StrokeQoLSMSNCT04758494
Quality of Life Assessment Between Stroke and Multiple Sclerosis Patients of the Same Age Range
An observational study of Stroke and Multiple Sclerosis, run by Hellenic Red Cross Hospital at 1 site in Greece.
Trial summary
The purpose of this study is to investigate the physical, psychological, social and functional aspects of life in relatively young people suffering from vascular stroke and in people diagnosed with multiple sclerosis of the same age group and to generally assess the subjective perception of these patients about their… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Stroke, Multiple Sclerosis, Quality of Life
- What is being tested?
- Questionnaire
- How many people
- 172 participants
- Where
- 1 siteGreece
- Study dates
- 11 Nov 2019to 10 Nov 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: In the present study the sample were patients with ischemic or hemorrhagic stroke or multiple sclerosis (regardless of EDSS). All participants belonged to the age group 18-60, ie they reflected the usual age when the person is professionally active in most parts of the world. These are, after all, the age limits used by the World Health Organization. The sample was randomly selected through stratification with representation of patients based on gender, age category and geographical location. Data on age, sex, race, marital status, occupation, educational level, plus morbidity, were identified from medical records and self-reports.
Who may be able to join
- Greek citizenship
- Age 18-60 years
- Hospitalization at the department of Neurology, G. Gennimatas Hospital or at the department of Vascular Surgery and/or Neurosurgery, Hellenic Red Cross Hospital
- Diagnosis of ischemic or hemorrhagic stroke or multiple sclerosis at discharge from hospital
Who cannot join
- Alien citizenship
- Age below 18 or above 60 years
- Mental or physical disability history before the diagnosis of stroke or multiple sclerosis
- Second stroke during the period of the study
- History of dementia
- Symptoms of aphasia or individuals in comatose state (high NIHS)
- Individuals with stroke in the frontal lobe
Trial locations and contacts
1 site in 1 country.
Greece1 site
Department of Vascular Surgery, Hellenic Red Cross Hospital
Athens, 11526
About this study
Official title: A Study to Assess Quality of Life in Stroke and Multiple Sclerosis Patients of the Same Age Range
The purpose of this study is to investigate the physical, psychological, social and functional aspects of life in relatively young people suffering from vascular stroke and in people diagnosed with multiple sclerosis of the same age group and to generally assess the subjective perception of these patients about their general health and well-being. In addition, to assess the degree of depression experienced by people in this age group who suffer from these diseases. Additional objectives are to investigate important factors that negatively affect the quality of life in this group of patients, according to the international literature, and to highlight targeted interventions to promote mental and physical health in order to improve the quality of life in these chronic patients.
Read the detailed description
Research on the importance of quality of life in chronic neurological patients has occasionally occupied the international scientific community. Due to the large scale of strokes occurring at young ages as well as multiple sclerosis, more and more research is focusing on the quality of life of these individuals.
The present study is retrospective as well as prospective. The purpose of this study is to investigate the physical, psychological, social and functional aspects of life in relatively young people suffering from vascular stroke and in people diagnosed with multiple sclerosis of the same age group and to generally assess the subjective perception of these patients about their general health and well-being. In addition, to assess the degree of depression experienced by people in this age group who suffer from these diseases. Additional objectives are to investigate important factors that negatively affect the quality of life in this group of patients, according to the international literature, and to highlight targeted interventions to promote mental and physical health in order to improve the quality of life in these chronic patients.
In particular, the research questions that this study is trying to answer are:
- Do young stroke patients exhibit the same quality of life as healthy populations of the same age?
- Do young people with multiple sclerosis have the same quality of life as the healthy population of the same age?
- Do young people with stroke have the same quality of life as patients with multiple sclerosis of the same age?
- Are patients (either with multiple sclerosis or stroke) with almost the same degree of physical independence and are older patients characterized by greater depression and reduced quality of life compared to younger ones?
- Is degree of disability associated with decreased quality of life and increased depression between the two groups of chronic patients?
- Does gender affect the quality of life and the presence of depression?
- Do marital and economic status affect the indicators of depression and quality of life in both populations to be investigated?
- Is location of living a factor that contributes to the reduced quality of life and the triggering of depression in young people with stroke and multiple sclerosis compared to the healthy population?
