StrokeNCT07504848
Stroke Mobility and Caregiver Outcomes
An observational study of Stroke and Caregiver, run by Ondokuz Mayıs University.
Trial summary
This study was designed to determine the effect of functional mobility levels of stroke patients on caregiver burden, anxiety, and depression in their caregivers. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- 2 Apr 2026to 15 Apr 2026
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This study includes adult individuals with a first-ever unilateral stroke and their primary caregivers. Stroke patients aged 18-75 years, at least 3 months post-stroke, with sufficient cognitive function (MMSE ≥24), and stable medical status are included. Caregivers are adults who have been living with the patient for at least one year and are the primary, non-professional caregivers.
Who may be able to join
- Stroke Patients:
- Diagnosed with stroke according to WHO criteria (≥20% disability rate documented in Adult Disability Health Board Report)
- Having a family member or relative who provides care
- First-ever and unilateral stroke
- Willing to participate voluntarily
- Aged between 18-75 years
Show all 16Show fewer
- Post-stroke duration longer than 3 months
- Stable vital signs
- Scoring ≥24 on the Standardized Mini-Mental State Examination (SMMT) or the -Modified Mini-Mental State Examination for Illiterate Individuals (MMSE-E)
- Able to understand and speak Turkish
- Caregivers of Stroke Patients:
- Willing to participate in the study
- Living with the patient for at least 1 year
- Being the primary (main responsible) caregiver and not receiving paid professional caregiving services
- Aged 18 years or older
- Scoring ≥24 on the Standardized Mini-Mental State Examination (SMMT) or MMSE-E
Who cannot join
- Stroke Patients:
- Presence of severe comorbid conditions
- Unwillingness to participate
- History of multiple strokes
- Bilateral hemiplegia
- Presence of major neurological, orthopedic, or rheumatologic disorders affecting the musculoskeletal system other than stroke
Show all 15Show fewer
- Congenital anomalies or amputation causing disability
- Uncontrolled arrhythmia, uncontrolled hypertension, or unstable cardiac conditions
- Botulinum toxin injection within the last 6 months
- Inability to establish cooperation
- Presence of neglect, aphasia, or hemianopsia
- Caregivers of Stroke Patients:
- Unwillingness to participate
- Living with the patient for less than 1 year
- Presence of mental retardation, dementia, or severe psychotic disorders
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Effect of Mobility Level in Stroke Patients on Anxiety, Depression, and Caregiver Burden in Caregivers
This study was designed to determine the effect of functional mobility levels of stroke patients on caregiver burden, anxiety, and depression in their caregivers.
- 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 | Not described | |
| Caregivers | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brunnstrom Stages of Hemiplegic Recovery
Measured: Baseline
Beck Depression Inventory
The Beck Depression Inventory (BDI) is scored between 0 and 63, where 0 indicates minimal or no depressive symptoms and 63 reflects severe depression; increasing scores correspond to greater severity of depressive symptomatology.
Measured: Baseline
Beck Anxiety Inventory
Beck Anxiety Inventory (BAI) ranges from 0 to 63, with 0 indicating minimal anxiety and 63 indicating severe anxiety; higher scores represent increased severity of anxiety symptoms.
Measured: Baseline
Burden Interview
Measured: Baseline
Timed Up and Go Test
Measured: Baseline
Rivermead Mobility Index
The Rivermead Mobility Index (RMI) ranges from 0 to 15. 0 indicates severe dependence with inability to perform basic mobility tasks. 15 indicates full independence in all assessed mobility activities. As the score increases, it reflects a progressive improvement in functional mobility, with greater independence in activities such as transfers, walking, and balance.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2026
- Study start2 Apr 2026 (estimated)
- Primary completion15 Apr 2026 (estimated)
- Study completion15 Apr 2026 (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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seda Nur Kemer, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07504848
- Sponsor's protocol ID
- 2025/105
- Status last verified
- Mar 2026
- First submitted
- 26 Mar 2026
- Last updated
- 6 Apr 2026
- 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 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mobility Level in Stroke Patients on Anxiety, Depression, and Caregiver Burden in Caregivers
- ClinicalTrials.gov ID
- NCT07504848
- Acronym / sponsor ID
- 2025/105
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 2 Apr 2026 (estimated)
- Primary completion
- 15 Apr 2026 (estimated)
- Study completion
- 15 Apr 2026 (estimated)
- First posted
- 1 Apr 2026 (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 was designed to determine the effect of functional mobility levels of stroke patients on caregiver burden, anxiety, and depression in their caregivers.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stroke Patients | – | – |
| Caregivers | – | – |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This study includes adult individuals with a first-ever unilateral stroke and their primary caregivers. Stroke patients aged 18-75 years, at least 3 months post-stroke, with sufficient cognitive function (MMSE ≥24), and stable medical status are included. Caregivers are adults who have been living with the patient for at least one year and are the primary, non-professional caregivers.
Key inclusion criteria (16 listed)
- Stroke Patients:
- Caregivers of Stroke Patients:
Key exclusion criteria (15 listed)
- Stroke Patients:
- Caregivers of Stroke Patients:
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
Brunnstrom Stages of Hemiplegic Recovery
Time frame: Baseline
Beck Depression Inventory
Time frame: Baseline
The Beck Depression Inventory (BDI) is scored between 0 and 63, where 0 indicates minimal or no depressive symptoms and 63 reflects severe depression; increasing scores correspond to greater severity of depressive symptomatology.
Beck Anxiety Inventory
Time frame: Baseline
Beck Anxiety Inventory (BAI) ranges from 0 to 63, with 0 indicating minimal anxiety and 63 indicating severe anxiety; higher scores represent increased severity of anxiety symptoms.
Burden Interview
Time frame: Baseline
Timed Up and Go Test
Time frame: Baseline
Rivermead Mobility Index
Time frame: Baseline
The Rivermead Mobility Index (RMI) ranges from 0 to 15. 0 indicates severe dependence with inability to perform basic mobility tasks. 15 indicates full independence in all assessed mobility activities. As the score increases, it reflects a progressive improvement in functional mobility, with greater independence in activities such as transfers, walking, and balance.
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 6 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Stroke
RecruitingPhase 1/2
Safety and Efficacy of CG-BM1 in Ischemic Stroke
Ischemic Stroke or High-risk TIA (ABCD² ≥ 4)
Not yet recruitingPhase 3
Recombinant Human Prourokinase for Acute Ischemic Stroke in the Extended Window Selected by CT-Based Artificial Intelligence
Acute Ischemic Stroke
Recruiting
Effects of Mirror Therapy and Motor Imagery on Upper Limb Motor Functions in Middle Cerebral Artery Stroke
Stroke
Recruiting
Rapid Local Ischemic Postconditioning on Stroke After Thrombectomy
Acute Ischemic Stroke
Not yet recruitingObservational study
The GEIR Registry: Rationale and Design of the First Nationwide Multicentre Retinal Stroke Registry in Spain
Retinal 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Caregiver, run by Ondokuz Mayıs University.
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 16 inclusion and 15 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 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Seda Nur Kemer, PhD (+903623121919, sedanur.kemer@omu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brunnstrom Stages of Hemiplegic Recovery (time frame: Baseline). The study lists 6 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 6 Apr 2026.