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

Sponsor
Hacettepe University (Other)
Overall Status
Completed
CT.gov ID
NCT05706818
Collaborator
(none)
90
1
28.2
3.2

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Validity and reliability study

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 Design

Study Type:
Observational
Actual Enrollment :
90 participants
Observational Model:
Case-Only
Time Perspective:
Cross-Sectional
Official Title:
Validity and Reliability of the Turkish Version of the Community Integration Questionnaire-Revised (CIQ-R) in Lower Limb Amputees
Actual Study Start Date :
Nov 20, 2019
Actual Primary Completion Date :
Apr 1, 2021
Actual Study Completion Date :
Mar 27, 2022

Outcome Measures

Primary Outcome Measures

  1. The Community Integration Questionnaire-Revised [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).

  2. The Community Integration Questionnaire-Revised [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).

  3. Trinity Amputation and Prosthesis Experience Scales [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.

  4. The Amputee Body Image Scale [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hacettepe University Ankara Turkey

Sponsors and Collaborators

  • Hacettepe University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Serdar Y ESEN, Pirincipal investigator, Hacettepe University
ClinicalTrials.gov Identifier:
NCT05706818
Other Study ID Numbers:
  • GO 19/1039
First Posted:
Jan 31, 2023
Last Update Posted:
Jan 31, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Serdar Y ESEN, Pirincipal investigator, Hacettepe University

Study Results

No Results Posted as of Jan 31, 2023