Stroke, IschemicNeuroAdaptNCT04704635
Trajectories of Post-stroke Multidimensional Health
An observational study of Stroke, Ischemic and Transient Ischemic Attack, run by University Medicine Greifswald at 1 site in Germany.
Trial summary
Stroke is thought to cause disability immediately after stroke followed by a 3-to-6-month recovery period, after which disability levels are supposed to stabilize unless recurrent events occur. However, studies showed that post-stroke recovery is heterogeneous. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Stroke, Ischemic, Transient Ischemic Attack, Adaptation, Psychological
- How many people
- 330 participants
- Where
- 1 siteGermany
- Study dates
- 12 May 2021to 18 Sep 2023
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients with acute ischemic stroke/transient ischemic attack (TIA) are enrolled during their acute treatment (1-5 days post-acute ischemic stroke/TIA). Patients with an ABCD2 score ≤ 2 are excluded to reduce the chance of inclusion of patients with TIA mimic. The number of TIA patients is limited to 20% of the sample to avoid a bias towards TIA and to represent common incidents of acute ischemic stroke.
Who may be able to join
- Age ≥ 50 years
- Acute ischemic stroke/high-risk transient ischemic attack (TIA; ABCD2 score ≥ 3)
- Language: Fluent in German
- Written informed consent of patient or caregiver
Who cannot join
- Low-risk TIA (ABCD2 score ≤ 2)
- Severe cognitive impairment (i.e., incomplete orientation)
- Severe communication disorder
- Index event > 5 days prior to enrolment
- Life expectancy < 1 year
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Relationship Between Trajectories of Post-stroke Disability and Self-rated Health
Stroke is thought to cause disability immediately after stroke followed by a 3-to-6-month recovery period, after which disability levels are supposed to stabilize unless recurrent events occur. However, studies showed that post-stroke recovery is heterogeneous. While some stroke survivors quickly recover, others may show an accelerated accumulation of disability over time. The current prospective observational study will investigate trajectories of multidimensional functioning and self-rated health in the year after stroke. Particularly, the study aims to explore the relationship between trajectories of disability and self-rated health. Moreover, the study will focus on potential predictors of changes in disability and self-rated health, i.e., views on aging and psychological resilience. Patients will be recruited during their stay at the stroke unit and participate in a face-to-face interview and four follow-up telephone interviews in the post-stroke year.
Read the detailed description
Ischemic strokes have shown to have long-term impact on functional health apart from their acute effects on neurological functioning. Stroke survivors may experience long-term physical disability, psychopathological symptoms and cognitive decline. Even though these potential consequences are well studied, knowledge on post-stroke trajectories of multidimensional functional health according to the Word Health Organization's (WHO) International Classification of Functioning, Disability and Health (ICF) and their predictors is rare. Particularly, there is a lack of studies investigating the trajectories of self-rated health and different indicators of functional health in the year post-stroke. Therefore, the current study aims to explore trajectories of disability and self-rated health in the year post-stroke, and is the first to analyze the relationship between these trajectories. Thereby, the study addresses the research question whether changes in disability can be predicted by prior self-rated health or changes of self-rated health, and vice versa. Moreover, the study examines the correspondence between changes of disability and self-rated health in the year post-stroke. Additionally, views on aging and psychological resilience, which are relevant to coping processes, are studied as predictors of changes in disability and self-rated health. Patients recruited during their stay at the stroke unit will participate in one face-to-face interview in hospital and four telephone follow-up interviews at 6 weeks, 3 months, 6 months and 12 months post-stroke. Moreover, physical functioning will be externally assessed during their hospital stay. To increase the knowledge on post-stroke trajectories of multidimensional health is of major importance to identify patients at risk for accelerated accumulation of disability. Findings from the current study may contribute to the improvement of post-stroke rehabilitation and secondary prevention.
