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Stroke Rehabilitation Outcome During COVID-19 Lockdown

Stroke Rehabilitation Outcome During COVID-19 Lockdown

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04373109
Acronym
SROCL
Enrollment
36
Registered
2020-05-04
Start date
2020-04-16
Completion date
2020-10-12
Last updated
2020-10-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cohort Studies, COVID-19, Rehabilitation, Stroke

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.

Interventions

BEHAVIORALObservation

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

Sponsors

Jeremia Held
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Rehabilitation data3 month after start lockdownNature of rehabilitation therapy, and number and duration of rehabilitation therapy sessions
Motor Activity Log - 14 Item Version3 month after start lockdownPatient-reported upper limb use in daily life
International Physical Activity Questionnaire3 month after start lockdownPatient-reported engagement in physical activity in daily life
Patient-Reported Outcomes Measurement Information System - 29 Version3 month after start lockdownPatient-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

Secondary

MeasureTime frameDescription
Functional Ambulation Categories4 weeks after lockdown (extraordinary situation as defined by the Swiss law), 3 months after lockdown, 6 months after lockdownClassification regarding the ability to walk independently, with or without a walking aid and takes the type of walking surface into account
Ten-Meter Walk Test4 weeks after lockdown (extraordinary situation as defined by the Swiss law), 3 months after lockdown, 6 months after lockdownGait speed and cadence
Rivermead Mobility Index4 weeks after lockdown (extraordinary situation as defined by the Swiss law), 3 months after lockdown, 6 months after lockdownMeasures 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
Activities-specific Balance Confidence Scale4 weeks after lockdown (extraordinary situation as defined by the Swiss law), 3 months after lockdown, 6 months after lockdownSelf-reported measure in which patients rate how confident they are in maintaining balance when performing 16 daily life tasks
Fugl-Meyer Motor Assessment4 weeks after lockdown (extraordinary situation as defined by the Swiss law), 3 months after lockdown, 6 months after lockdownUpper and lower limb motor function
Action Research Arm Test4 weeks after lockdown (extraordinary situation as defined by the Swiss law), 3 months after lockdown, 6 months after lockdownUpper limb capacity
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 lockdownPatient-reported global rating of physical activity engagement and upper limb use in daily life
National Institutes of Health Stroke Scale4 weeks after lockdown (extraordinary situation as defined by the Swiss law), 3 months after lockdown, 6 months after lockdownNeurological impairments
Rehabilitation data4 weeks after lockdown (extraordinary situation as defined by the Swiss law), 6 months after lockdownNature of rehabilitation therapy, and number and duration of rehabilitation therapy sessions
Motor Activity Log - 14 Item Version4 weeks after lockdown (extraordinary situation as defined by the Swiss law), 6 months after lockdownPatient-reported upper limb use in daily life
International Physical Activity Questionnaire4 weeks after lockdown (extraordinary situation as defined by the Swiss law), 6 months after lockdownPatient-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 lockdownPatient-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
modified Rankin Scale4 weeks after lockdown (extraordinary situation as defined by the Swiss law), 3 months after lockdown, 6 months after lockdownGlobal disability
Fatigue Severity Scale4 weeks after lockdown (extraordinary situation as defined by the Swiss law), 3 months after lockdown, 6 months after lockdownSelf-reported questionnaire regarding severity of fatigue and its influence on the performance of daily life activities
Hospital Anxiety and Depression Scale4 weeks after lockdown (extraordinary situation as defined by the Swiss law), 3 months after lockdown, 6 months after lockdownDepression and anxiety
Montreal Cognitive Assessment4 weeks after lockdown (extraordinary situation as defined by the Swiss law), 3 months after lockdown, 6 months after lockdownAssesses cognitive functions

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026