- Conditions
- Stroke, Multiple Sclerosis, Quality of Life, Depression, Mental Health Disorder
- Being tested
- Questionnaire
- Keywords
- stroke, multiple sclerosis, quality of life, mental health, depression, anxiety, well-being, wellness, neurological disorder
- Medical subject headings
- Stroke, Multiple Sclerosis, Depression, Mental Disorders, Psychological Well-Being, Anxiety Disorders, Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
In the present study a questionnaire was designed by combining three separate questionnaires, which were weighted for use in Greek population and which are often being used to investigate quality of life of young populations diagnosed with stroke or multiple sclerosis, according to international literature. Those were the following questionnaires: Bathrel (Mahoney et al), Patient Health Questionairre (PHQ-9) (Thomson K et al), Health Survey SF-12 (Kontodinopoulos et al 2007). A draft questionnaire was then created with the addition of questions deemed necessary to provide necessary research information. Overall the questionnaire consisted of 42 questions.
Part A The first part of the questionnaire included demographics of participants. Part B. The second part of the questionnaire included an assessment of the functionality and independence, an evaluation of experienced depression and an assessment of the quality of life of the target population.
| Study group | Role | What they receive |
|---|---|---|
| Stroke1-hemiparesis | Patients diagnosed with an ischemic/hemorrhagic stroke and clinical hemiparesis. Receives: Other: Questionnaire | |
| Stroke 2-mild stroke | Patients diagnosed with an ischemic/hemorrhagic stroke and clinical symptoms of a mild stroke. Receives: Other: Questionnaire | |
| Stroke 3-speech disorder | Patients diagnosed with an ischemic/hemorrhagic stroke and clinical symptoms of a speech disorder. Receives: Other: Questionnaire | |
| Stroke 4-hemiparesis mainly of upper limb | Patients diagnosed with an ischemic/hemorrhagic stroke and clinical hemiparesis mainly of upper limb. Receives: Other: Questionnaire | |
| Stroke 5-memory loss and depression | Patients diagnosed with an ischemic/hemorrhagic stroke and clinical symptoms of memory loss and depression. Receives: Other: Questionnaire | |
| Multiple Sclerosis | Patients diagnosed with multiple sclerosis. Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Barthel score
The Barthel Scale/Index (BI) is an ordinal scale used to measure performance in activities of daily living (ADL). Ten variables describing ADL and mobility are scored from 0 (total dependence) up to 3 (total independence), a higher number being a reflection of greater ability to function independently following hospital discharge.Time taken and physical assistance required to perform each item are used in determining the assigned value of each item. The Barthel Index measures the degree of assistance required by an individual on 10 items of mobility and self care ADL (lowest score=0, highest score=20).
Measured: Through study completion, an average of 1 year
PHQ-9 score
The Patient Health Questionnaire-9 (PHQ-9) is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression. The tool rates the frequency of the symptoms which factors into the scoring severity index. Question 9 on the PHQ-9 screens for the presence and duration of suicide ideation. A follow up, non-scored question on the PHQ-9 screens and assigns weight to the degree to which depressive problems have affected the patient's level of function. The PHQ-9 is brief and useful in clinical practice. The PHQ-9 is completed by the patient in minutes and is rapidly scored by the clinician. The higher the total score, the worse the depression the patient exhibits. Minimum score=0 indicates absence of depression, and maximum score=27 indicates severe depression. Scores of 5, 10, 15, and 20 represent cutpoints for mild, moderate, moderately severe and severe depression, respectively.
Measured: Through study completion, an average of 1 year
SF12-physical component summary (PCS) score
The Short Form-12 (SF-12) is a self-reported outcome measure assessing the impact of health on an individual's everyday life. It is often used as a quality of life measure. The SF-12 is a shortened version of it's predecessor, the SF-36, which itself evolved from the Medical Outcomes Study. It consists of 12 items, each one scored in a given scale. Each item's scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. Two subscales are derived from the SF-12: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). The physical component of SF-12 measures physical functioning, role limitations due to physical health problems, bodily pain, general health, and vitality (energy/fatigue).
Measured: Through study completion, an average of 1 year
SF12-mental component summary (MCS) score
The Short Form-12 (SF-12) is a self-reported outcome measure assessing the impact of health on an individual's everyday life. It is often used as a quality of life measure. The SF-12 is a shortened version of it's predecessor, the SF-36, which itself evolved from the Medical Outcomes Study. It consists of 12 items, each one scored in a given scale. Each item's scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. Two subscales are derived from the SF-12: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). The mental component of SF-12 measures social functioning, role limitations due to emotional problems, and mental health (psychological distress and psychological well-being).
Measured: Through study completion, an average of 1 year
Depression severity level
Depression severity was assessed according to Patient Health Questionnaire-9 (PHQ-9) score from 0-27 (see above) and then characterized by using five distinctive levels, namely: None (0-4), Mild (5-9), Moderate (10-14), Moderate severe (15-19) and Severe (20-27).
Measured: Through study completion, an average of 1 year
Dependency category
Categorization of patient dependency was done according to Barthel score from 0-100 (see above) by using four distinctive categories, namely: Total (0-20), Severe (21-60), Moderate (61-90) and Slight (91-100).
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2021
- Study start11 Nov 2019
- Primary completion10 Nov 2020
- Study completion10 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- 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
- Case-control
- Time perspective
- Other
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hellenic Red Cross Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- G.Gennimatas General Hospital
- Responsible party
- Principal investigator, Konstantinos Roditis, MD, MSc, Hellenic Red Cross Hospital
- Investigators
- Konstantinos Roditis, MD, MSc, Principal investigator, Department of Vascular Surgery, Hellenic Red Cross Hospital, Athens, GreeceTheofanis T Papas, MD, MSc, PhD, Study director, Department of Vascular Surgery, Hellenic Red Cross Hospital, Athens, GreeceNikolaos Bessias, MD, MSc, PhD, Study chair, Department of Vascular Surgery, Hellenic Red Cross Hospital, Athens, Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04758494
- Sponsor's protocol ID
- 257/19-12-2019
- Other IDs
- 3320/06-02-2020
- Acronym
- QoLSMS
- Status last verified
- Feb 2021
- First submitted
- 9 Feb 2021
- Last updated
- 17 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
MAHONEY FI, BARTHEL DW. FUNCTIONAL EVALUATION: THE BARTHEL INDEX. Md State Med J. 1965 Feb;14:61-5. No abstract available.
PubMed 14258950WYLIE CM, WHITE BK. A MEASURE OF DISABILITY. Arch Environ Health. 1964 Jun;8:834-9. doi: 10.1080/00039896.1964.10663764. No abstract available.
PubMed 14157579Imhof L, Suter-Riederer S, Kesselring J. Effects of Mobility-Enhancing Nursing Intervention in Patients with MS and Stroke: Randomised Controlled Trial. Int Sch Res Notices. 2015 Feb 17;2015:785497. doi: 10.1155/2015/785497. eCollection 2015.
PubMed 27347547Altura KC, Patten SB, Fiest KM, Atta C, Bulloch AG, Jette N. Suicidal ideation in persons with neurological conditions: prevalence, associations and validation of the PHQ-9 for suicidal ideation. Gen Hosp Psychiatry. 2016 Sep-Oct;42:22-6. doi: 10.1016/j.genhosppsych.2016.06.006. Epub 2016 Jul 5.
PubMed 27638967Hausmann J, Sweeney-Reed CM, Sobieray U, Matzke M, Heinze HJ, Voges J, Buentjen L. Functional electrical stimulation through direct 4-channel nerve stimulation to improve gait in multiple sclerosis: a feasibility study. J Neuroeng Rehabil. 2015 Nov 14;12:100. doi: 10.1186/s12984-015-0096-3.
PubMed 26577467Yoo SH, Kim SR, So HS, Chung HC, Chae DH, Kim MK, Kim BC, Park MS, Lee SH, Nam TS, Correia H, Cella D. The Validity and Reliability of the Korean Version of the Stigma Scale for Chronic Illness 8-Items (SSCI-8) in Patients with Neurological Disorders. Int J Behav Med. 2017 Apr;24(2):288-293. doi: 10.1007/s12529-016-9593-4.
PubMed 27900731Thompson K, D'iuso D, Schwartzman D, Dobson KS, Drapeau M. Changes in depressed patients' self-statements. Psychother Res. 2020 Feb;30(2):170-182. doi: 10.1080/10503307.2018.1543976. Epub 2018 Nov 13.
PubMed 30422103
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Assess Quality of Life in Stroke and Multiple Sclerosis Patients of the Same Age Range
- ClinicalTrials.gov ID
- NCT04758494
- Acronym / sponsor ID
- QoLSMS / 257/19-12-2019
- Conditions
- Stroke, Multiple Sclerosis, Quality of Life, Depression, Mental Health Disorder
- Keywords
- stroke, multiple sclerosis, quality of life, mental health, depression, anxiety, well-being, wellness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- Hellenic Red Cross HospitalUniversity, hospital or other
- Collaborators
- G.Gennimatas General Hospital
- Study start
- 11 Nov 2019 (actual)
- Primary completion
- 10 Nov 2020 (actual)
- Study completion
- 10 Nov 2020 (actual)
- First posted
- 17 Feb 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.
The purpose of this study is to investigate the physical, psychological, social and functional aspects of life in relatively young people suffering from vascular stroke and in people diagnosed with multiple sclerosis of the same age group and to generally assess the subjective perception of these patients about their general health and well-being. In addition, to assess the degree of depression experienced by people in this age group who suffer from these diseases. Additional objectives are to investigate important factors that negatively affect the quality of life in this group of patients, according to the international literature, and to highlight targeted interventions to promote mental and physical health in order to improve the quality of life in these chronic patients.
Detailed description
Research on the importance of quality of life in chronic neurological patients has occasionally occupied the international scientific community. Due to the large scale of strokes occurring at young ages as well as multiple sclerosis, more and more research is focusing on the quality of life of these individuals.
The present study is retrospective as well as prospective. The purpose of this study is to investigate the physical, psychological, social and functional aspects of life in relatively young people suffering from vascular stroke and in people diagnosed with multiple sclerosis of the same age group and to generally assess the subjective perception of these patients about their general health and well-being. In addition, to assess the degree of depression experienced by people in this age group who suffer from these diseases. Additional objectives are to investigate important factors that negatively affect the quality of life in this group of patients, according to the international literature, and to highlight targeted interventions to promote mental and physical health in order to improve the quality of life in these chronic patients.
In particular, the research questions that this study is trying to answer are:
- Do young stroke patients exhibit the same quality of life as healthy populations of the same age?
- Do young people with multiple sclerosis have the same quality of life as the healthy population of the same age?
- Do young people with stroke have the same quality of life as patients with multiple sclerosis of the same age?
- Are patients (either with multiple sclerosis or stroke) with almost the same degree of physical independence and are older patients characterized by greater depression and reduced quality of life compared to younger ones?
- Is degree of disability associated with decreased quality of life and increased depression between the two groups of chronic patients?
- Does gender affect the quality of life and the presence of depression?
- Do marital and economic status affect the indicators of depression and quality of life in both populations to be investigated?
- Is location of living a factor that contributes to the reduced quality of life and the triggering of depression in young people with stroke and multiple sclerosis compared to the healthy population?
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Stroke1-hemiparesis | – | Other: QuestionnairePatients diagnosed with an ischemic/hemorrhagic stroke and clinical hemiparesis. |
| Stroke 2-mild stroke | – | Other: QuestionnairePatients diagnosed with an ischemic/hemorrhagic stroke and clinical symptoms of a mild stroke. |
| Stroke 3-speech disorder | – | Other: QuestionnairePatients diagnosed with an ischemic/hemorrhagic stroke and clinical symptoms of a speech disorder. |
| Stroke 4-hemiparesis mainly of upper limb | – | Other: QuestionnairePatients diagnosed with an ischemic/hemorrhagic stroke and clinical hemiparesis mainly of upper limb. |
| Stroke 5-memory loss and depression | – | Other: QuestionnairePatients diagnosed with an ischemic/hemorrhagic stroke and clinical symptoms of memory loss and depression. |
| Multiple Sclerosis | – | Other: QuestionnairePatients diagnosed with multiple sclerosis. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- In the present study the sample were patients with ischemic or hemorrhagic stroke or multiple sclerosis (regardless of EDSS). All participants belonged to the age group 18-60, ie they reflected the usual age when the person is professionally active in most parts of the world. These are, after all, the age limits used by the World Health Organization. The sample was randomly selected through stratification with representation of patients based on gender, age category and geographical location. Data on age, sex, race, marital status, occupation, educational level, plus morbidity, were identified from medical records and self-reports.
