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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05706818
Other study ID # GO 19/1039
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 20, 2019
Est. completion date March 27, 2022

Study information

Verified date January 2023
Source Hacettepe University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 90
Est. completion date March 27, 2022
Est. primary completion date April 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Validity and reliability study
Validity and reliability assessment of the Community Integration Questionnaire-revised

Locations

Country Name City State
Turkey Hacettepe University Ankara

Sponsors (1)

Lead Sponsor Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Bumin G, Bayramlar K, Yakut Y, Sener GY. Cross cultural adaptation and reliability of the Turkish version of Amputee Body Image Scale (ABIS). J Back Musculoskelet Rehabil. 2009;22(1):11-6. doi: 10.3233/BMR-2009-0208. — View Citation

Callaway L, Winkler D, Tippett A, Herd N, Migliorini C, Willer B. The Community Integration Questionnaire - Revised: Australian normative data and measurement of electronic social networking. Aust Occup Ther J. 2016 Jun;63(3):143-53. doi: 10.1111/1440-1630.12284. Epub 2016 Apr 13. — View Citation

Topuz S, Ulger O, Yakut Y, Gul Sener F. Reliability and construct validity of the Turkish version of the Trinity Amputation and Prosthetic Experience Scales (TAPES) in lower limb amputees. Prosthet Orthot Int. 2011 Jun;35(2):201-6. doi: 10.1177/0309364611407678. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary The Community Integration Questionnaire-Revised 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
Primary The Community Integration Questionnaire-Revised 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
Primary Trinity Amputation and Prosthesis Experience Scales 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
Primary The Amputee Body Image Scale 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
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