Rehabilitation and Clinical Observation of stroke patients to validate prognostic factors of functional and subjective Recovery after Stroke (RECOVER-S): A registry-based cohort study

Recruiting

• Conditions: I63; I61; Cerebral infarction; Intracerebral haemorrhage

• Registration Number: DRKS00030023
• Lead Sponsor: Charité Campus Charité Mitte

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-08-25
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

1. male or female adult:r = 18 years at the time of study inclusion.
2. acute stroke (ischemic or intracerebral hemorrhagic) confirmed by computed tomography (CT) or magnetic resonance imaging (MRI) image morphology
3. inclusion in the study within = 9 days after stroke (inclusion in an acute care hospital) or within = 35 days after stroke (inclusion in a rehabilitation hospital/geriatric ward)
4. neurological or geriatric rehabilitation (outpatient or inpatient) planned or recommended.

Exclusion Criteria

1. no neurological or geriatric rehabilitation (outpatient or inpatient) planned.
2. intracranial hemorrhage primary in the context of a subarachnoid hemorrhage, subdural or epidural hematoma (small, concomitant portions in primary ICB are not an exclusion criterion)
3. post-stroke according to diagnosis list (clinically silent strokes not known or diagnosed prior to stay are not exclusion criteria)
4. invasive long-term ventilation at the time of study inclusion
5.Life expectancy before stroke <12 months.

Biomarker cohort-specific exclusion criteria:
1. patient:ing with a primary hemorrhagic stroke.
2. presence of MRI contraindications (e.g., pacemaker, claustrophobia, metallic implants, etc.)
3. inability (for MRI measurement) to lie still for > 30 minutes.

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
RECOVER-S aims to examine stroke rehabilitation in Germany using a multicentric- and biomarker-based approach to provide a reliable depiction on the standard of care in stroke stroke rehabilitation.<br><br>This registry-based cohort study has the following goals: 1. To evaluate the association between stroke rehabilitation therapies and long-term functional and subjective outcome with regards to timing, intensity, duration, dosing and amount of stroke rehabilitation.<br>Hypothesis to goal 1: There is an interindividual difference in the subjective and functional recovery of stroke patients after 6 months, that depends on the type, timing, intensity, duration, dosing and amount of stroke rehabiliation. This hypothesis will be tested using the following endpoints:<br>Primary Endpoints:<br>1. Activities in daily living (assessed by the Barthel-Index) at six months after stroke<br>2. Health-related quality of life (assessed by the EQ-5D-5L) at six months after stroke<br>

Secondary Outcome Measures

Name	Time	Method
Key Secondary Endpoints:<br>1. Safety (all-cause mortality, combined cardiovascular events (stroke, myocardial infarction), re-hospitalization, frequency and severity of falls)<br>2. Clinical scores (modified Rankin Scale (mRS), National institutes of health stroke scale (NIHSS))<br>3. Functional Scores (e.g., volitional grip movement)<br>4. Quality of aftercare<br>5. Activities in daily living (assessed by the Barthel-Index)at 12 and 24 months after stroke<br>6. Health-related quality of life (assessed by the EQ-5D-5L)at 12 and 24 months after stroke