NCT06457061

Brief Summary

This study aimed to evaluate the caregiving burden and severity of depression in patients with right hemiplegia and left hemiplegia.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 10, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 13, 2024

Completed
Last Updated

June 13, 2024

Status Verified

June 1, 2024

Enrollment Period

10 months

First QC Date

June 10, 2024

Last Update Submit

June 12, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Beck's Depression Inventory

    The Beck Depression Inventory (BDI) is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression. The score to be received varies between 0-63. A high total score indicates a higher severity of depression.

    Day 1

  • Zarit Caregiver Burden

    Zarit caregiver burden interview evaluates caregivers' caregiving burden. It consists of 22 questions. A minimum of 0 and a maximum of 88 points can be obtained from the scale. A A high total score indicates a higher severity of caregiver burden

    Day 1

Secondary Outcomes (2)

  • Barthel Index for Activities of Daily Living Scale

    Day 1

  • Star Cancellation test

    Day 1

Study Arms (2)

Right Hemiplegia

Other: Survey Study

Left Hemiplegia

Other: Survey Study

Interventions

Barthel Index for Activities of Daily Living Scale, Beck Depression Inventory and Star Cancellation Test questionnaires were applied to hemiplegia patients. Beck Depression Inventory and Zarit Caregiver Burden Interview surveys were administered to caregivers.

Left HemiplegiaRight Hemiplegia

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Hemiplegia patients treated in our outpatient and inpatient physical therapy and rehabilitation units and their first- or second-degree relatives who care for these patients constitute the study population.

You may qualify if:

  • Hemiplegia patients between the ages of 18 and 75 were included.
  • Caregivers over 18 years of age
  • At least 3 months must have passed since the patient was diagnosed.
  • Caregivers of patients should be their first and second degree relatives.
  • Caregivers must be competent to understand what they read and complete the questionnaires.
  • Caregivers must have been caring for their patients for at least 3 months.

You may not qualify if:

  • Patients and caregivers with a history of psychiatric illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Abant Izzet Baysal University

Bolu, 14100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

HemiplegiaCaregiver BurdenDepression

Interventions

Longitudinal Studies

Condition Hierarchy (Ancestors)

ParalysisNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsStress, PsychologicalBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Cohort StudiesEpidemiologic StudiesEpidemiologic Study CharacteristicsEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

June 10, 2024

First Posted

June 13, 2024

Study Start

June 1, 2023

Primary Completion

April 1, 2024

Study Completion

May 1, 2024

Last Updated

June 13, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations