StrokeSROCLNCT04373109
Stroke Rehabilitation Outcome During COVID-19 Lockdown
An observational study of Stroke and Rehabilitation, run by Jeremia Held at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Rehabilitation, COVID-19
- What is being tested?
- Observation
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 36 participants
- Where
- 1 siteSwitzerland
- Study dates
- 16 Apr 2020to 12 Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Stroke patients
Who may be able to join
- 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
Who cannot join
- Severe communication or cognitive deficits, that cause inability to follow the procedures
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Stroke, Rehabilitation, COVID-19, Cohort Studies
- Being tested
- Observation
- Medical subject headings
- Stroke, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rehabilitation data
Nature of rehabilitation therapy, and number and duration of rehabilitation therapy sessions
Measured: 3 month after start lockdown
Motor Activity Log - 14 Item Version
Patient-reported upper limb use in daily life
Measured: 3 month after start lockdown
International Physical Activity Questionnaire
Patient-reported engagement in physical activity in daily life
Measured: 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
Measured: 3 month after start lockdown
Secondary outcomes (16)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 4 weeks after lockdown ("extraordinary situation" as defined by the Swiss law), 6 months after lockdown
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2020
- Study start16 Apr 2020
- Primary completion12 Oct 2020
- Study completion12 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jeremia Held
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jeremia Held, University of Zurich
- Investigators
- Andreas R Luft, Prof, Study chair, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04373109
- Sponsor's protocol ID
- BASEC-Nr. 2020-00761
- Acronym
- SROCL
- Status last verified
- Oct 2020
- First submitted
- 16 Apr 2020
- Last updated
- 20 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stroke Rehabilitation Outcome During COVID-19 Lockdown
- ClinicalTrials.gov ID
- NCT04373109
- Acronym / sponsor ID
- SROCL / BASEC-Nr. 2020-00761
- Conditions
- Stroke, Rehabilitation, COVID-19, Cohort Studies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Jeremia HeldUniversity, hospital or other
- Study start
- 16 Apr 2020 (actual)
- Primary completion
- 12 Oct 2020 (actual)
- Study completion
- 12 Oct 2020 (actual)
- First posted
- 4 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single-group study | – | Behavioral: ObservationAssessment of intensity of rehabilitation therapy, daily life upper limb use, physical activi-ty engagement, patient-reported quality of life, and motor outcome after stroke |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Stroke patients
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Severe communication or cognitive deficits, that cause inability to follow the procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationObservation of intensity of rehabilitation therapy, daily life upper limb use, physical activi-ty engagement, patient-reported quality of life, and motor outcome after stroke | Behavioural | Single-group study |
Primary outcome
Rehabilitation data
Time frame: 3 month after start lockdown
Nature of rehabilitation therapy, and number and duration of rehabilitation therapy sessions
Motor Activity Log - 14 Item Version
Time frame: 3 month after start lockdown
Patient-reported upper limb use in daily life
International Physical Activity Questionnaire
Time frame: 3 month after start lockdown
Patient-reported engagement in physical activity in daily life
Patient-Reported Outcomes Measurement Information System - 29 Version
Time frame: 3 month after start lockdown
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
16 secondary outcomes
Global Rating of Perceived Changes (physical activity engagement and upper limb use)
Time frame: 4 weeks after lockdown ("extraordinary situation" as defined by the Swiss law), 3 months after lockdown, 6 months after lockdown
Fatigue Severity Scale
Time frame: 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
Time frame: 4 weeks after lockdown ("extraordinary situation" as defined by the Swiss law), 3 months after lockdown, 6 months after lockdown
Montreal Cognitive Assessment
Time frame: 4 weeks after lockdown ("extraordinary situation" as defined by the Swiss law), 3 months after lockdown, 6 months after lockdown
Functional Ambulation Categories
Time frame: 4 weeks after lockdown ("extraordinary situation" as defined by the Swiss law), 3 months after lockdown, 6 months after lockdown
Ten-Meter Walk Test
Time frame: 4 weeks after lockdown ("extraordinary situation" as defined by the Swiss law), 3 months after lockdown, 6 months after lockdown
Rivermead Mobility Index
Time frame: 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
Time frame: 4 weeks after lockdown ("extraordinary situation" as defined by the Swiss law), 3 months after lockdown, 6 months after lockdown
Fugl-Meyer Motor Assessment
Time frame: 4 weeks after lockdown ("extraordinary situation" as defined by the Swiss law), 3 months after lockdown, 6 months after lockdown
Action Research Arm Test
Time frame: 4 weeks after lockdown ("extraordinary situation" as defined by the Swiss law), 3 months after lockdown, 6 months after lockdown
modified Rankin Scale
Time frame: 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
Time frame: 4 weeks after lockdown ("extraordinary situation" as defined by the Swiss law), 3 months after lockdown, 6 months after lockdown
Rehabilitation data
Time frame: 4 weeks after lockdown ("extraordinary situation" as defined by the Swiss law), 6 months after lockdown
Motor Activity Log - 14 Item Version
Time frame: 4 weeks after lockdown ("extraordinary situation" as defined by the Swiss law), 6 months after lockdown
International Physical Activity Questionnaire
Time frame: 4 weeks after lockdown ("extraordinary situation" as defined by the Swiss law), 6 months after lockdown
Patient-Reported Outcomes Measurement Information System - 29 Version
Time frame: 4 weeks after lockdown ("extraordinary situation" as defined by the Swiss law), 6 months after lockdown
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Stroke
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ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
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Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas R Luft, Prof study chair
University of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Rehabilitation, run by Jeremia Held at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rehabilitation data (time frame: 3 month after start lockdown). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2020.