Stroke Rehabilitation Outcome During COVID-19 Lockdown

Study Overview
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Brief Summary
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COVID-19 has a big impact on individuals and society as a whole. Especially persons with (multiple) comorbidities such as stroke are affected. The impact of COVID-19 on stroke rehabilitation delivery and stroke patients' functioning is unclear.

Detailed Description
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With 16'000 patients hospitalized and with new permanent disability in approximately 7'000 individuals every year in Switzerland, stroke has a major impact on quality of life and is an enormous socioeconomic burden. Virtually all patients receive inpatient rehabilitation in the sub-acute phase poststroke. However, also in the later phases poststroke, patients receive rehabilitation interventions in outpatient rehabilitation clinics and private practices, with goal to improve or maintain their functional capacity. Currently, Switzerland finds itself in an extraordinary situation. The Federal Council has issued a series of measures aimed at the population, organizations and institutions, and the cantons. The aim is to curb the spread of the coronavirus and assure the provision of healthcare. The people are invoked to stay at home and only leave the home if absolutely necessary. If they are over the age of 65 or have an underlying medical condition, the Federal Council strongly recommend that you stay at home under any circumstances unless you have to go to the doctor. With the recommendation of the Swiss Federal Council almost all stroke patients belong to the group who should stay home. Furthermore, all outpatient rehabilitation clinics have reduced the interventions to a minimum. It is unknown how a sudden stop of rehabilitation influences the stroke patients' functional capacities and their perceived quality of life.

Official Title
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Stroke Rehabilitation Outcome During COVID-19 Lockdown

Conditions
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Stroke, Rehabilitation, COVID-19, Cohort Studies

Intervention / Treatment
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* Behavioral: Observation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ischemic or haemorrhagic stroke, confirmed by MRI-DWI and/or CT Participating in a stroke research project before the Lockdown (ESTREL - BASEC Nr. 2018-02021/ RE-USE - BASEC-Nr. 2017-01070) Age 18 years or older Verbal and written informed consent of the patient after participants' information Exclusion Criteria: Severe communication or cognitive deficits, that cause inability to follow the procedures

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Single-group study<br>Assessment of intensity of rehabilitation therapy, daily life upper limb use, physical activi-ty engagement, patient-reported quality of life, and motor outcome after stroke | Behavioral: Observation<br>* Observation of intensity of rehabilitation therapy, daily life upper limb use, physical activi-ty engagement, patient-reported quality of life, and motor outcome after stroke<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rehabilitation data | Nature of rehabilitation therapy, and number and duration of rehabilitation therapy sessions | 3 month after start lockdown | 
| Motor Activity Log - 14 Item Version | Patient-reported upper limb use in daily life | 3 month after start lockdown | 
| International Physical Activity Questionnaire | Patient-reported engagement in physical activity in daily life | 3 month after start lockdown | 
| Patient-Reported Outcomes Measurement Information System - 29 Version | Patient-self-assessment comprising the following categories: 1) physical function, 2) anxiety, 3) depression, 4) fatigue, 5) sleep disturbance, 6) ability to participate in social roles and activities, 7) pain interference and 8) pain intensity | 3 month after start lockdown | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global Rating of Perceived Changes (physical activity engagement and upper limb use) | Patient-reported global rating of physical activity engagement and upper limb use in daily life | 4 weeks after lockdown (extraordinary situation as defined by the Swiss law), 3 months after lockdown, 6 months after lockdown | 
| Fatigue Severity Scale | Self-reported questionnaire regarding severity of fatigue and its influence on the performance of daily life activities | 4 weeks after lockdown (extraordinary situation as defined by the Swiss law), 3 months after lockdown, 6 months after lockdown | 
| Hospital Anxiety and Depression Scale | Depression and anxiety | 4 weeks after lockdown (extraordinary situation as defined by the Swiss law), 3 months after lockdown, 6 months after lockdown | 
| Montreal Cognitive Assessment | Assesses cognitive functions | 4 weeks after lockdown (extraordinary situation as defined by the Swiss law), 3 months after lockdown, 6 months after lockdown | 
| Functional Ambulation Categories | Classification regarding the ability to walk independently, with or without a walking aid and takes the type of walking surface into account | 4 weeks after lockdown (extraordinary situation as defined by the Swiss law), 3 months after lockdown, 6 months after lockdown | 
| Ten-Meter Walk Test | Gait speed and cadence | 4 weeks after lockdown (extraordinary situation as defined by the Swiss law), 3 months after lockdown, 6 months after lockdown | 
| Rivermead Mobility Index | Measures the ability of patients to make postural adjustments (e.g, move in bed), transfer (e.g. be-tween bed to chair), walk, and use stairs | 4 weeks after lockdown (extraordinary situation as defined by the Swiss law), 3 months after lockdown, 6 months after lockdown | 
| Activities-specific Balance Confidence Scale | Self-reported measure in which patients rate how confident they are in maintaining balance when performing 16 daily life tasks | 4 weeks after lockdown (extraordinary situation as defined by the Swiss law), 3 months after lockdown, 6 months after lockdown | 
| Fugl-Meyer Motor Assessment | Upper and lower limb motor function | 4 weeks after lockdown (extraordinary situation as defined by the Swiss law), 3 months after lockdown, 6 months after lockdown | 
| Action Research Arm Test | Upper limb capacity | 4 weeks after lockdown (extraordinary situation as defined by the Swiss law), 3 months after lockdown, 6 months after lockdown | 
| modified Rankin Scale | Global disability | 4 weeks after lockdown (extraordinary situation as defined by the Swiss law), 3 months after lockdown, 6 months after lockdown | 
| National Institutes of Health Stroke Scale | Neurological impairments | 4 weeks after lockdown (extraordinary situation as defined by the Swiss law), 3 months after lockdown, 6 months after lockdown | 
| Rehabilitation data | Nature of rehabilitation therapy, and number and duration of rehabilitation therapy sessions | 4 weeks after lockdown (extraordinary situation as defined by the Swiss law), 6 months after lockdown | 
| Motor Activity Log - 14 Item Version | Patient-reported upper limb use in daily life | 4 weeks after lockdown (extraordinary situation as defined by the Swiss law), 6 months after lockdown | 
| International Physical Activity Questionnaire | Patient-reported engagement in physical activity in daily life | 4 weeks after lockdown (extraordinary situation as defined by the Swiss law), 6 months after lockdown | 
| Patient-Reported Outcomes Measurement Information System - 29 Version | Patient-self-assessment comprising the following categories: 1) physical function, 2) anxiety, 3) depression, 4) fatigue, 5) sleep disturbance, 6) ability to participate in social roles and activities, 7) pain interference and 8) pain intensity | 4 weeks after lockdown (extraordinary situation as defined by the Swiss law), 6 months after lockdown |