Stroke Mobility and Caregiver Outcomes

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: Not yet recruiting
• Conditions: Stroke; Caregiver

• Study Type: Observational
• Enrollment (Estimated): 64

Contacts and Locations

• Study Contact: Name: Seda Nur Kemer, PhD; Phone Number: +903623121919; Email: sedanur.kemer@omu.edu.tr

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Caregivers
Stroke Patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Brunnstrom Stages of Hemiplegic Recovery		Baseline
Burden Interview		Baseline
Timed Up and Go Test		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.	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.	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.	Baseline

Collaborators and Investigators

• Sponsor: Ondokuz Mayıs University

Study record dates

Study Major Dates

• Study Start (Estimated): April 2, 2026
• Primary Completion (Estimated): April 15, 2026
• Study Completion (Estimated): April 15, 2026

Study Registration Dates

• First Submitted: March 26, 2026
• First Submitted That Met QC Criteria: March 26, 2026
• First Posted (Actual): April 1, 2026

Study Record Updates

• Last Update Posted (Actual): April 6, 2026
• Last Update Submitted That Met QC Criteria: March 31, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke
• Other Study ID 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