Validity and Reliability of the Community Integration Questionnaire-Revised in Lower Limb Amputees

January 30, 2023 updated by: Serdar Y ESEN, Hacettepe University

Validity and Reliability of the Turkish Version of the Community Integration Questionnaire-Revised (CIQ-R) in Lower Limb Amputees

The goal of this clinical trial is to determine the validity and reliability of the Community Integration Questionnaire-Revised (CIQ-R) scale in lower limb amputees. The main questions it aims to answer are:

  • The Turkish version of the Community Integration Questionnaire-Revised is valid for lower extremity amputees.
  • The Turkish version of the Community Integration Questionnaire-Revised is reliable for lower extremity amputees.

Participants will:

• Fill out general information, CIQ-R, TAPES, and ABIS forms.

Study Overview

Status

Completed

Conditions

Detailed Description

The aim of this study is to determine the validity and reliability of the Community Integration Questionnaire-Revised (CIQ-R) scale in lower limb amputees. Lower limb amputees aged 18-65 years who used prostheses for at least 6 months and volunteered to participate in the study were included in the study. The adaptation of amputees to prostheses was evaluated with the "Trinity Amputation and Prosthesis Experience Scale" (TAPES), their perception of physical appearance with the "Amputee Body Image Scale" (ABIS), and their community integration with the CIQ-R. Correlation with TAPES and ABIS and confirmatory factor analysis were performed to determine the construct validity of the CIQ-R scale. The test-retest reliability of the CIQ-R scale was determined by the intraclass correlation coefficient (ICC) method. Internal consistency analysis was evaluated with Cronbach's alpha. 90 amputees were included in the study (mean age: 40.96±12.89 years; BMI: 25.55±5.5 kg/m2). The CIQ-R scale was reapplied to 18 of the participants 1 week later.

Study Type

Observational

Enrollment (Actual)

90

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

      • Ankara, Turkey
        • Hacettepe 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

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Lower extremity amputees between the ages of 18 and 65 with a prosthesis usage period of more than 1 year who can speak and read Turkish.

Description

Inclusion Criteria:

  • Those between the ages of 18 and 65
  • Lower extremity amputation
  • Use of a prosthesis for at least one year
  • Individuals who volunteered to participate in the research.

Exclusion Criteria:

  • Have any known cognitive problems
  • Illiterate individuals were excluded from the study.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Community Integration Questionnaire-Revised
Time Frame: 1st day
The Community Integration Questionnaire-Revised (CIQ-R) is a self-report, standardized instrument designed to assess an individual's degree of community integration. On this multisectional scale, patients get a minimum of 0 points (worst condition) and a maximum of 35 points (best condition).
1st day
The Community Integration Questionnaire-Revised
Time Frame: 5 days later
The Community Integration Questionnaire-Revised (CIQ-R) is a self-report, standardized instrument designed to assess an individual's degree of community integration. On this multisectional scale, patients get a minimum of 0 points (worst condition) and a maximum of 35 points (best condition).
5 days later
Trinity Amputation and Prosthesis Experience Scales
Time Frame: 1st day
The Trinity Amputation and Prosthesis Experience Scales (TAPES) is a self-administered questionnaire that comprises psychosocial adjustment, activity restriction, and prosthetic satisfaction domains, each with three subscales.
1st day
The Amputee Body Image Scale
Time Frame: 1st day
The Amputee Body Image Scale affects the individual's perception of their own physical condition, life satisfaction, and well-being. The ABIS consists of 20 items and is scored on a 5-point Likert scale. Three items (3, 12, and 16) are reverse scored. The total score varies between 20-100. A high score indicates poor body image.
1st day

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Serdar Y ESEN, MSc, Hacettepe 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.

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)

November 20, 2019

Primary Completion (ACTUAL)

April 1, 2021

Study Completion (ACTUAL)

March 27, 2022

Study Registration Dates

First Submitted

January 18, 2023

First Submitted That Met QC Criteria

January 30, 2023

First Posted (ACTUAL)

January 31, 2023

Study Record Updates

Last Update Posted (ACTUAL)

January 31, 2023

Last Update Submitted That Met QC Criteria

January 30, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

Clinical Trials on Amputation

Clinical Trials on Validity and reliability study

Subscribe