Application of the ICF Core Set in Stroke Patients

March 30, 2022 updated by: Güzin Kara, Pamukkale University

Application of the ICF Core Set for Cognitive Function, Quality of Life and Mobility in Stroke Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Fourty men and twenty women stroke patients were included in this study.The demographics and clinical information of the participants were recorded. A physiotherapist created an ICF Core Set for Stroke for the study. The ICF Core Set for Stroke was used to show the significant relationship with Standardized Mini-Mental State Examination, Stroke Impact Scale Version 3.0, and Rivermead Mobility Index. The duration of the assessment varied between 1 hour and 1.5 hours depending on the participant.

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Kınıklı/Pamukkale
      • Denizli, Kınıklı/Pamukkale, Turkey, 20070
        • Pamukkale University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • . Stroke patients who did not complete the evaluations.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Standardized Mini-Mental State Examination
Time Frame: One year
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
Time Frame: One year
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
Time Frame: One year
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
Time Frame: One year
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
Time Frame: One year
The core set was created and consisted of 24 ICF items. Each category is scored between 0 - 4 and 8, or 9.
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pamukkale University

Investigators

  • Principal Investigator: Güzin Kara, Ph.D., Pamukkale University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 1, 2019

Primary Completion (ACTUAL)

December 28, 2021

Study Completion (ACTUAL)

February 3, 2022

Study Registration Dates

First Submitted

March 21, 2022

First Submitted That Met QC Criteria

March 21, 2022

First Posted (ACTUAL)

March 31, 2022

Study Record Updates

Last Update Posted (ACTUAL)

April 8, 2022

Last Update Submitted That Met QC Criteria

March 30, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 60116787-020/9175

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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