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Completed

NCT Number: NCT05301946

Application of the ICF Core Set 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.

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Key information

Conditions

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

Age range

25 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Pamukkale University

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

About this study

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.

Who can participate

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

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.

Treatment and study plan

Outcome measurements

Other

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Pamukkale University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Mar 31, 2022
Registry last updated
Apr 8, 2022

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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