HemiplegiaNCT06457061
Evaluation of Caregiver Burden and Depression Severity in Patients With Hemiplegia
An observational study of Hemiplegia and Caregiver Burden, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to evaluate the caregiving burden and severity of depression in patients with right hemiplegia and left hemiplegia. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hemiplegia, Caregiver Burden, Depression
- What is being tested?
- Survey Study
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2023to 1 May 2024
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hemiplegia patients treated in our outpatient and inpatient physical therapy and rehabilitation units and their first- or second-degree relatives who care for these patients constitute the study population.
Who may be able to join
- Hemiplegia patients between the ages of 18 and 75 were included.
- Caregivers over 18 years of age
- At least 3 months must have passed since the patient was diagnosed.
- Caregivers of patients should be their first and second degree relatives.
- Caregivers must be competent to understand what they read and complete the questionnaires.
- Caregivers must have been caring for their patients for at least 3 months.
Who cannot join
- Patients and caregivers with a history of psychiatric illness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Caregiver Burden and Depression Severity in Patients With Right and Left Hemiplegia
This study aimed to evaluate the caregiving burden and severity of depression in patients with right hemiplegia and left hemiplegia.
Read the detailed description
Stroke is a disease characterized by neurological symptoms and signs lasting more than 24 hours, which can lead to death after the interruption of brain blood flow or due to focal brain damage. Post-stroke disability affects the patient's quality of life, makes the patient dependent on the caregiver, creates a caregiver burden, and brings socioeconomic and social consequences. Different hemispheres of the brain undertake different tasks. Different clinical conditions may occur in stroke patients with right or left hemiplegia following cerebrovascular infarction. This may affect the care burden of caregivers and the severity of depression. It was thought that knowing the care burden of patients with right and left hemiplegia would positively contribute to the quality of care given to patients.This study aimed to evaluate the caregiving burden and severity of depression in patients with right hemiplegia and left hemiplegia.
- Conditions
- Hemiplegia, Caregiver Burden, Depression
- Being tested
- Survey Study
- Medical subject headings
- Hemiplegia, Caregiver Burden, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Survey StudyOther
Barthel Index for Activities of Daily Living Scale, Beck Depression Inventory and Star Cancellation Test questionnaires were applied to hemiplegia patients.
Beck Depression Inventory and Zarit Caregiver Burden Interview surveys were administered to caregivers.
| Study group | Role | What they receive |
|---|---|---|
| Right Hemiplegia | Not described Receives: Other: Survey Study | |
| Left Hemiplegia | Not described Receives: Other: Survey Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beck's Depression Inventory
The Beck Depression Inventory (BDI) is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression. The score to be received varies between 0-63. A high total score indicates a higher severity of depression.
Measured: Day 1
Zarit Caregiver Burden
Zarit caregiver burden interview evaluates caregivers' caregiving burden. It consists of 22 questions. A minimum of 0 and a maximum of 88 points can be obtained from the scale. A A high total score indicates a higher severity of caregiver burden
Measured: Day 1
Secondary outcomes (2)
Barthel Index for Activities of Daily Living Scale
The Barthel index is used to assess activities of daily living. It consists of 10 items: feeding, bathing, grooming, dressing, bowel, bladder, toilet use, transfers, mobility, stairs. Scores range from 0-100. A score of 100 represents complete independence, and a score of 0 represents complete dependence.
Measured: Day 1
Star Cancellation test
The Star Cancellation Test is a screening tool developed to detect the presence of unilateral spatial neglect
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2024
- Study start1 Jun 2023
- Primary completion1 Apr 2024
- Study completion1 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemiplegiaStudies of the same condition, open and under way.
- More trials run by Abant Izzet Baysal UniversityThe 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
- Cross-sectional
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serdar Kilinc, Abant Izzet Baysal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06457061
- Sponsor's protocol ID
- AIBU-FTR-SK-06
- Status last verified
- Jun 2024
- First submitted
- 10 Jun 2024
- Last updated
- 13 Jun 2024
- Results posted
- No
- Data monitoring committee
- 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 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Caregiver Burden and Depression Severity in Patients With Right and Left Hemiplegia
- ClinicalTrials.gov ID
- NCT06457061
- Acronym / sponsor ID
- AIBU-FTR-SK-06
- Conditions
- Hemiplegia, Caregiver Burden, Depression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 13 Jun 2024 (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 aimed to evaluate the caregiving burden and severity of depression in patients with right hemiplegia and left hemiplegia.
Detailed description
Stroke is a disease characterized by neurological symptoms and signs lasting more than 24 hours, which can lead to death after the interruption of brain blood flow or due to focal brain damage. Post-stroke disability affects the patient's quality of life, makes the patient dependent on the caregiver, creates a caregiver burden, and brings socioeconomic and social consequences. Different hemispheres of the brain undertake different tasks. Different clinical conditions may occur in stroke patients with right or left hemiplegia following cerebrovascular infarction. This may affect the care burden of caregivers and the severity of depression. It was thought that knowing the care burden of patients with right and left hemiplegia would positively contribute to the quality of care given to patients.This study aimed to evaluate the caregiving burden and severity of depression in patients with right hemiplegia and left hemiplegia.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Right Hemiplegia | – | Other: Survey Study |
| Left Hemiplegia | – | Other: Survey Study |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hemiplegia patients treated in our outpatient and inpatient physical therapy and rehabilitation units and their first- or second-degree relatives who care for these patients constitute the study population.
Key inclusion criteria (6 listed)
- Hemiplegia patients between the ages of 18 and 75 were included.
- Caregivers over 18 years of age
- At least 3 months must have passed since the patient was diagnosed.
- Caregivers of patients should be their first and second degree relatives.
- Caregivers must be competent to understand what they read and complete the questionnaires.
Key exclusion criteria (1 listed)
- Patients and caregivers with a history of psychiatric illness
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 |
|---|---|---|
| Survey StudyBarthel Index for Activities of Daily Living Scale, Beck Depression Inventory and Star Cancellation Test questionnaires were applied to hemiplegia patients. Beck Depression Inventory and Zarit Caregiver Burden Interview surveys were administered to caregivers. | Other | Left Hemiplegia, Right Hemiplegia |
Primary outcome
Beck's Depression Inventory
Time frame: Day 1
The Beck Depression Inventory (BDI) is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression. The score to be received varies between 0-63. A high total score indicates a higher severity of depression.
Zarit Caregiver Burden
Time frame: Day 1
Zarit caregiver burden interview evaluates caregivers' caregiving burden. It consists of 22 questions. A minimum of 0 and a maximum of 88 points can be obtained from the scale. A A high total score indicates a higher severity of caregiver burden
2 secondary outcomes
Barthel Index for Activities of Daily Living Scale
Time frame: Day 1
Star Cancellation test
Time frame: Day 1
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 13 Jun 2024.
- Individual participant dataSharing planned: No
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Studies of the Variable Phenotypic Presentations of Rapid-Onset Dystonia Parkinsonism and Other Movement Disorders
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Post-Stroke Apraxia, Motor Function, Balance, and Gait
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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.
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 Hemiplegia and Caregiver Burden, run by Abant Izzet Baysal University 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 6 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 13 Jun 2024. 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?
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?
Beck's Depression Inventory (time frame: Day 1). 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 13 Jun 2024; AzTrials last refreshed its copy on 7 Nov 2026.