NCT05301946

Brief Summary

Sixty patients with stroke were applied a-24-item ICF Core Set for Stroke, Standardized Mini-Mental State Examination(SMMSE), Stroke Impact Scale Version(SIS), Rivermead Mobility Index(RMI) and Home Safety Checklist(HSCL). Spearman and Pearson correlation analysis was used to show the relation between the items of the scales and the ICF Core Set for Stroke items.

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 Feb 2019

Typical duration 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

February 1, 2019

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 28, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 3, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 21, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 31, 2022

Completed
Last Updated

April 8, 2022

Status Verified

March 1, 2022

Enrollment Period

2.9 years

First QC Date

March 21, 2022

Last Update Submit

March 30, 2022

Conditions

Stroke; Paralysis

Outcome Measures

Primary Outcomes (5)

  • Standardized Mini-Mental State Examination

    This scale was used to assess the cognitive status of stroke patients. The maximum score of SMMSE is 30 points.

    One year

  • Stroke Impact Scale

    This scale was used to assess the quality of life in stroke patients. Each domain is scored from 0 to 100.

    One year

  • Rivermead Mobility Index

    This scale was used to assess the mobility levels of stroke patients. The minimum and maximum scores are between 0-15.

    One year

  • Home Safety Checklist

    Ten items of this scale were used to assess the home safety status. The HSCL is scored between 0-65.

    One year

  • A 24-item ICF Core Set for Stroke

    The core set was created and consisted of 24 ICF items. Each category is scored between 0 - 4 and 8, or 9.

    One year

Study Arms (1)

Stroke patients

The created-ICF Core Set for Stroke including activitiy, participation, and environmental factors was used show the meaningfulness of the clinical outcome measurements. The correlation of the created-ICF Core Set for Stroke's items and the outcome measurements were analyzed through Spearman or Pearson correlation analysis.

Other: Outcome Measurements

Interventions

Outcome MeasurementsOTHER

The 24-item ICF Core Set for Stroke, Standardized Mini-Mental State Examination, Stroke Impact Scale, Rivermead Mobility Index, and Home Safety Checklist were applied to the stroke patients. The assessment period took one hour.

Stroke patients

Eligibility Criteria

Age25 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

40 men, 20 women stroke patients who met the inclusion criteria. were included in the study.

You may qualify if:

  • Being between the ages of 25-80,
  • Having a single stroke,
  • Not having any other condition affecting the evaluation such as aphasia, consciousness disorders, or other neurological diseases.

You may not qualify if:

  • Stroke patients who did not complete the evaluations.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pamukkale University

Denizli, Kınıklı/Pamukkale, 20070, Turkey (Türkiye)

Location

Related Publications (3)

  • Tarvonen-Schroder S, Hurme S, Laimi K. The World Health Organization Disability Assessment Schedule (WHODAS 2.0) and the WHO Minimal Generic Set of Domains of Functioning and Health versus Conventional Instruments in subacute stroke. J Rehabil Med. 2019 Oct 4;51(9):675-682. doi: 10.2340/16501977-2583.

    PMID: 31402390BACKGROUND

  • Sumathipala K, Radcliffe E, Sadler E, Wolfe CD, McKevitt C. Identifying the long-term needs of stroke survivors using the International Classification of Functioning, Disability and Health. Chronic Illn. 2012 Mar;8(1):31-44. doi: 10.1177/1742395311423848. Epub 2011 Oct 24.

    PMID: 22025770BACKGROUND

  • Yarar F, Cavlak U, Basakci Calik B. Applying the International Classification of Functioning, Disability, and Health in children with low vision: differences between raters. Turk J Med Sci. 2016 Dec 20;46(6):1694-1699. doi: 10.3906/sag-1506-152.

    PMID: 28081311BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Güzin Kara, Ph.D.

    Pamukkale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

March 21, 2022

First Posted

March 31, 2022

Study Start

February 1, 2019

Primary Completion

December 28, 2021

Study Completion

February 3, 2022

Last Updated

April 8, 2022

Record last verified: 2022-03

Locations

TU(1)