Key inclusion criteria (4 listed)
- Greek citizenship
- Age 18-60 years
- Hospitalization at the department of Neurology, G. Gennimatas Hospital or at the department of Vascular Surgery and/or Neurosurgery, Hellenic Red Cross Hospital
- Diagnosis of ischemic or hemorrhagic stroke or multiple sclerosis at discharge from hospital
Key exclusion criteria (7 listed)
- Alien citizenship
- Age below 18 or above 60 years
- Mental or physical disability history before the diagnosis of stroke or multiple sclerosis
- Second stroke during the period of the study
- History of dementia
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 |
|---|---|---|
| QuestionnaireIn the present study a questionnaire was designed by combining three separate questionnaires, which were weighted for use in Greek population and which are often being used to investigate quality of life of young populations diagnosed with stroke or multiple sclerosis, according to international literature. Those were the following questionnaires: Bathrel (Mahoney et al), Patient Health Questionairre (PHQ-9) (Thomson K et al), Health Survey SF-12 (Kontodinopoulos et al 2007). A draft questionnaire was then created with the addition of questions deemed necessary to provide necessary research information. Overall the questionnaire consisted of 42 questions. Part A The first part of the questionnaire included demographics of participants. Part B. The second part of the questionnaire included an assessment of the functionality and independence, an evaluation of experienced depression and an assessment of the quality of life of the target population. | Other | Multiple Sclerosis, Stroke 2-mild stroke, Stroke 3-speech disorder, Stroke 4-hemiparesis mainly of upper limb, Stroke 5-memory loss and depression, Stroke1-hemiparesis |
Primary outcome
Barthel score
Time frame: Through study completion, an average of 1 year
The Barthel Scale/Index (BI) is an ordinal scale used to measure performance in activities of daily living (ADL). Ten variables describing ADL and mobility are scored from 0 (total dependence) up to 3 (total independence), a higher number being a reflection of greater ability to function independently following hospital discharge.Time taken and physical assistance required to perform each item are used in determining the assigned value of each item. The Barthel Index measures the degree of assistance required by an individual on 10 items of mobility and self care ADL (lowest score=0, highest score=20).
PHQ-9 score
Time frame: Through study completion, an average of 1 year
The Patient Health Questionnaire-9 (PHQ-9) is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression. The tool rates the frequency of the symptoms which factors into the scoring severity index. Question 9 on the PHQ-9 screens for the presence and duration of suicide ideation. A follow up, non-scored question on the PHQ-9 screens and assigns weight to the degree to which depressive problems have affected the patient's level of function. The PHQ-9 is brief and useful in clinical practice. The PHQ-9 is completed by the patient in minutes and is rapidly scored by the clinician. The higher the total score, the worse the depression the patient exhibits. Minimum score=0 indicates absence of depression, and maximum score=27 indicates severe depression. Scores of 5, 10, 15, and 20 represent cutpoints for mild, moderate, moderately severe and severe depression, respectively.
SF12-physical component summary (PCS) score
Time frame: Through study completion, an average of 1 year
The Short Form-12 (SF-12) is a self-reported outcome measure assessing the impact of health on an individual's everyday life. It is often used as a quality of life measure. The SF-12 is a shortened version of it's predecessor, the SF-36, which itself evolved from the Medical Outcomes Study. It consists of 12 items, each one scored in a given scale. Each item's scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. Two subscales are derived from the SF-12: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). The physical component of SF-12 measures physical functioning, role limitations due to physical health problems, bodily pain, general health, and vitality (energy/fatigue).
