Clinical trial NCT04373109: Stroke Rehabilitation Outcome During COVID-19 Lockdown
Official title: Stroke Rehabilitation Outcome During COVID-19 Lockdown
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Rehabilitation
COVID-19
Cohort Studies
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2020-05-04
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Stroke patients

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.

Eligibility criteria: 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

Primary outcomes:
measure: Rehabilitation data
timeFrame: 3 month after start lockdown
measure: Motor Activity Log - 14 Item Version
timeFrame: 3 month after start lockdown
measure: International Physical Activity Questionnaire
timeFrame: 3 month after start lockdown
measure: Patient-Reported Outcomes Measurement Information System - 29 Version
timeFrame: 3 month after start lockdown
Secondary outcomes:
measure: Global Rating of Perceived Changes (physical activity engagement and upper limb use)
timeFrame: 4 weeks after lockdown ("extraordinary situation" as defined by the Swiss law), 3 months after lockdown, 6 months after lockdown
measure: Fatigue Severity Scale
timeFrame: 4 weeks after lockdown ("extraordinary situation" as defined by the Swiss law), 3 months after lockdown, 6 months after lockdown
measure: Hospital Anxiety and Depression Scale
timeFrame: 4 weeks after lockdown ("extraordinary situation" as defined by the Swiss law), 3 months after lockdown, 6 months after lockdown
measure: Montreal Cognitive Assessment
timeFrame: 4 weeks after lockdown ("extraordinary situation" as defined by the Swiss law), 3 months after lockdown, 6 months after lockdown
measure: Functional Ambulation Categories
timeFrame: 4 weeks after lockdown ("extraordinary situation" as defined by the Swiss law), 3 months after lockdown, 6 months after lockdown
measure: Ten-Meter Walk Test
timeFrame: 4 weeks after lockdown ("extraordinary situation" as defined by the Swiss law), 3 months after lockdown, 6 months after lockdown
measure: Rivermead Mobility Index
timeFrame: 4 weeks after lockdown ("extraordinary situation" as defined by the Swiss law), 3 months after lockdown, 6 months after lockdown
measure: Activities-specific Balance Confidence Scale
timeFrame: 4 weeks after lockdown ("extraordinary situation" as defined by the Swiss law), 3 months after lockdown, 6 months after lockdown
measure: Fugl-Meyer Motor Assessment
timeFrame: 4 weeks after lockdown ("extraordinary situation" as defined by the Swiss law), 3 months after lockdown, 6 months after lockdown
measure: Action Research Arm Test
timeFrame: 4 weeks after lockdown ("extraordinary situation" as defined by the Swiss law), 3 months after lockdown, 6 months after lockdown
measure: modified Rankin Scale
timeFrame: 4 weeks after lockdown ("extraordinary situation" as defined by the Swiss law), 3 months after lockdown, 6 months after lockdown
measure: National Institutes of Health Stroke Scale
timeFrame: 4 weeks after lockdown ("extraordinary situation" as defined by the Swiss law), 3 months after lockdown, 6 months after lockdown
measure: Rehabilitation data
timeFrame: 4 weeks after lockdown ("extraordinary situation" as defined by the Swiss law), 6 months after lockdown
measure: Motor Activity Log - 14 Item Version
timeFrame: 4 weeks after lockdown ("extraordinary situation" as defined by the Swiss law), 6 months after lockdown
measure: International Physical Activity Questionnaire
timeFrame: 4 weeks after lockdown ("extraordinary situation" as defined by the Swiss law), 6 months after lockdown
measure: Patient-Reported Outcomes Measurement Information System - 29 Version
timeFrame: 4 weeks after lockdown ("extraordinary situation" as defined by the Swiss law), 6 months after lockdown
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich
Study officials:
affiliation: University of Zurich
name: Andreas R Luft, Prof
role: STUDY_CHAIR
References: