Filling Out QuestionnairesNCT04898959
Psychometric Evaluation of the Arabic Activity-specific Balance Confidence (A-ABC) and the Arabic Prosthetic Mobility Questionnaire (PMQ)
An observational study of Filling Out Questionnaires, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Filling Out Questionnaires
- What is being tested?
- Filling out Questionaire
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 May 2021to 11 Nov 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Unilateral lower limb amputees (above ankle dezarticulation level)
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Filling Out Questionnaires
- Being tested
- Filling out Questionaire
- Keywords
- Arabic Activity-specific Balance Confidence, Arabic Prosthetic Mobility Questionnaire, Psychometric
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Filling out QuestionaireOther
Filling out the Arabic Activity Specific Balance Confidence (A-ABC) and the Arabic Prosthetic Mobility Questionnaire twice at 2-3 week intervals
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Lower extremity amputees Receives: Other: Filling out Questionaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rasch analysis
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
Measured: Change from baseline answers of questions following 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2021
- Study start5 May 2021
- Primary completion1 Nov 2021
- Study completion11 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Filling Out QuestionnairesStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04898959
- Sponsor's protocol ID
- 09.2021.575
- Status last verified
- May 2021
- First submitted
- 19 May 2021
- Last updated
- 21 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 25783231Alghwiri 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.
PubMed 26890426Alghwiri 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.
PubMed 32039869Elboim-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.
PubMed 31354251Burger 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.
PubMed 31210649
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychometric Evaluation of the Arabic Activity-specific Balance Confidence (A-ABC) and the Arabic Prosthetic Mobility Questionnaire (PMQ) in Saudi Lower Amputees
- ClinicalTrials.gov ID
- NCT04898959
- Acronym / sponsor ID
- 09.2021.575
- Conditions
- Filling Out Questionnaires
- Keywords
- Arabic Activity-specific Balance Confidence, Arabic Prosthetic Mobility Questionnaire, Psychometric
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 5 May 2021 (actual)
- Primary completion
- 1 Nov 2021 (actual)
- Study completion
- 11 Nov 2021 (actual)
- First posted
- 24 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Other: Filling out QuestionaireLower extremity amputees |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Unilateral lower limb amputees (above ankle dezarticulation level)
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Filling out QuestionaireFilling out the Arabic Activity Specific Balance Confidence (A-ABC) and the Arabic Prosthetic Mobility Questionnaire twice at 2-3 week intervals | Other | Group 1 |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2022.
- Background: PubMed 25783231Franchignoni 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.
- Results publication: PubMed 26890426Alghwiri 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.
- Results publication: PubMed 32039869Alghwiri 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.
- Results publication: PubMed 31354251Elboim-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.
- Results publication: PubMed 31210649Burger 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.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Filling Out Questionnaires, run by Marmara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rasch analysis (time frame: Change from baseline answers of questions following 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04898959, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2022.