NCT05706818

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 20, 2019

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 27, 2022

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 18, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 31, 2023

Completed
Last Updated

January 31, 2023

Status Verified

January 1, 2023

Enrollment Period

1.4 years

First QC Date

January 18, 2023

Last Update Submit

January 30, 2023

Conditions

Keywords

lower limb amputeescommunity integrationsocial participationvalidityreliability

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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

Interventions

Validity and reliability assessment of the Community Integration Questionnaire-revised

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Ankara, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

    PMID: 27072343BACKGROUND
  • 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.

    PMID: 21697202BACKGROUND
  • 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.

    PMID: 20023358BACKGROUND

Study Officials

  • Serdar Y ESEN, MSc

    Hacettepe University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pirincipal investigator

Study Record Dates

First Submitted

January 18, 2023

First Posted

January 31, 2023

Study Start

November 20, 2019

Primary Completion

April 1, 2021

Study Completion

March 27, 2022

Last Updated

January 31, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations