Ischemic StrokeFRAILTYNCT04839887
Factors Affecting the Quality of Life After Ischemic Stroke in Young Adults
An observational study of Ischemic Stroke, run by Elena Gurkova at 1 site in Czechia.
Trial summary
Despite a generally favourable 3-month functional outcome and a very low mortality, young ischemic stroke (IS) patients face to reduced quality of life associated with a complexity of problems or "invisible dysfunctions" after IS. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Ischemic Stroke
- How many people
- 520 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Mar 2021to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 65 years
- All sexes
- Adult, Older adult
Study population: Participants will be recruited from individuals, diagnosed with ischemic stroke according to the ICD-10 classification who will be admitted to the stroke unit.
Who may be able to join
- Acute ischemic stroke
- Age 18-65 years
Who cannot join
- Transient ischemic attack without progression to ischemic stroke
- Haemorrhagic stroke
- Severe cognitive impairment
- Severe communication disorder (sensory aphasia with the inability to understand having been verified by a certified speech therapist)
- Concomitant severe systemic illness
- Impaired ability to understand the questionnaires
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia1 site, 1 recruiting
- Recruiting
Palacky University, Faculty of Health Sciences
Olomouc, 77515
Lenka Satekova, PhD, +420585632821, lenka.satekova@upol.cz
Daniel Sanak, MD, PhD, +420588442836, daniel.sanak@fnol.cz
About this study
Official title: Factors Affecting the Quality of Life After Ischemic Stroke in Young Adults: a Prospective Observational Study in Young Ischemic Stroke Patients Under 50 Years
Despite a generally favourable 3-month functional outcome and a very low mortality, young ischemic stroke (IS) patients face to reduced quality of life associated with a complexity of problems or "invisible dysfunctions" after IS. Better identification and understanding to these factors may improve stroke rehabilitation and stroke self-management programmes, wich will lead to better stroke recovery. The aim of the study is to assess the predictors of the health-related quality of life in young patients under 50 years after ischemic stroke, and to to evaluate specific changes in different dimensions of health-related quality of life during the first year of post-stroke recovery using a standardized battery of neuropsychological tools and stroke specific health-related quality of life measures. In the first phase of the study, 300 IS patients will be enrolled for the validation of the Czech version of the the Stroke Impact Scale 3.0. In the second phase of study, 200 enrolled IS patients (100 young IS patients < 50 years and 100 IS patients of 50-65 years) will undergo a serial of structured and standardized questionnaires during scheduled outpatients' controls three, six and 12 months after IS. In the third phase of study, twenty young IS patients < 50 years will undergo an in-depth, semi-structured interview with explanatory questions that will allow a detailed understanding of the patient's experience. Interpretative phenomenological analysis (IPA) study design will be used.
Read the detailed description
Despite a generally favourable 3-month functional outcome and a very low mortality, young ischemic stroke (IS) patients face to reduced quality of life associated with a complexity of problems or "invisible dysfunctions" after IS. Fatigue, cognitive impairment, anxiety, depression, sexual dysfunction, loss of employment, social isolation, lack of specialist support, reduction in mobility and life roles, negative body image, impaired self-efficacy and self-esteem are considered most relevant factors. Investigation of predictors of post-stroke quality of life in young-onset patients is needed to design, implement, and evaluate specific young stroke rehabilitation and stroke self-management programmes.
The aim of the study is to assess the predictors of the health-related quality of life in young patients under 50 years after ischemic stroke, and to evaluate specific changes in different dimensions of health-related quality of life during the first year of post-stroke recovery using a standardized battery of neuropsychological tools and stroke specific health-related quality of life measures. The aims of the study will be met by the triangulation of qualitative and quantitative research methods.
In the first phase of the study, 300 IS patients will be enrolled for the validation of the Czech version of the the Stroke Impact Scale 3.0. The reliability and validity study will have a cross-sectional design. In the second phase of study, 200 enrolled IS patients (100 young IS patients < 50 years and 100 IS patients of 50-65 years) will undergo a serial of structured and standardized questionnaires during scheduled outpatients' controls three, six and 12 months after IS. In all enrolled patients, the functional outcome, neuropsychological status and quality of life will be assessed using standardized scales and tools. In the third phase of study, twenty young IS patients < 50 years will undergo an in-depth, semi-structured interview with explanatory questions that will allow a detailed understanding of the patient's experience. Interpretative phenomenological analysis (IPA) study design will be used.
- Conditions
- Ischemic Stroke
- Keywords
- Young Ischemic Stroke, Stroke recovery, Health-Related Quality of Life, Life Change Events, Life Experiences
- Medical subject headings
- Ischemic Stroke
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 |
|---|---|---|
| Validation study | Three hundred patients with ischemic stroke (18-65 years) will be enrolled for the validation of the Czech version of the the Stroke Impact Scale 3.0. The reliability and validity study will have a cross-sectional design. | |
| Prospective quantitative study | Two hundred enrolled IS patients (100 young IS patients < 50 years and 100 IS patients of 50-65 years) will undergo a serial of structured and standardized questionnaires during scheduled outpatients' controls three, six and 12 months after IS. In all enrolled patients, the functional outcome, neuropsychological status and quality of life will be assessed using standardized scales and tools. | |
| In-depth interview qualitative study | twenty young IS patients < 50 years will undergo an in-depth, semi-structured interview with explanatory questions that will allow a detailed understanding of the patient's experience. Interpretative phenomenological analysis (IPA) study design will be used. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Stroke Impact Scale (version 3.0)
Assessment of the impact of stroke on eight domains relating to self-rated quality of life, self-perceived disability, and global recovery after stroke (i.e., strength, hand function, mobility, physical and instrumental activities of daily living, memory and thinking, communication, emotion, and social participation). Scores for each domain range from 0 to 100, and higher scores indicate a better health related quality of life
Measured: three, six and 12 months after stroke
Secondary outcomes (7)
Change of the World Health Organization Quality of Life - BREF version (WHOQOL-BREF, self-reported)
Assessment of four domains relating to quality of life (Physical health, Psychological domain, Social relationships, Environment). The four domain scores are scaled in a positive direction with higher scores indicating a higher quality of life. The domain scores will be transformed in accordance with two transformation methods outlined in the WHOQOL-BREF scoring instructions. The domain scores will be transformed into scores ranging between 4 and 20 points (the first transformation method) or into a linear scale between 0 and 100 points (the second transformation method)
Measured: three, six and 12 months after stroke
Change of the Barthel Index of Activities of Daily Living (self-reported)
Measure of performance in activities of daily living. Measure of performance in activities of daily living. Scores of 10 personal activities range from 0 to 100 points and higher score indicates greater independence.
Measured: three, six and 12 months after stroke
Change of Modified Rankin Scale (self-reported)
Scale used for measuring the degree of disability or dependence in the daily activities in patients after stroke. Most widely used clinical outcome measure after stroke. Scale has six points and higher score means worse outcome; minimum is 0 points indicating no symptoms at all and maximum is 6 points indicating death.
Measured: three, six and 12 months after stroke
Change of post-stroke depression and anxiety (self-reported)
Assessment of depressive and anxiety symptoms using Beck Depression Inventory II and Hospital Anxiety and Depression Scale. Higher total scores indicate more severe depressive symptoms.
Measured: three, six and 12 months after stroke
Change of the Montreal Cognitive Assessment (MoCA)
Assessment of cognitive functions (cognitive test measuring specific cognitive domains). The MoCA generates a total score and six domain-specific index scores: Memory, Executive Functioning, Attention, Language, Visuospatial, and Orientation. MoCA score range between 0 and 30. Higher score indicates better cognitive functions. The following ranges are used to grade the severity of cognitive impairment: 18-25 = mild cognitive impairment, 10-17= moderate cognitive impairment and less than 10= severe cognitive impairment.
Measured: three, six and 12 months after stroke
Change from 3-month the lived experience of ischemic stroke of young patients up to 50 years at 12 months.
Semi-structured interviews with stroke patients
Measured: three and 12 months after stroke
Change in the NIH Stroke Scale (NIHSS)
NIHSS is used to objectively quantify the impairment caused by a stroke. Higher score indicates more severe neurological deficit.
Measured: three, six and 12 months after stroke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2021
- Study start1 Mar 2021
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Ischemic 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
- 520 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Elena Gurkova
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Olomouc
- Responsible party
- Sponsor-investigator, Elena Gurkova, Palacky University
- Investigators
- Elena Gurkova, PhD, Principal investigator, Palacky University, Faculty of Health Sciences, Department of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04839887
- Sponsor's protocol ID
- NU21-09-00053
- Acronym
- FRAILTY
- Status last verified
- Apr 2024
- First submitted
- 7 Apr 2021
- Last updated
- 4 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Arntz RM, van Alebeek ME, Synhaeve NE, Brouwers PJ, van Dijk GW, Gons RA, den Heijer T, de Kort PL, de Laat KF, van Norden AG, Vermeer SE, van der Vlugt MJ, Kessels RP, van Dijk EJ, de Leeuw FE. Observational Dutch Young Symptomatic StrokE studY (ODYSSEY): study rationale and protocol of a multicentre prospective cohort study. BMC Neurol. 2014 Mar 22;14:55. doi: 10.1186/1471-2377-14-55.
PubMed 24655479Bartholome L, Winter Y. Quality of Life and Resilience of Patients With Juvenile Stroke: A Systematic Review. J Stroke Cerebrovasc Dis. 2020 Oct;29(10):105129. doi: 10.1016/j.jstrokecerebrovasdis.2020.105129. Epub 2020 Jul 15.
PubMed 32912563Boot E, Ekker MS, Putaala J, Kittner S, De Leeuw FE, Tuladhar AM. Ischaemic stroke in young adults: a global perspective. J Neurol Neurosurg Psychiatry. 2020 Apr;91(4):411-417. doi: 10.1136/jnnp-2019-322424. Epub 2020 Feb 3.
PubMed 32015089de Bruijn MA, Synhaeve NE, van Rijsbergen MW, de Leeuw FE, Mark RE, Jansen BP, de Kort PL. Quality of Life after Young Ischemic Stroke of Mild Severity Is Mainly Influenced by Psychological Factors. J Stroke Cerebrovasc Dis. 2015 Oct;24(10):2183-8. doi: 10.1016/j.jstrokecerebrovasdis.2015.04.040. Epub 2015 Jul 26.
PubMed 26215135Douven E, Schievink SH, Verhey FR, van Oostenbrugge RJ, Aalten P, Staals J, Kohler S. The Cognition and Affect after Stroke - a Prospective Evaluation of Risks (CASPER) study: rationale and design. BMC Neurol. 2016 May 12;16:65. doi: 10.1186/s12883-016-0588-1.
PubMed 27176617Ekker MS, Boot EM, Singhal AB, Tan KS, Debette S, Tuladhar AM, de Leeuw FE. Epidemiology, aetiology, and management of ischaemic stroke in young adults. Lancet Neurol. 2018 Sep;17(9):790-801. doi: 10.1016/S1474-4422(18)30233-3.
PubMed 30129475Harno H, Haapaniemi E, Putaala J, Haanpaa M, Makela JP, Kalso E, Tatlisumak T. Central poststroke pain in young ischemic stroke survivors in the Helsinki Young Stroke Registry. Neurology. 2014 Sep 23;83(13):1147-54. doi: 10.1212/WNL.0000000000000818. Epub 2014 Aug 15.
PubMed 25128182Heiberg G, Friborg O, Pedersen SG, Thrane G, Holm Stabel H, Feldbaek Nielsen J, Anke A. Post-stroke health-related quality of life at 3 and 12 months and predictors of change in a Danish and Arctic Norwegian Region. J Rehabil Med. 2020 Sep 8;52(9):jrm00096. doi: 10.2340/16501977-2716.
PubMed 32735024Kapoor A, Scott C, Lanctot KL, Herrmann N, Murray BJ, Thorpe KE, Lien K, Sicard M, Swartz RH. Symptoms of depression and cognitive impairment in young adults after stroke/transient ischemic attack. Psychiatry Res. 2019 Sep;279:361-363. doi: 10.1016/j.psychres.2019.06.022. Epub 2019 Jul 1.
PubMed 31272664Kono Y, Terasawa Y, Sakai K, Iguchi Y, Nishiyama Y, Nito C, Suda S, Kimura K, Kanzawa T, Imafuku I, Nakayama T, Ueda M, Iwanaga T, Kono T, Yamashiro K, Tanaka R, Okubo S, Nakajima M, Nakajima N, Mishina M, Yaguchi H, Oka H, Suzuki M, Osaki M, Kaneko N, Kitagawa K, Okamoto S, Nomura K, Yamazaki M, Nagao T, Murakami Y. Risk factors, etiology, and outcome of ischemic stroke in young adults: A Japanese multicenter prospective study. J Neurol Sci. 2020 Oct 15;417:117068. doi: 10.1016/j.jns.2020.117068. Epub 2020 Jul 29.
PubMed 32745720Lam KH, Blom E, Kwa VIH. Predictors of quality of life 1 year after minor stroke or TIA: a prospective single-centre cohort study. BMJ Open. 2019 Nov 2;9(11):e029697. doi: 10.1136/bmjopen-2019-029697.
PubMed 31678939Maaijwee NA, Arntz RM, Rutten-Jacobs LC, Schaapsmeerders P, Schoonderwaldt HC, van Dijk EJ, de Leeuw FE. Post-stroke fatigue and its association with poor functional outcome after stroke in young adults. J Neurol Neurosurg Psychiatry. 2015 Oct;86(10):1120-6. doi: 10.1136/jnnp-2014-308784. Epub 2014 Oct 31.
PubMed 25362090McKevitt C, Redfern J, Mold F, Wolfe C. Qualitative studies of stroke: a systematic review. Stroke. 2004 Jun;35(6):1499-505. doi: 10.1161/01.STR.0000127532.64840.36. Epub 2004 Apr 22.
PubMed 15105517Pinter D, Enzinger C, Gattringer T, Eppinger S, Niederkorn K, Horner S, Fandler S, Kneihsl M, Krenn K, Bachmaier G, Fazekas F. Prevalence and short-term changes of cognitive dysfunction in young ischaemic stroke patients. Eur J Neurol. 2019 May;26(5):727-732. doi: 10.1111/ene.13879. Epub 2019 Jan 9.
PubMed 30489673Rhudy LM, Wells-Pittman J, Flemming KD. Psychosocial Sequelae of Stroke in Working-Age Adults: A Pilot Study. J Neurosci Nurs. 2020 Aug;52(4):192-199. doi: 10.1097/JNN.0000000000000523.
PubMed 32511173
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Affecting the Quality of Life After Ischemic Stroke in Young Adults: a Prospective Observational Study in Young Ischemic Stroke Patients Under 50 Years
- ClinicalTrials.gov ID
- NCT04839887
- Acronym / sponsor ID
- FRAILTY / NU21-09-00053
- Conditions
- Ischemic Stroke
- Keywords
- Young Ischemic Stroke, Stroke recovery, Health-Related Quality of Life, Life Change Events, Life Experiences
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 520 participants (estimated)
- Lead sponsor
- Elena GurkovaUniversity, hospital or other
- Collaborators
- University Hospital Olomouc
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 9 Apr 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.
Despite a generally favourable 3-month functional outcome and a very low mortality, young ischemic stroke (IS) patients face to reduced quality of life associated with a complexity of problems or "invisible dysfunctions" after IS. Better identification and understanding to these factors may improve stroke rehabilitation and stroke self-management programmes, wich will lead to better stroke recovery. The aim of the study is to assess the predictors of the health-related quality of life in young patients under 50 years after ischemic stroke, and to to evaluate specific changes in different dimensions of health-related quality of life during the first year of post-stroke recovery using a standardized battery of neuropsychological tools and stroke specific health-related quality of life measures. In the first phase of the study, 300 IS patients will be enrolled for the validation of the Czech version of the the Stroke Impact Scale 3.0. In the second phase of study, 200 enrolled IS patients (100 young IS patients < 50 years and 100 IS patients of 50-65 years) will undergo a serial of structured and standardized questionnaires during scheduled outpatients' controls three, six and 12 months after IS. In the third phase of study, twenty young IS patients < 50 years will undergo an in-depth, semi-structured interview with explanatory questions that will allow a detailed understanding of the patient's experience. Interpretative phenomenological analysis (IPA) study design will be used.
Detailed description
Despite a generally favourable 3-month functional outcome and a very low mortality, young ischemic stroke (IS) patients face to reduced quality of life associated with a complexity of problems or "invisible dysfunctions" after IS. Fatigue, cognitive impairment, anxiety, depression, sexual dysfunction, loss of employment, social isolation, lack of specialist support, reduction in mobility and life roles, negative body image, impaired self-efficacy and self-esteem are considered most relevant factors. Investigation of predictors of post-stroke quality of life in young-onset patients is needed to design, implement, and evaluate specific young stroke rehabilitation and stroke self-management programmes.
The aim of the study is to assess the predictors of the health-related quality of life in young patients under 50 years after ischemic stroke, and to evaluate specific changes in different dimensions of health-related quality of life during the first year of post-stroke recovery using a standardized battery of neuropsychological tools and stroke specific health-related quality of life measures. The aims of the study will be met by the triangulation of qualitative and quantitative research methods.
In the first phase of the study, 300 IS patients will be enrolled for the validation of the Czech version of the the Stroke Impact Scale 3.0. The reliability and validity study will have a cross-sectional design. In the second phase of study, 200 enrolled IS patients (100 young IS patients < 50 years and 100 IS patients of 50-65 years) will undergo a serial of structured and standardized questionnaires during scheduled outpatients' controls three, six and 12 months after IS. In all enrolled patients, the functional outcome, neuropsychological status and quality of life will be assessed using standardized scales and tools. In the third phase of study, twenty young IS patients < 50 years will undergo an in-depth, semi-structured interview with explanatory questions that will allow a detailed understanding of the patient's experience. Interpretative phenomenological analysis (IPA) study design will be used.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Validation study | – | –Three hundred patients with ischemic stroke (18-65 years) will be enrolled for the validation of the Czech version of the the Stroke Impact Scale 3.0. The reliability and validity study will have a cross-sectional design. |
| Prospective quantitative study | – | –Two hundred enrolled IS patients (100 young IS patients < 50 years and 100 IS patients of 50-65 years) will undergo a serial of structured and standardized questionnaires during scheduled outpatients' controls three, six and 12 months after IS. In all enrolled patients, the functional outcome, neuropsychological status and quality of life will be assessed using standardized scales and tools. |
| In-depth interview qualitative study | – | –twenty young IS patients < 50 years will undergo an in-depth, semi-structured interview with explanatory questions that will allow a detailed understanding of the patient's experience. Interpretative phenomenological analysis (IPA) study design will be used. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Participants will be recruited from individuals, diagnosed with ischemic stroke according to the ICD-10 classification who will be admitted to the stroke unit.
Key inclusion criteria (2 listed)
- Acute ischemic stroke
- Age 18-65 years
Key exclusion criteria (6 listed)
- Transient ischemic attack without progression to ischemic stroke
- Haemorrhagic stroke
- Severe cognitive impairment
- Severe communication disorder (sensory aphasia with the inability to understand having been verified by a certified speech therapist)
- Concomitant severe systemic illness
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 in the Stroke Impact Scale (version 3.0)
Time frame: three, six and 12 months after stroke
Assessment of the impact of stroke on eight domains relating to self-rated quality of life, self-perceived disability, and global recovery after stroke (i.e., strength, hand function, mobility, physical and instrumental activities of daily living, memory and thinking, communication, emotion, and social participation). Scores for each domain range from 0 to 100, and higher scores indicate a better health related quality of life
7 secondary outcomes
Change of the World Health Organization Quality of Life - BREF version (WHOQOL-BREF, self-reported)
Time frame: three, six and 12 months after stroke
Change of the Barthel Index of Activities of Daily Living (self-reported)
Time frame: three, six and 12 months after stroke
Change of Modified Rankin Scale (self-reported)
Time frame: three, six and 12 months after stroke
Change of post-stroke depression and anxiety (self-reported)
Time frame: three, six and 12 months after stroke
Change of the Montreal Cognitive Assessment (MoCA)
Time frame: three, six and 12 months after stroke
Change from 3-month the lived experience of ischemic stroke of young patients up to 50 years at 12 months.
Time frame: three and 12 months after stroke
Change in the NIH Stroke Scale (NIHSS)
Time frame: three, six and 12 months after stroke
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2024.
- Results publication: PubMed 24655479Arntz RM, van Alebeek ME, Synhaeve NE, Brouwers PJ, van Dijk GW, Gons RA, den Heijer T, de Kort PL, de Laat KF, van Norden AG, Vermeer SE, van der Vlugt MJ, Kessels RP, van Dijk EJ, de Leeuw FE. Observational Dutch Young Symptomatic StrokE studY (ODYSSEY): study rationale and protocol of a multicentre prospective cohort study. BMC Neurol. 2014 Mar 22;14:55. doi: 10.1186/1471-2377-14-55.
- Results publication: PubMed 32912563Bartholome L, Winter Y. Quality of Life and Resilience of Patients With Juvenile Stroke: A Systematic Review. J Stroke Cerebrovasc Dis. 2020 Oct;29(10):105129. doi: 10.1016/j.jstrokecerebrovasdis.2020.105129. Epub 2020 Jul 15.
- Results publication: PubMed 32015089Boot E, Ekker MS, Putaala J, Kittner S, De Leeuw FE, Tuladhar AM. Ischaemic stroke in young adults: a global perspective. J Neurol Neurosurg Psychiatry. 2020 Apr;91(4):411-417. doi: 10.1136/jnnp-2019-322424. Epub 2020 Feb 3.
