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NCT Number: NCT07504848

Stroke Mobility and Caregiver Outcomes

This study was designed to determine the effect of functional mobility levels of stroke patients on caregiver burden, anxiety, and depression in their caregivers.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Caregiver Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • Scoring ≥24 on the Standardized Mini-Mental State Examination (SMMT) or MMSE-E

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. Brunnstrom Stages of Hemiplegic Recovery

    Time frame: Baseline

  2. 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.

  3. 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.

  4. Burden Interview

    Time frame: Baseline

  5. Timed Up and Go Test

    Time frame: Baseline

  6. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Seda Nur Kemer, PhD

CONTACT

[email protected]

+903623121919

Sponsors and collaborators

Lead sponsor

Ondokuz Mayıs University

Other

Registry information

Official study title

The Effect of Mobility Level in Stroke Patients on Anxiety, Depression, and Caregiver Burden in Caregivers

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 1, 2026
Registry last updated
Apr 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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