SF12-mental component summary (MCS) score
Time frame: Through study completion, an average of 1 year
The Short Form-12 (SF-12) is a self-reported outcome measure assessing the impact of health on an individual's everyday life. It is often used as a quality of life measure. The SF-12 is a shortened version of it's predecessor, the SF-36, which itself evolved from the Medical Outcomes Study. It consists of 12 items, each one scored in a given scale. Each item's scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. Two subscales are derived from the SF-12: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). The mental component of SF-12 measures social functioning, role limitations due to emotional problems, and mental health (psychological distress and psychological well-being).
Depression severity level
Time frame: Through study completion, an average of 1 year
Depression severity was assessed according to Patient Health Questionnaire-9 (PHQ-9) score from 0-27 (see above) and then characterized by using five distinctive levels, namely: None (0-4), Mild (5-9), Moderate (10-14), Moderate severe (15-19) and Severe (20-27).
Dependency category
Time frame: Through study completion, an average of 1 year
Categorization of patient dependency was done according to Barthel score from 0-100 (see above) by using four distinctive categories, namely: Total (0-20), Severe (21-60), Moderate (61-90) and Slight (91-100).
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 17 Feb 2021.
- Background: PubMed 14258950MAHONEY FI, BARTHEL DW. FUNCTIONAL EVALUATION: THE BARTHEL INDEX. Md State Med J. 1965 Feb;14:61-5. No abstract available.
- Background: PubMed 14157579WYLIE CM, WHITE BK. A MEASURE OF DISABILITY. Arch Environ Health. 1964 Jun;8:834-9. doi: 10.1080/00039896.1964.10663764. No abstract available.
- Background: PubMed 27347547Imhof L, Suter-Riederer S, Kesselring J. Effects of Mobility-Enhancing Nursing Intervention in Patients with MS and Stroke: Randomised Controlled Trial. Int Sch Res Notices. 2015 Feb 17;2015:785497. doi: 10.1155/2015/785497. eCollection 2015.
- Background: PubMed 27638967Altura KC, Patten SB, Fiest KM, Atta C, Bulloch AG, Jette N. Suicidal ideation in persons with neurological conditions: prevalence, associations and validation of the PHQ-9 for suicidal ideation. Gen Hosp Psychiatry. 2016 Sep-Oct;42:22-6. doi: 10.1016/j.genhosppsych.2016.06.006. Epub 2016 Jul 5.
- Background: PubMed 26577467Hausmann J, Sweeney-Reed CM, Sobieray U, Matzke M, Heinze HJ, Voges J, Buentjen L. Functional electrical stimulation through direct 4-channel nerve stimulation to improve gait in multiple sclerosis: a feasibility study. J Neuroeng Rehabil. 2015 Nov 14;12:100. doi: 10.1186/s12984-015-0096-3.
- Background: PubMed 27900731Yoo SH, Kim SR, So HS, Chung HC, Chae DH, Kim MK, Kim BC, Park MS, Lee SH, Nam TS, Correia H, Cella D. The Validity and Reliability of the Korean Version of the Stigma Scale for Chronic Illness 8-Items (SSCI-8) in Patients with Neurological Disorders. Int J Behav Med. 2017 Apr;24(2):288-293. doi: 10.1007/s12529-016-9593-4.
- Background: PubMed 30422103Thompson K, D'iuso D, Schwartzman D, Dobson KS, Drapeau M. Changes in depressed patients' self-statements. Psychother Res. 2020 Feb;30(2):170-182. doi: 10.1080/10503307.2018.1543976. Epub 2018 Nov 13.
- Individual participant dataSharing planned: No
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
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.
Konstantinos Roditis, MD, MSc principal investigator
Department of Vascular Surgery, Hellenic Red Cross Hospital, Athens, Greece
Theofanis T Papas, MD, MSc, PhD study director
Department of Vascular Surgery, Hellenic Red Cross Hospital, Athens, Greece
Nikolaos Bessias, MD, MSc, PhD study chair
Department of Vascular Surgery, Hellenic Red Cross Hospital, Athens, Greece
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 Multiple Sclerosis, run by Hellenic Red Cross Hospital at 1 site in Greece.
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 7 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 17 Feb 2021. 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 Greece. 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?
Barthel score (time frame: Through study completion, an average of 1 year). The study lists 6 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 NCT04758494, which also lists 7 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 17 Feb 2021.