Stroke Mobility and Caregiver Outcomes

March 31, 2026 updated by: Seda Nur Kemer, Ondokuz Mayıs University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
64

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  1. 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
    • 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

  2. 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

Exclusion Criteria:

  1. 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
    • 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

  2. 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Caregivers
Stroke Patients

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Brunnstrom Stages of Hemiplegic Recovery
Time Frame: Baseline
Baseline
Burden Interview
Time Frame: Baseline
Baseline
Timed Up and Go Test
Time Frame: Baseline
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.
Baseline
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.
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.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ondokuz Mayıs University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 2, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 15, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 15, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 26, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 26, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 1, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 31, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2025/105

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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