StrokeNCT05807269
Prevention and Rehabilitation of Stroke in Uganda
An observational study of Stroke, run by Karolinska Institutet at 2 sites in Uganda.
Trial summary
Stroke is increasing in low-income countries in Africa, and knowledge is lacking on risk factors and how to prevent stroke as well as how to best use the resources for rehabilitation after stroke which are very limited. Knowledge generation within this area is therefore urgently needed. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Stroke
- How many people
- 50 participants
- Where
- 2 sitesUganda
- Study dates
- 1 Nov 2023to 31 Mar 2028
- How long will I take part?
- 2 Years
- 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 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Community sample from Wasiko and Hoima in Uganda
Who may be able to join
- Stroke
- Risk factors for stroke: hypertension, diabetes, HIV, malaria, physical inactivity, obesity
Who cannot join
- Not having had stroke and/or having no risk factor for stroke
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Uganda2 sites, 2 recruiting
- Recruiting
AMBSO, Hoima
Hoima
Conrald Kalibagwa
- Recruiting
AMBSO, Wakiso
Kampala
Conrald Kalibagwa
About this study
Stroke is increasing in low-income countries in Africa, and knowledge is lacking on risk factors and how to prevent stroke as well as how to best use the resources for rehabilitation after stroke which are very limited. Knowledge generation within this area is therefore urgently needed. This collaboration between the research group HELD (Health and Everyday Life among people with neurological Disorders), Karolinska Institutet (KI) and the research surveillant site Africa Medical and Behavioral Sciences Organization (AMBSO) population health surveillance (PHS), will create substantial research opportunities to develop and improve prevention and rehabilitation for stroke, which is in line with the sustainable development goals to reduce the prevalence and mortality rates due to NCDs. AMBSO is collecting data from 17 000 households on many potential risk factors for stroke. Questions about stroke primary and secondary prevention of stroke and impact of stroke or need of rehabilitation could be added to the existing questionnaires such as the validated Ugandan version of the Stroke Impact Scale. This is intended to fulfill the aim of the network which is to increase the knowledge of occurrence and consequences of NCDs with a specific focus on stroke, which will be valuable for the development of preventive healthcare policy documents and guidelines for appropriate prevention strategies and rehabilitation interventions.
Research questions in relation to NCDs with focus on stroke prevention and rehabilitation:
- How many cases (prevalence) are reported in the targeted study sites and what is the mortality rate (incidence) that can specifically relate to stroke?
- How does stroke and other NCDs affect and impact the quality of life for persons living in Uganda?
- Which factors impact the recovery process after stroke?
- What sort of rehabilitation is needed in the study areas for persons affected by stroke? In addition, risk factors of stroke such as diabetes and hypertension will be mapped.
- Conditions
- 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 |
|---|---|---|
| People with stroke | Participants with stroke or risk factors for stroke |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stroke Impact Scale-16
Questionnaire comprising 16 statements concerning perceived impact of stroke. Each item is rated on a scale from 0 (high impact) to 5 (no impact).
Measured: At one assessment point during 2023-2024
Stroke Impact Scale, perceived recovery
Perceived recovery after stroke is rated on a visual analogue scale ranging from 0 (no recovery) to 100 (full recovery).
Measured: At one assessment point during 2023-2024
Secondary outcomes (6)
Life Satisfaction Checklist (LISat-11)
Questionnaire that assesses life satisfaction with one global item "Life as a whole", and 9 domain-specific items. Answering alternatives range from 1 (very dissatisfied) to 6 (very satisfied)
Measured: At one assessment point during 2023-2024
Patient Health Questionnaire-9
Questionnaire with nine items that inquire about the frequency of depressed mood and anhedonia over the past two weeks. Score ranges from 0 (not at all) to 6 (nearly every day) where higher scores indicate higher frequency of depressed mood
Measured: At one assessment point during 2023-2024
Generalized Anxiety Disorder Assessment-7
A questionnaire assessing generalized anxiety disorder. The GAD-7 score is calculated by assigning scores of 0, 1, 2, and 3, to the response categories of 'not at all', 'several days', 'more than half the days', and 'nearly every day', respectively, and adding together the scores for the seven questions.
Measured: At one assessment point during 2023-2024
Health Literacy Questionnaire
Questionnaire that assesses health literacy. The Health Literacy Questionnaire contains 44 items, which are divided into nine areas of health literacy. The first five scales are scored on a 4-point Likert scale (ranging from strongly disagree to disagree, agree, and strongly agree), building part I. The other four scales, representing part II, are scored on a 5-point Likert scale where respondents are asked to rate the level of difficulty in undertaking a task (ranging from cannot do, always difficult, usually difficult, sometime difficult, usually easy, and always easy). Higher scores indicate better health literacy. In total six selected questions from part I and part II are used.
