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Stroke Rehabilitation Outcome During COVID-19 Lockdown

Completed
Conditions
Stroke
Cohort Studies
Rehabilitation
COVID-19
Interventions
Behavioral: Observation
Registration Number
NCT04373109
Lead Sponsor
Jeremia Held
Brief Summary

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

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
36
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

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Single-group studyObservationAssessment of intensity of rehabilitation therapy, daily life upper limb use, physical activi-ty engagement, patient-reported quality of life, and motor outcome after stroke
Primary Outcome Measures
NameTimeMethod
Motor Activity Log - 14 Item Version3 month after start lockdown

Patient-reported upper limb use in daily life

Patient-Reported Outcomes Measurement Information System - 29 Version3 month after start lockdown

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

Rehabilitation data3 month after start lockdown

Nature of rehabilitation therapy, and number and duration of rehabilitation therapy sessions

International Physical Activity Questionnaire3 month after start lockdown

Patient-reported engagement in physical activity in daily life

Secondary Outcome Measures
NameTimeMethod
Global Rating of Perceived Changes (physical activity engagement and upper limb use)4 weeks after lockdown ("extraordinary situation" as defined by the Swiss law), 3 months after lockdown, 6 months after lockdown

Patient-reported global rating of physical activity engagement and upper limb use in daily life

Functional Ambulation Categories4 weeks after lockdown ("extraordinary situation" as defined by the Swiss law), 3 months after lockdown, 6 months after lockdown

Classification regarding the ability to walk independently, with or without a walking aid and takes the type of walking surface into account

Action Research Arm Test4 weeks after lockdown ("extraordinary situation" as defined by the Swiss law), 3 months after lockdown, 6 months after lockdown

Upper limb capacity

Motor Activity Log - 14 Item Version4 weeks after lockdown ("extraordinary situation" as defined by the Swiss law), 6 months after lockdown

Patient-reported upper limb use in daily life

Hospital Anxiety and Depression Scale4 weeks after lockdown ("extraordinary situation" as defined by the Swiss law), 3 months after lockdown, 6 months after lockdown

Depression and anxiety

Ten-Meter Walk Test4 weeks after lockdown ("extraordinary situation" as defined by the Swiss law), 3 months after lockdown, 6 months after lockdown

Gait speed and cadence

Fatigue Severity Scale4 weeks after lockdown ("extraordinary situation" as defined by the Swiss law), 3 months after lockdown, 6 months after lockdown

Self-reported questionnaire regarding severity of fatigue and its influence on the performance of daily life activities

Rivermead Mobility Index4 weeks after lockdown ("extraordinary situation" as defined by the Swiss law), 3 months after lockdown, 6 months after lockdown

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

Fugl-Meyer Motor Assessment4 weeks after lockdown ("extraordinary situation" as defined by the Swiss law), 3 months after lockdown, 6 months after lockdown

Upper and lower limb motor function

modified Rankin Scale4 weeks after lockdown ("extraordinary situation" as defined by the Swiss law), 3 months after lockdown, 6 months after lockdown

Global disability

Rehabilitation data4 weeks after lockdown ("extraordinary situation" as defined by the Swiss law), 6 months after lockdown

Nature of rehabilitation therapy, and number and duration of rehabilitation therapy sessions

Montreal Cognitive Assessment4 weeks after lockdown ("extraordinary situation" as defined by the Swiss law), 3 months after lockdown, 6 months after lockdown

Assesses cognitive functions

Activities-specific Balance Confidence Scale4 weeks after lockdown ("extraordinary situation" as defined by the Swiss law), 3 months after lockdown, 6 months after lockdown

Self-reported measure in which patients rate how confident they are in maintaining balance when performing 16 daily life tasks

National Institutes of Health Stroke Scale4 weeks after lockdown ("extraordinary situation" as defined by the Swiss law), 3 months after lockdown, 6 months after lockdown

Neurological impairments

International Physical Activity Questionnaire4 weeks after lockdown ("extraordinary situation" as defined by the Swiss law), 6 months after lockdown

Patient-reported engagement in physical activity in daily life

Patient-Reported Outcomes Measurement Information System - 29 Version4 weeks after lockdown ("extraordinary situation" as defined by the Swiss law), 6 months after lockdown

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

Trial Locations

Locations (1)

University Hospital Zurich

🇨🇭

Zurich, Switzerland

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