StrokeNCT07253519
The Relationship Between Mood and Insomnia Severity and Caregiver Burden in Caregivers of Stroke
An observational study of Stroke, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study will include stroke patients aged 18-80 years and their caregivers. Demographic data such as age, height, weight, and comorbidities will be recorded, along with stroke-specific characteristics including duration of stroke, affected side, lesion location, and etiology. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Nov 2025to 30 Nov 2025
- How long will I take part?
- 1 Day
- 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 80 years
- All sexes
- Adult, Older adult
Study population: stroke
Who may be able to join
- Age 18-80 years.
- Clinical diagnosis of stroke (ischemic or hemorrhagic; first-ever or recurrent).
- Ability of both the patient and caregiver to communicate in Turkish and participate in evaluations (mRS, Brunnstrom, Modified Barthel Index, Holden).
- Caregiver must have been the primary caregiver for the patient for at least 1 month.
- Willingness of both the patient and caregiver to participate in the study.
Who cannot join
- History of subarachnoid hemorrhage.
- Inability to communicate effectively due to severe aphasia or severe cognitive impairment.
- Terminal illness (life expectancy < 6 months).
- Inability to reliably complete questionnaires due to a psychiatric disorder.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Istanbul
About this study
Official title: The Relationship Between Mood and Insomnia Severity and Caregiver Burden in Caregivers of Stroke Patients
This study will include stroke patients aged 18-80 years and their caregivers. Demographic data such as age, height, weight, and comorbidities will be recorded, along with stroke-specific characteristics including duration of stroke, affected side, lesion location, and etiology. Patients' functional status will be assessed using the Modified Rankin Scale, Brunnstrom Stages, and the Modified Barthel Index, while ambulation status will be documented with the Holden Scale. Caregivers will complete the Insomnia Severity Index to assess the severity of sleep disturbances and the Hospital Anxiety and Depression Scale to evaluate anxiety and depressive symptoms. Caregiver burden will be measured using the Zarit Caregiver Burden Scale. The study aims to investigate the relationship between caregivers' mood, insomnia severity, and caregiver burden.
- Conditions
- Stroke
- Being tested
- no intervention
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Zarit Caregiver Burden Scale (ZCBS)
Measures the perceived caregiver burden related to physical, emotional, social, and financial strain.
Score Range: 0-88
Higher scores indicate higher caregiver burden.
Measured: Baseline
Secondary outcomes (6)
Insomnia Severity Index (ISI)
Assesses the severity of insomnia symptoms experienced by caregivers. Score Range: 0-28
Higher scores indicate more severe insomnia.
Measured: Baseline
Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A)
Evaluates the presence and severity of anxiety symptoms in caregivers. Score Range: 0-21
Higher scores indicate more severe anxiety.
Measured: Baseline
Hospital Anxiety and Depression Scale - Depression Subscale (HADS-D)
Assesses depressive symptom severity in caregivers. Score Range: 0-21
Higher scores indicate more severe depression.
Measured: Baseline
Modified Rankin Scale (mRS)
Clinician-rated scale assessing global disability in stroke patients. Score Range: 0-6
Higher scores indicate greater disability.
Measured: Baseline
Modified Barthel Index (MBI)
Measures independence in activities of daily living. Score Range: 0-100
Higher scores indicate greater independence.
Measured: Baseline
Holden Functional Ambulation Classification (FAC)
Evaluates ambulation ability and level of assistance required. Score Range: 0-5
Higher scores indicate more independent walking.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2025
- Study start20 Nov 2025 (estimated)
- Primary completion30 Nov 2025 (estimated)
- Study completion30 Nov 2025 (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.
- 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
- Cross-sectional
- Enrolment
- 100 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07253519
- Sponsor's protocol ID
- istftrrrr
- Status last verified
- Nov 2025
- First submitted
- 19 Nov 2025
- Last updated
- 28 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Mood and Insomnia Severity and Caregiver Burden in Caregivers of Stroke Patients
- ClinicalTrials.gov ID
- NCT07253519
- Acronym / sponsor ID
- istftrrrr
- Conditions
- Stroke
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research HospitalOther government
- Study start
- 20 Nov 2025 (estimated)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 28 Nov 2025 (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.
This study will include stroke patients aged 18-80 years and their caregivers. Demographic data such as age, height, weight, and comorbidities will be recorded, along with stroke-specific characteristics including duration of stroke, affected side, lesion location, and etiology. Patients' functional status will be assessed using the Modified Rankin Scale, Brunnstrom Stages, and the Modified Barthel Index, while ambulation status will be documented with the Holden Scale. Caregivers will complete the Insomnia Severity Index to assess the severity of sleep disturbances and the Hospital Anxiety and Depression Scale to evaluate anxiety and depressive symptoms. Caregiver burden will be measured using the Zarit Caregiver Burden Scale. The study aims to investigate the relationship between caregivers' mood, insomnia severity, and caregiver burden.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- stroke
Key inclusion criteria (5 listed)
- Age 18-80 years.
- Clinical diagnosis of stroke (ischemic or hemorrhagic; first-ever or recurrent).
- Ability of both the patient and caregiver to communicate in Turkish and participate in evaluations (mRS, Brunnstrom, Modified Barthel Index, Holden).
- Caregiver must have been the primary caregiver for the patient for at least 1 month.
- Willingness of both the patient and caregiver to participate in the study.
Key exclusion criteria (4 listed)
- History of subarachnoid hemorrhage.
- Inability to communicate effectively due to severe aphasia or severe cognitive impairment.
- Terminal illness (life expectancy < 6 months).
- Inability to reliably complete questionnaires due to a psychiatric disorder.
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 |
|---|---|---|
| no interventionno intervention | Other | – |
Primary outcome
Zarit Caregiver Burden Scale (ZCBS)
Time frame: Baseline
Measures the perceived caregiver burden related to physical, emotional, social, and financial strain. Score Range: 0-88 Higher scores indicate higher caregiver burden.
6 secondary outcomes
Insomnia Severity Index (ISI)
Time frame: Baseline
Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A)
Time frame: Baseline
Hospital Anxiety and Depression Scale - Depression Subscale (HADS-D)
Time frame: Baseline
Modified Rankin Scale (mRS)
Time frame: Baseline
Modified Barthel Index (MBI)
Time frame: Baseline
Holden Functional Ambulation Classification (FAC)
Time frame: Baseline
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 28 Nov 2025.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Istanbul Physical Medicine Rehabilitation Training and Research Hospital at 1 site in Turkey (Türkiye).
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 5 inclusion and 4 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: opening soon, as of the sponsor's last update on 28 Nov 2025. 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 Turkey (Türkiye). 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?
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?
Zarit Caregiver Burden Scale (ZCBS) (time frame: Baseline). 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 28 Nov 2025.