- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05706818
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
Intervention / Treatment
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.
Sponsor
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.
General Publications
- 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.
- 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.
- 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.
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
Other Study ID Numbers
- GO 19/1039
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.
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