- Conditions
- Stroke, Ischemic, Transient Ischemic Attack, Adaptation, Psychological, Mental Health Impairment, Adjustment, Self-Rated Health
- Keywords
- Old Age, Mental Health, Psychological Health, Self-Rated Health, Quality of Life, Views on Aging, Resilience, Salutogenesis
- Medical subject headings
- Ischemic Stroke, Ischemic Attack, Transient, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Ischemic stroke/TIA | Patients with ischemic stroke or transient ischemic attack |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Modified Rankin Scale (self-reported)
Degree of disability and dependency
Measured: 1-5 days post-stroke, 6 weeks post-stroke, 3 months post-stroke, 6 months post-stroke, 12 months post-stroke
Change of self-rated health
1-Item assessment of self-rated health
Measured: 1-5 days post-stroke, 6 weeks post-stroke, 3 months post-stroke, 6 months post-stroke, 12 months post-stroke
Secondary outcomes (10)
Change of Barthel Index (self-reported)
Measure of performance in activities of daily living
Measured: 1-5 days post-stroke, 6 weeks post-stroke, 3 months post-stroke, 6 months post-stroke, 12 months post-stroke
Change of Impact of Stroke Scale 16
Assessment of the impact of stroke on four domains (i.e., strength, hand function, mobility, and activities of daily living)
Measured: 1-5 days post-stroke, 6 weeks post-stroke, 3 months post-stroke, 6 months post-stroke, 12 months post-stroke
Change of European Health Interview Survey Physical Activity Questionnaire
Assessment of physical activity
Measured: 1-5 days post-stroke, 6 weeks post-stroke, 3 months post-stroke, 6 months post-stroke, 12 months post-stroke
Change of European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L)
Assessment of quality of life
Measured: 1-5 days post-stroke, 6 weeks post-stroke, 3 months post-stroke, 6 months post-stroke, 12 months post-stroke
Change of IMET (Index for the Assessment of Participation Restrictions)
Assessment of restrictions of participation (according to the WHO concept)
Measured: 1-5 days post-stroke, 6 weeks post-stroke, 3 months post-stroke, 6 months post-stroke, 12 months post-stroke
Change of Fatigue Severity Scale
Assessment of fatigue
Measured: 1-5 days post-stroke, 6 weeks post-stroke, 3 months post-stroke, 6 months post-stroke, 12 months post-stroke
Change of Patient Health Questionnaire-8
Assessment of depressive symptoms
Measured: 1-5 days post-stroke, 6 weeks post-stroke, 3 months post-stroke, 6 months post-stroke, 12 months post-stroke
Change of Pittsburgh Sleep Quality Index (assessment in case of sufficient capacities)
Assessment of sleep quality (3 items)
Measured: 1-5 days post-stroke, 6 weeks post-stroke, 3 months post-stroke, 6 months post-stroke, 12 months post-stroke
Change of Post-Traumatic Stress Syndrome 14 (assessment in case of sufficient capacities)
Assessment of posttraumatic stress symptoms
Measured: 6 weeks post-stroke, 3 months post-stroke, 6 months post-stroke, 12 months post-stroke
Change of Questions on Falling
5 items on falls and fear of falling
Measured: 1-5 days post-stroke, 6 weeks post-stroke, 3 months post-stroke, 6 months post-stroke, 12 months post-stroke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2021
- Study start12 May 2021
- Primary completion30 Aug 2022
- Study completion18 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stroke, IschemicStudies 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
- 330 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medicine Greifswald
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Susanne Wurm, University Medicine Greifswald
- Investigators
- Agnes Flöel, PhD, Principal investigator, University Medicine GreifswaldRobert Fleischmann, PhD, Principal investigator, University Medicine GreifswaldBettina von Sarnowski, PhD, Principal investigator, University Medicine Greifswald
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04704635
- Sponsor's protocol ID
- NeuroAdapt
- Acronym
- NeuroAdapt
- Status last verified
- Nov 2023
- First submitted
- 8 Jan 2021
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Schafer SK, Fleischmann R, von Sarnowski B, Blasing D, Floel A, Wurm S. Relationship between trajectories of post-stroke disability and self-rated health (NeuroAdapt): protocol for a prospective observational study. BMJ Open. 2021 Jun 29;11(6):e049944. doi: 10.1136/bmjopen-2021-049944.
