Stroke Rehabilitation Outcome During COVID-19 Lockdown

Stroke Clinical Trial

— SROCL  

Official title:

Stroke Rehabilitation Outcome During COVID-19 Lockdown

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04373109
• Other study ID #: BASEC-Nr. 2020-00761
• Status: Completed
• Start date: April 16, 2020
• Est. completion date: October 12, 2020

Study information

• Verified date: October 2020
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: October 12, 2020
• Est. primary completion date: October 12, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cohort Studies
• COVID-19
• Rehabilitation
• Stroke

Intervention

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

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
Jeremia Held

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rehabilitation data	Nature of rehabilitation therapy, and number and duration of rehabilitation therapy sessions	3 month after start lockdown
Primary	Motor Activity Log - 14 Item Version	Patient-reported upper limb use in daily life	3 month after start lockdown
Primary	International Physical Activity Questionnaire	Patient-reported engagement in physical activity in daily life	3 month after start lockdown
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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