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The Care of Stroke in Ziekenhuis Oost-Limburg

The Care of Stroke in the Hospital of Genk: Outcome After Treatment and the Health-economic Impact of Stroke in the Patient Population

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03355690
Acronym
Stroke
Enrollment
564
Registered
2017-11-28
Start date
2017-12-15
Completion date
2019-12-15
Last updated
2023-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

thrombectomy, thrombolysis, Health-economic status, Outcome after stroke

Brief 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 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.

Interventions

None listed

Sponsors

Ziekenhuis Oost-Limburg
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 110 Years
Healthy volunteers
No

Inclusion criteria

* signed informed consent * older than 18 years * diagnosed with stroke

Exclusion criteria

* younger than 18 years

Design outcomes

Primary

MeasureTime frameDescription
Modified rankin scaleday 1, 3 months and 12 monthsChange 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.

Secondary

MeasureTime frameDescription
Quality of life-Barthel indexday 1, 3 months and 12 monthsChange 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.
Rehabilitation: evaluation arm/hand functionday 1, 3 months and 12 monthsChange 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.
Rehabilitation: walking capabilityday 1, 3 months and 12 monthsChange 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.
Rehabilitation: evaluation muscle strengthday 1, 3 months and 12 monthsChange 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.
National Institutes of Health Stroke Scale (NIHSS)day 1, 3 months and 12 monthsChange 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.
Quality of life-EQ5Dday 1, 3 months and 12 monthsChange 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.
Quality of life-stroke specific quality of life scaleday 1, 3 months and 12 monthsChange 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.
Rehabilitation: trunk control testday 1, 3 months and 12 monthsChange 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.

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026