PubMed 34187831
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Trajectories of Post-stroke Disability and Self-rated Health
- ClinicalTrials.gov ID
- NCT04704635
- Acronym / sponsor ID
- NeuroAdapt / NeuroAdapt
- Conditions
- Stroke, Ischemic, Transient Ischemic Attack, Adaptation, Psychological, Mental Health Impairment, Adjustment, Self-Rated Health
- Keywords
- Old Age, Mental Health, Psychological Health, Self-Rated Health, Quality of Life, Views on Aging, Resilience, Salutogenesis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 330 participants (actual)
- Lead sponsor
- University Medicine GreifswaldUniversity, hospital or other
- Study start
- 12 May 2021 (actual)
- Primary completion
- 30 Aug 2022 (actual)
- Study completion
- 18 Sep 2023 (actual)
- First posted
- 11 Jan 2021 (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.
Stroke is thought to cause disability immediately after stroke followed by a 3-to-6-month recovery period, after which disability levels are supposed to stabilize unless recurrent events occur. However, studies showed that post-stroke recovery is heterogeneous. While some stroke survivors quickly recover, others may show an accelerated accumulation of disability over time. The current prospective observational study will investigate trajectories of multidimensional functioning and self-rated health in the year after stroke. Particularly, the study aims to explore the relationship between trajectories of disability and self-rated health. Moreover, the study will focus on potential predictors of changes in disability and self-rated health, i.e., views on aging and psychological resilience. Patients will be recruited during their stay at the stroke unit and participate in a face-to-face interview and four follow-up telephone interviews in the post-stroke year.
Detailed description
Ischemic strokes have shown to have long-term impact on functional health apart from their acute effects on neurological functioning. Stroke survivors may experience long-term physical disability, psychopathological symptoms and cognitive decline. Even though these potential consequences are well studied, knowledge on post-stroke trajectories of multidimensional functional health according to the Word Health Organization's (WHO) International Classification of Functioning, Disability and Health (ICF) and their predictors is rare. Particularly, there is a lack of studies investigating the trajectories of self-rated health and different indicators of functional health in the year post-stroke. Therefore, the current study aims to explore trajectories of disability and self-rated health in the year post-stroke, and is the first to analyze the relationship between these trajectories. Thereby, the study addresses the research question whether changes in disability can be predicted by prior self-rated health or changes of self-rated health, and vice versa. Moreover, the study examines the correspondence between changes of disability and self-rated health in the year post-stroke. Additionally, views on aging and psychological resilience, which are relevant to coping processes, are studied as predictors of changes in disability and self-rated health. Patients recruited during their stay at the stroke unit will participate in one face-to-face interview in hospital and four telephone follow-up interviews at 6 weeks, 3 months, 6 months and 12 months post-stroke. Moreover, physical functioning will be externally assessed during their hospital stay. To increase the knowledge on post-stroke trajectories of multidimensional health is of major importance to identify patients at risk for accelerated accumulation of disability. Findings from the current study may contribute to the improvement of post-stroke rehabilitation and secondary prevention.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ischemic stroke/TIA | – | –Patients with ischemic stroke or transient ischemic attack |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients with acute ischemic stroke/transient ischemic attack (TIA) are enrolled during their acute treatment (1-5 days post-acute ischemic stroke/TIA). Patients with an ABCD2 score ≤ 2 are excluded to reduce the chance of inclusion of patients with TIA mimic. The number of TIA patients is limited to 20% of the sample to avoid a bias towards TIA and to represent common incidents of acute ischemic stroke.