- Results publication: PubMed 26215135de Bruijn MA, Synhaeve NE, van Rijsbergen MW, de Leeuw FE, Mark RE, Jansen BP, de Kort PL. Quality of Life after Young Ischemic Stroke of Mild Severity Is Mainly Influenced by Psychological Factors. J Stroke Cerebrovasc Dis. 2015 Oct;24(10):2183-8. doi: 10.1016/j.jstrokecerebrovasdis.2015.04.040. Epub 2015 Jul 26.
- Results publication: PubMed 27176617Douven E, Schievink SH, Verhey FR, van Oostenbrugge RJ, Aalten P, Staals J, Kohler S. The Cognition and Affect after Stroke - a Prospective Evaluation of Risks (CASPER) study: rationale and design. BMC Neurol. 2016 May 12;16:65. doi: 10.1186/s12883-016-0588-1.
- Results publication: PubMed 30129475Ekker MS, Boot EM, Singhal AB, Tan KS, Debette S, Tuladhar AM, de Leeuw FE. Epidemiology, aetiology, and management of ischaemic stroke in young adults. Lancet Neurol. 2018 Sep;17(9):790-801. doi: 10.1016/S1474-4422(18)30233-3.
- Results publication: PubMed 25128182Harno H, Haapaniemi E, Putaala J, Haanpaa M, Makela JP, Kalso E, Tatlisumak T. Central poststroke pain in young ischemic stroke survivors in the Helsinki Young Stroke Registry. Neurology. 2014 Sep 23;83(13):1147-54. doi: 10.1212/WNL.0000000000000818. Epub 2014 Aug 15.
- Results publication: PubMed 32735024Heiberg G, Friborg O, Pedersen SG, Thrane G, Holm Stabel H, Feldbaek Nielsen J, Anke A. Post-stroke health-related quality of life at 3 and 12 months and predictors of change in a Danish and Arctic Norwegian Region. J Rehabil Med. 2020 Sep 8;52(9):jrm00096. doi: 10.2340/16501977-2716.
- Results publication: PubMed 31272664Kapoor A, Scott C, Lanctot KL, Herrmann N, Murray BJ, Thorpe KE, Lien K, Sicard M, Swartz RH. Symptoms of depression and cognitive impairment in young adults after stroke/transient ischemic attack. Psychiatry Res. 2019 Sep;279:361-363. doi: 10.1016/j.psychres.2019.06.022. Epub 2019 Jul 1.
- Results publication: PubMed 32745720Kono Y, Terasawa Y, Sakai K, Iguchi Y, Nishiyama Y, Nito C, Suda S, Kimura K, Kanzawa T, Imafuku I, Nakayama T, Ueda M, Iwanaga T, Kono T, Yamashiro K, Tanaka R, Okubo S, Nakajima M, Nakajima N, Mishina M, Yaguchi H, Oka H, Suzuki M, Osaki M, Kaneko N, Kitagawa K, Okamoto S, Nomura K, Yamazaki M, Nagao T, Murakami Y. Risk factors, etiology, and outcome of ischemic stroke in young adults: A Japanese multicenter prospective study. J Neurol Sci. 2020 Oct 15;417:117068. doi: 10.1016/j.jns.2020.117068. Epub 2020 Jul 29.
- Results publication: PubMed 31678939Lam KH, Blom E, Kwa VIH. Predictors of quality of life 1 year after minor stroke or TIA: a prospective single-centre cohort study. BMJ Open. 2019 Nov 2;9(11):e029697. doi: 10.1136/bmjopen-2019-029697.
- Results publication: PubMed 25362090Maaijwee NA, Arntz RM, Rutten-Jacobs LC, Schaapsmeerders P, Schoonderwaldt HC, van Dijk EJ, de Leeuw FE. Post-stroke fatigue and its association with poor functional outcome after stroke in young adults. J Neurol Neurosurg Psychiatry. 2015 Oct;86(10):1120-6. doi: 10.1136/jnnp-2014-308784. Epub 2014 Oct 31.
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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.
Elena Gurkova, PhD principal investigator
Palacky University, Faculty of Health Sciences, Department of Nursing
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 Ischemic Stroke, run by Elena Gurkova at 1 site in Czechia.
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 2 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 4 Apr 2024. 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 Czechia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elena Gurkova, PhD (+420585632825, elena.gurkova@upol.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Stroke Impact Scale (version 3.0) (time frame: three, six and 12 months after stroke). 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 NCT04839887, which also lists 23 linked publications.
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 4 Apr 2024.