Measured: At one assessment point during 2023-2024
Use of health care services
Six questions on use of healthcare services, and information received on stroke and its consequences.
Measured: At one assessment point during 2023-2024
Question about quality of life
The respondents are asked to rate their quality of life on a on a five-point scale from 1 (very poor) to 5 (very good)
Measured: At one assessment point during 2023-2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2023
- Study start1 Nov 2023
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- 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
- 50 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- The Swedish Research Council
- Responsible party
- Principal investigator, Gunilla Eriksson, Karolinska Institutet
- Investigators
- Gunilla Eriksson, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05807269
- Sponsor's protocol ID
- 2022-04303
- Status last verified
- Aug 2026
- First submitted
- 13 Mar 2023
- Last updated
- 5 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention and Rehabilitation of Stroke in Uganda
- ClinicalTrials.gov ID
- NCT05807269
- Acronym / sponsor ID
- 2022-04303
- Conditions
- Stroke
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- The Swedish Research Council
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 11 Apr 2023 (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 increasing in low-income countries in Africa, and knowledge is lacking on risk factors and how to prevent stroke as well as how to best use the resources for rehabilitation after stroke which are very limited. Knowledge generation within this area is therefore urgently needed. This collaboration between the research group HELD (Health and Everyday Life among people with neurological Disorders), Karolinska Institutet (KI) and the research surveillant site Africa Medical and Behavioral Sciences Organization (AMBSO) population health surveillance (PHS), will create substantial research opportunities to develop and improve prevention and rehabilitation for stroke, which is in line with the sustainable development goals to reduce the prevalence and mortality rates due to NCDs. AMBSO is collecting data from 17 000 households on many potential risk factors for stroke. Questions about stroke primary and secondary prevention of stroke and impact of stroke or need of rehabilitation could be added to the existing questionnaires such as the validated Ugandan version of the Stroke Impact Scale. This is intended to fulfill the aim of the network which is to increase the knowledge of occurrence and consequences of NCDs with a specific focus on stroke, which will be valuable for the development of preventive healthcare policy documents and guidelines for appropriate prevention strategies and rehabilitation interventions.
Research questions in relation to NCDs with focus on stroke prevention and rehabilitation:
- How many cases (prevalence) are reported in the targeted study sites and what is the mortality rate (incidence) that can specifically relate to stroke?
- How does stroke and other NCDs affect and impact the quality of life for persons living in Uganda?
- Which factors impact the recovery process after stroke?
- What sort of rehabilitation is needed in the study areas for persons affected by stroke? In addition, risk factors of stroke such as diabetes and hypertension will be mapped.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| People with stroke | – | –Participants with stroke or risk factors for stroke |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Community sample from Wasiko and Hoima in Uganda
Key inclusion criteria (2 listed)
- Stroke
- Risk factors for stroke: hypertension, diabetes, HIV, malaria, physical inactivity, obesity
Key exclusion criteria (1 listed)
- Not having had stroke and/or having no risk factor for stroke
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
Stroke Impact Scale-16
Time frame: At one assessment point during 2023-2024
Questionnaire comprising 16 statements concerning perceived impact of stroke. Each item is rated on a scale from 0 (high impact) to 5 (no impact).
Stroke Impact Scale, perceived recovery
Time frame: At one assessment point during 2023-2024
Perceived recovery after stroke is rated on a visual analogue scale ranging from 0 (no recovery) to 100 (full recovery).
6 secondary outcomes
Life Satisfaction Checklist (LISat-11)
Time frame: At one assessment point during 2023-2024
Patient Health Questionnaire-9
Time frame: At one assessment point during 2023-2024
Generalized Anxiety Disorder Assessment-7
Time frame: At one assessment point during 2023-2024
Health Literacy Questionnaire
Time frame: At one assessment point during 2023-2024
Use of health care services
Time frame: At one assessment point during 2023-2024
Question about quality of life
Time frame: At one assessment point during 2023-2024
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 5 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Stroke
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Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
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ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
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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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Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
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Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
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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.
Gunilla Eriksson, PhD principal investigator
Karolinska Institutet
2 sites 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 Karolinska Institutet at 2 sites in Uganda.
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 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: looking for participants now, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Uganda. 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 Gunilla Eriksson, PhD (+46702216924, gunilla.eriksson@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stroke Impact Scale-16 (time frame: At one assessment point during 2023-2024). 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?
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 5 Aug 2026.