Key inclusion criteria (4 listed)
- Age ≥ 50 years
- Acute ischemic stroke/high-risk transient ischemic attack (TIA; ABCD2 score ≥ 3)
- Language: Fluent in German
- Written informed consent of patient or caregiver
Key exclusion criteria (5 listed)
- Low-risk TIA (ABCD2 score ≤ 2)
- Severe cognitive impairment (i.e., incomplete orientation)
- Severe communication disorder
- Index event > 5 days prior to enrolment
- Life expectancy < 1 year
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change of Modified Rankin Scale (self-reported)
Time frame: 1-5 days post-stroke, 6 weeks post-stroke, 3 months post-stroke, 6 months post-stroke, 12 months post-stroke
Degree of disability and dependency
Change of self-rated health
Time frame: 1-5 days post-stroke, 6 weeks post-stroke, 3 months post-stroke, 6 months post-stroke, 12 months post-stroke
1-Item assessment of self-rated health
10 secondary outcomes
Change of Barthel Index (self-reported)
Time frame: 1-5 days post-stroke, 6 weeks post-stroke, 3 months post-stroke, 6 months post-stroke, 12 months post-stroke
Change of Impact of Stroke Scale 16
Time frame: 1-5 days post-stroke, 6 weeks post-stroke, 3 months post-stroke, 6 months post-stroke, 12 months post-stroke
Change of European Health Interview Survey Physical Activity Questionnaire
Time frame: 1-5 days post-stroke, 6 weeks post-stroke, 3 months post-stroke, 6 months post-stroke, 12 months post-stroke
Change of European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L)
Time frame: 1-5 days post-stroke, 6 weeks post-stroke, 3 months post-stroke, 6 months post-stroke, 12 months post-stroke
Change of IMET (Index for the Assessment of Participation Restrictions)
Time frame: 1-5 days post-stroke, 6 weeks post-stroke, 3 months post-stroke, 6 months post-stroke, 12 months post-stroke
Change of Fatigue Severity Scale
Time frame: 1-5 days post-stroke, 6 weeks post-stroke, 3 months post-stroke, 6 months post-stroke, 12 months post-stroke
Change of Patient Health Questionnaire-8
Time frame: 1-5 days post-stroke, 6 weeks post-stroke, 3 months post-stroke, 6 months post-stroke, 12 months post-stroke
Change of Pittsburgh Sleep Quality Index (assessment in case of sufficient capacities)
Time frame: 1-5 days post-stroke, 6 weeks post-stroke, 3 months post-stroke, 6 months post-stroke, 12 months post-stroke
Change of Post-Traumatic Stress Syndrome 14 (assessment in case of sufficient capacities)
Time frame: 6 weeks post-stroke, 3 months post-stroke, 6 months post-stroke, 12 months post-stroke
Change of Questions on Falling
Time frame: 1-5 days post-stroke, 6 weeks post-stroke, 3 months post-stroke, 6 months post-stroke, 12 months post-stroke
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 29 Nov 2023.
- Derived from this study: PubMed 34187831Schafer SK, Fleischmann R, von Sarnowski B, Blasing D, Floel A, Wurm S. Relationship between trajectories of post-stroke disability and self-rated health (NeuroAdapt): protocol for a prospective observational study. BMJ Open. 2021 Jun 29;11(6):e049944. doi: 10.1136/bmjopen-2021-049944.
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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.
Agnes Flöel, PhD principal investigator
University Medicine Greifswald
Robert Fleischmann, PhD principal investigator
University Medicine Greifswald
Bettina von Sarnowski, PhD principal investigator
University Medicine Greifswald
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, Ischemic and Transient Ischemic Attack, run by University Medicine Greifswald at 1 site in Germany.
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 5 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 29 Nov 2023. 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 Germany. 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?
Change of Modified Rankin Scale (self-reported) (time frame: 1-5 days post-stroke, 6 weeks post-stroke, 3 months post-stroke, 6 months post-stroke, 12 months post-stroke). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04704635, which also lists 1 linked publication.
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 29 Nov 2023; AzTrials last refreshed its copy on 26 Oct 2026.