Stroke Mobility and Caregiver Outcomes

NCT07504848 | Not Yet Recruiting

• 1 other identifier: 2025/105
• Study Type: observational
• Target: 64
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Stroke; Caregiver

Outcome Measures

Primary Outcomes (6)

• Brunnstrom Stages of Hemiplegic Recovery

  Baseline

• Beck Depression Inventory

  Baseline

• Beck Anxiety Inventory

  Baseline

• Burden Interview

  Baseline

• Timed Up and Go Test

  Baseline

• Rivermead Mobility Index

  Baseline

Study Arms (2)

Stroke Patients

Caregivers

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Ondokuz Mayıs University: lead

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Seda Nur Kemer, PhD

CONTACT

+903623121919; sedanur.kemer@omu.edu.tr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer, PhD

Study Record Dates

• First Submitted: March 26, 2026
• First Posted: April 1, 2026
• Study Start: April 2, 2026
• Primary Completion: April 15, 2026
• Study Completion: April 15, 2026
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share