NCT04373109

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 16, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

April 16, 2020

Completed
18 days until next milestone

First Posted

Study publicly available on registry

May 4, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 12, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 12, 2020

Completed
Last Updated

October 20, 2020

Status Verified

October 1, 2020

Enrollment Period

6 months

First QC Date

April 16, 2020

Last Update Submit

October 19, 2020

Conditions

StrokeRehabilitationCOVID-19Cohort Studies

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (16)

  • 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

  • Fatigue Severity Scale

    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

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

  • Montreal Cognitive Assessment

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

  • Functional Ambulation Categories

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

  • +11 more secondary outcomes

Study Arms (1)

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

Interventions

ObservationBEHAVIORAL

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

Single-group study

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Stroke patients

You may qualify if:

  • 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

You may not qualify if:

  • Severe communication or cognitive deficits, that cause inability to follow the procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Zurich

Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

StrokeCOVID-19

Interventions

Observation

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Andreas R Luft, Prof

    University of Zurich

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

April 16, 2020

First Posted

May 4, 2020

Study Start

April 16, 2020

Primary Completion

October 12, 2020

Study Completion

October 12, 2020

Last Updated

October 20, 2020

Record last verified: 2020-10

Locations

CH(1)