENS
• Study Type: observational
• Target: 117
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Neurological Rehabilitation; Patient Involvement

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• 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 Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: gender identity is based on medical records and personal identification number
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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;

You may not qualify if:

• Poor Danish language skill;
• Patients refusing any rehabilitation or medically assessed as inevitably dying within 12 weeks;

Sponsors & Collaborators

• Nordsjaellands Hospital: lead

Study Sites (1)

Nordsjællands Hospital Department of Neurology

Hillerød, 3400, Denmark

Location

MeSH Terms

Conditions

Stroke; Patient Participation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Gabriel T Notkin, MSc.PT.

  Physiotherapist, Department of Neurology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 26, 2022
• First Posted: October 4, 2022
• Study Start: January 23, 2022
• Primary Completion: October 5, 2025
• Study Completion: December 1, 2025
• Last Updated: November 15, 2024

Record last verified: 2024-11

Locations

DK (1)