StrokeStrokeNCT03355690
The Care of Stroke in Ziekenhuis Oost-Limburg
An observational study of Stroke, run by Ziekenhuis Oost-Limburg at 1 site in Belgium.
Trial summary
A stroke occurs when the blood circulation is hampered due an ischemic or hemorrhagic event. Previous, a stroke was treated only with anti-aggregation. Over time, multiple studies have showed a positive effect of intravenous thrombolysis with rt-PA (recombinant tissue plasminogen activator) in comparison with the… Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Stroke
- How many people
- 564 participants
- Where
- 1 siteBelgium
- Study dates
- 15 Dec 2017to 15 Dec 2019
- How long will I take part?
- 12 Months
- 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 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients (older than 18 years) diagnosed with stroke will be asked to parcipate. When the patient is not approachable for participation, the next of kin will be informed. An informed consent has to be obtained before study participation.
Who may be able to join
- signed informed consent
- older than 18 years
- diagnosed with stroke
Who cannot join
- younger than 18 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Care of Stroke in the Hospital of Genk: Outcome After Treatment and the Health-economic Impact of Stroke in the Patient Population
A stroke occurs when the blood circulation is hampered due an ischemic or hemorrhagic event. Previous, a stroke was treated only with anti-aggregation. Over time, multiple studies have showed a positive effect of intravenous thrombolysis with rt-PA (recombinant tissue plasminogen activator) in comparison with the standard treatment (anti-aggregation). Since 2015, thrombectomy was proven to have an added value in combination with thrombolysis. Thrombectomy is an endovascular technique where the thrombus is removed or fragmented.
Diagnosis and treatment of stroke will have a significant impact on the health-economic status of the patient. However, little data is known. Unfortunately, the outcome after diagnosis with a stroke is not well documented. Therefore, this follow-up study over a time period of one year, will give us a sufficient amount of data to evaluate patients diagnosed with a stroke in the hospital of Genk.
- Conditions
- Stroke
- Keywords
- thrombectomy, thrombolysis, Health-economic status, Outcome after stroke
- Medical subject headings
- 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 |
|---|---|---|
| Stroke patients | Stroke patients are treated according to the clinical practice which can be divided into: anti-aggregation, thrombectomy and/or thrombolysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified rankin scale
Change in modified rankin scale over time: baseline (diagnosis stroke), 3 months and one year follow-up. Modified rankin scale is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke.
The scale runs from 0-6, running from perfect health without symptoms to death.
0 - No symptoms.
- - No significant disability. Able to carry out all usual activities, despite some symptoms.
- - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
- - Moderate disability. Requires some help, but able to walk unassisted.
- - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
- - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
- - Dead.
Measured: day 1, 3 months and 12 months
Secondary outcomes (8)
Rehabilitation: evaluation muscle strength
Change in muscle strength over time: baseline (diagnosis stroke), 3 months and one year follow-up. Muscle strength is assessed in both arms and legs according to the score below.
0: no movement 9: palpable flicker but no movement 14: movement but not against gravity 19: movement against gravity 25: movement against resistance 33: normal The scores for arms and legs are counted together and divided by 2.
Measured: day 1, 3 months and 12 months
Rehabilitation: evaluation arm/hand function
Change in arm/hand function over time: baseline (diagnosis stroke), 3 months and one year follow-up. 5 small tests are performed. The total score can vary from 0 to 5, with lower scores indicating decreased arm/hand function.
Measured: day 1, 3 months and 12 months
Rehabilitation: walking capability
Change in walking capability over time: baseline (diagnosis stroke), 3 months and one year follow-up. Test: if the patient is able to walk, he/she has to walk 10 meters and is recorded as meter per second.
Measured: day 1, 3 months and 12 months
Rehabilitation: trunk control test
Change in trunk activity over time: baseline (diagnosis stroke), 3 months and one year follow-up. Trunk control test examines four movements: rolling from a supine position to the weak side and to the strong side, sitting up from a lying-down position, and sitting balance.
Each item is scored as indicated below:
0: no movement 12: movement with corrections 25: normal The total score counts the four tests together. The maximum possible score is 100, with the minimum score being a 0.
Measured: day 1, 3 months and 12 months
National Institutes of Health Stroke Scale (NIHSS)
Change in NIHSS over time: baseline (diagnosis stroke), 3 months and one year follow-up. The National Institutes of Health Stroke Scale (NIHSS) is a tool used by healthcare providers to objectively quantify the impairment caused by a stroke. The NIHSS is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score being a 0.
Measured: day 1, 3 months and 12 months
Quality of life-EQ5D
Change in quality of life over time: baseline (diagnosis stroke), 3 months and one year follow-up. The European Quality of life system comprises 5 dimensions (EQ5D): mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels varying from no problems to extreme problems.
Measured: day 1, 3 months and 12 months
Quality of life-Barthel index
Change in quality of life over time: baseline (diagnosis stroke), 3 months and one year follow-up. The barthel index is an index that represent the capacity to perform daily activities (feeding, grooming, toilet use, stairs, bathing,...). Total possible scores range from 0 - 20, with lower scores indicating increased disability.
Measured: day 1, 3 months and 12 months
Quality of life-stroke specific quality of life scale
Change in quality of life over time: baseline (diagnosis stroke), 3 months and one year follow-up. The Stroke-Specific Quality of Life scale (SSQOL) is a questionnaire that evaluates different activities performed in the last week (language, mobility, personality, writing, thinking, mood, vision,...). Each item is scored with a maximum of 5 points. The higher the score, the more problems the patient will have with their daily activities.
Measured: day 1, 3 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2017
- Study start15 Dec 2017
- Primary completion15 Dec 2019
- Study completion15 Dec 2019
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 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
- 564 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Ziekenhuis Oost-Limburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dieter Mesotten, Ziekenhuis Oost-Limburg
- Investigators
- Sofie Vancauter, MD PhD, Principal investigator, Ziekenhuis Oost-Limburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03355690
- Sponsor's protocol ID
- B371201733371/I/U
- Acronym
- Stroke
- Status last verified
- Apr 2023
- First submitted
- 10 Oct 2017
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lesenne A, Grieten J, Ernon L, Wibail A, Stockx L, Wouters PF, Dreesen L, Vandermeulen E, Van Boxstael S, Vanelderen P, Van Poucke S, Vundelinckx J, Van Cauter S, Mesotten D. Prediction of Functional Outcome After Acute Ischemic Stroke: Comparison of the CT-DRAGON Score and a Reduced Features Set. Front Neurol. 2020 Jul 31;11:718. doi: 10.3389/fneur.2020.00718. eCollection 2020.
PubMed 32849196
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Care of Stroke in the Hospital of Genk: Outcome After Treatment and the Health-economic Impact of Stroke in the Patient Population
- ClinicalTrials.gov ID
- NCT03355690
- Acronym / sponsor ID
- Stroke / B371201733371/I/U
- Conditions
- Stroke
- Keywords
- thrombectomy, thrombolysis, Health-economic status, Outcome after stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 564 participants (actual)
- Lead sponsor
- Ziekenhuis Oost-LimburgUniversity, hospital or other
- Study start
- 15 Dec 2017 (actual)
- Primary completion
- 15 Dec 2019 (actual)
- Study completion
- 15 Dec 2019 (actual)
- First posted
- 28 Nov 2017 (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.
A stroke occurs when the blood circulation is hampered due an ischemic or hemorrhagic event. Previous, a stroke was treated only with anti-aggregation. Over time, multiple studies have showed a positive effect of intravenous thrombolysis with rt-PA (recombinant tissue plasminogen activator) in comparison with the standard treatment (anti-aggregation). Since 2015, thrombectomy was proven to have an added value in combination with thrombolysis. Thrombectomy is an endovascular technique where the thrombus is removed or fragmented.
Diagnosis and treatment of stroke will have a significant impact on the health-economic status of the patient. However, little data is known. Unfortunately, the outcome after diagnosis with a stroke is not well documented. Therefore, this follow-up study over a time period of one year, will give us a sufficient amount of data to evaluate patients diagnosed with a stroke in the hospital of Genk.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stroke patients | – | –Stroke patients are treated according to the clinical practice which can be divided into: anti-aggregation, thrombectomy and/or thrombolysis |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients (older than 18 years) diagnosed with stroke will be asked to parcipate. When the patient is not approachable for participation, the next of kin will be informed. An informed consent has to be obtained before study participation.
Key inclusion criteria (3 listed)
- signed informed consent
- older than 18 years
- diagnosed with stroke
Key exclusion criteria (1 listed)
- younger than 18 years
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
Modified rankin scale
Time frame: day 1, 3 months and 12 months
Change in modified rankin scale over time: baseline (diagnosis stroke), 3 months and one year follow-up. Modified rankin scale is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke. The scale runs from 0-6, running from perfect health without symptoms to death. 0 - No symptoms. 1. - No significant disability. Able to carry out all usual activities, despite some symptoms. 2. - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3. - Moderate disability. Requires some help, but able to walk unassisted. 4. - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5. - Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6. - Dead.
8 secondary outcomes
Rehabilitation: evaluation muscle strength
Time frame: day 1, 3 months and 12 months
Rehabilitation: evaluation arm/hand function
Time frame: day 1, 3 months and 12 months
Rehabilitation: walking capability
Time frame: day 1, 3 months and 12 months
Rehabilitation: trunk control test
Time frame: day 1, 3 months and 12 months
National Institutes of Health Stroke Scale (NIHSS)
Time frame: day 1, 3 months and 12 months
Quality of life-EQ5D
Time frame: day 1, 3 months and 12 months
Quality of life-Barthel index
Time frame: day 1, 3 months and 12 months
Quality of life-stroke specific quality of life scale
Time frame: day 1, 3 months and 12 months
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 18 Apr 2023.
- Derived from this study: PubMed 32849196Lesenne A, Grieten J, Ernon L, Wibail A, Stockx L, Wouters PF, Dreesen L, Vandermeulen E, Van Boxstael S, Vanelderen P, Van Poucke S, Vundelinckx J, Van Cauter S, Mesotten D. Prediction of Functional Outcome After Acute Ischemic Stroke: Comparison of the CT-DRAGON Score and a Reduced Features Set. Front Neurol. 2020 Jul 31;11:718. doi: 10.3389/fneur.2020.00718. eCollection 2020.
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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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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.
Sofie Vancauter, MD PhD principal investigator
Ziekenhuis Oost-Limburg
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, run by Ziekenhuis Oost-Limburg at 1 site in Belgium.
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 3 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 18 Apr 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 Belgium. 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?
Modified rankin scale (time frame: day 1, 3 months and 12 months). 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 NCT03355690, 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 18 Apr 2023.