Stroke Rehabilitation Outcome During COVID-19 Lockdown (SROCL)

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.

Study Overview

• Status: Completed
• Conditions: Stroke; COVID-19; Rehabilitation; Cohort Studies
• Intervention / Treatment: Behavioral: Observation

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.

• Study Type: Observational
• Enrollment (Actual): 36

Contacts and Locations

Study Locations

• Switzerland
  • Zurich, Switzerland, 8091
    • University Hospital Zurich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Stroke patients

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Single-group study; 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; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Jeremia Held
• Investigators: Study Chair: Andreas R Luft, Prof, University of Zurich

Study record dates

Study Major Dates

• Study Start (Actual): April 16, 2020
• Primary Completion (Actual): October 12, 2020
• Study Completion (Actual): October 12, 2020

Study Registration Dates

• First Submitted: April 16, 2020
• First Submitted That Met QC Criteria: April 30, 2020
• First Posted (Actual): May 4, 2020

Study Record Updates

• Last Update Posted (Actual): October 20, 2020
• Last Update Submitted That Met QC Criteria: October 19, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Stroke; COVID-19
• Other Study ID Numbers: BASEC-Nr. 2020-00761

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No