- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04898959
Psychometric Evaluation of the Arabic Activity-specific Balance Confidence (A-ABC) and the Arabic Prosthetic Mobility Questionnaire (PMQ)
January 19, 2022 updated by: Marmara University
Psychometric Evaluation of the Arabic Activity-specific Balance Confidence (A-ABC) and the Arabic Prosthetic Mobility Questionnaire (PMQ) in Saudi Lower Amputees
The primary aim of this study is to perform perform a psychometric analysis of Arabic Activity-specific Balance Confidence (A-ABC) and the Arabic Prosthetic Mobility Questionnaire (A-PMQ) through a modern psychometric approach involving Rasch analysis (RA) to enable its use among Arabic speaking population and to enhance confidence in its use patients with lower limb amputation.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
-
-
-
Istanbul, Turkey, 34000
- Marmara 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 and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Unilateral lower limb amputees (above ankle dezarticulation level)
Description
Inclusion Criteria:
- current users of lower limb prosthesis of minum 6 month,
- to be able to fully understand and appropriately complete the questionnaire,
- to be unilater amputee.
Exclusion Criteria:
- inability to understand and complete the questionnair (e.g. cognitive or language impairment; not native-Arabic speaker),
- less the 6 month of using the prosthesis,
- bilateral and partial lower limb amputees
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Group 1
Lower extremity amputees
|
Filling out the Arabic Activity Specific Balance Confidence (A-ABC) and the Arabic Prosthetic Mobility Questionnaire twice at 2-3 week intervals
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rasch analysis
Time Frame: Change from baseline answers of questions following 3 weeks
|
to perform a psychometric analysis of Arabic Activity-specific Balance Confidence (A-ABC) and the Arabic Prosthetic Mobility Questionnaire (A-PMQ) through a modern psychometric approach involving Rasch analysis
|
Change from baseline answers of questions following 3 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
- Franchignoni F, Monticone M, Giordano A, Rocca B. Rasch validation of the Prosthetic Mobility Questionnaire: A new outcome measure for assessing mobility in people with lower limb amputation. J Rehabil Med. 2015 May;47(5):460-5. doi: 10.2340/16501977-1954.
- Alghwiri AA, Alghadir AH, Al-Momani MO, Whitney SL. The activities-specific balance confidence scale and berg balance scale: Reliability and validity in Arabic-speaking vestibular patients. J Vestib Res. 2016;25(5-6):253-9. doi: 10.3233/VES-160568.
- Alghwiri AA, Khalil H, Al-Sharman A, El-Salem K. Psychometric properties of the Arabic Activities-specific Balance Confidence scale in people with multiple sclerosis: Reliability, validity, and minimal detectable change. NeuroRehabilitation. 2020;46(1):119-125. doi: 10.3233/NRE-192900.
- Elboim-Gabyzon M, Agmon M, Azaiza F. Psychometric properties of the Arabic version of the Activities-Specific Balance Confidence (ABC) scale in ambulatory, community-dwelling, elderly people. Clin Interv Aging. 2019 Jun 18;14:1075-1084. doi: 10.2147/CIA.S194777. eCollection 2019.
- Burger H, Giordano A, Bavec A, Franchignoni F. The Prosthetic Mobility Questionnaire, a tool for assessing mobility in people with lower-limb amputation: validation of PMQ 2.0 in Slovenia. Int J Rehabil Res. 2019 Sep;42(3):263-269. doi: 10.1097/MRR.0000000000000354.
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)
May 5, 2021
Primary Completion (Actual)
November 1, 2021
Study Completion (Actual)
November 11, 2021
Study Registration Dates
First Submitted
May 19, 2021
First Submitted That Met QC Criteria
May 19, 2021
First Posted (Actual)
May 24, 2021
Study Record Updates
Last Update Posted (Actual)
January 21, 2022
Last Update Submitted That Met QC Criteria
January 19, 2022
Last Verified
May 1, 2021
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 09.2021.575
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
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 Filling Out Questionnaires
-
Mansoura UniversityCompletedImmediate Implant Placement | Gap Filling With e-PRF | Gap Filling With AllograftEgypt
-
SMG-SNU Boramae Medical CenterNot yet recruitingStomach Filling
-
Hadassah Medical OrganizationUnknownDental Carious | Dental FillingIsrael
-
Selcuk UniversityEnrolling by invitationEducation | QuestionnairesTurkey (Türkiye)
-
NORCE Norwegian Research Centre ASHordaland County CouncilCompletedDental Polymer Based Filling MaterialNorway
-
Centre Hospitalier Metropole SavoieRecruitingRespiration, Artificial | Echocardiography | Vascular FillingFrance
-
Sheba Medical CenterRecruitingData Collection | QuestionnairesIsrael
-
Ernesta AukštuolytėEnrolling by invitationValidation | QuestionnairesLithuania
-
Isparta University of Applied SciencesThe Scientific and Technological Research Council of Turkey; Suleyman Demirel...CompletedEducational Problems | Surveys and QuestionnairesTurkey (Türkiye)
-
Future University in EgyptRecruitingOral Health | Surveys and QuestionnairesEgypt
Clinical Trials on Filling out Questionaire
-
University of RzeszowCompletedSpine Osteoarthritis | Spa ResortsPoland
-
Kocaeli UniversityCompleted
-
Maastricht University Medical CenterCompletedOveractive Bladder | Non Obstructive Urinary RetentionNetherlands
-
Shenyang Northern HospitalRecruitingCoronary Heart Disease | Cardiac RehabilitationChina
-
Massachusetts General HospitalSamsung ElectronicsActive, not recruitingMood Disorders | Major Depressive Disorder | Mental Health IssueUnited States
-
University Hospital, GhentCompleted
-
Istanbul UniversityCompleted
-
Selcuk UniversityCompleted
-
Hellenic Mediterranean UniversityUniversity General Hospital of HeraklionNot yet recruiting
-
Bahceci Health GroupUskudar UniversityUnknownWomen's Quality of Life, Sexual Life and Psychological State in Patients Undergoing Embryo TransfersDepression | Quality of Life | Anxiety State | Infertility, Female | Sexual Function and Fertility DisordersTurkey