Old Age; DebilityNCT05058703
Saraiki Translation, Validity & Reliability of the Activities Specific Balance Confidence (ABC) Scale Questionnaire
An observational study of Old Age; Debility, run by Riphah International University at 1 site in Pakistan.
Trial summary
There is a need for a culturally adapted screening tool to aid health care professionals or clinicians screen for the presence of fall and balance issues associated with injuries in saraiki population. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Old Age; Debility
- How many people
- 32 participants
- Where
- 1 sitePakistan
- Study dates
- 26 Jun 2021to 31 Aug 2022
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Older Adults
Who may be able to join
- Able to read saraiki language.
- Healthy older population
- People with controlled Diabetes mellitus
- People with controlled hypertension
- Older adults with BBS score 45-56.
Who cannot join
- Unstable medical condition.
- Cognitive issues like not able to concentrate, can't perform the task attentively.
- Any physical disability like not able to walk and patient with vestibular disorders.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Civil Hospital
Chak Eighty-seven -Twelve Left, Punjab Province
About this study
Official title: Saraiki Translation, Validity & Reliability of the Activities Specific Balance Confidence (ABC) Scale Questionnaire in Older Adults
There is a need for a culturally adapted screening tool to aid health care professionals or clinicians screen for the presence of fall and balance issues associated with injuries in saraiki population. Furthermore, while culturally adapting the scale is necessary, it is important that changes do not alter the original intent, which requires it to be broad, comprehensible and applicable to the entire population. As saraiki language is the most-used language in the South Punjab, translating and adapting the ABC scale to the saraiki population while accounting for its sociocultural characteristics is an important task. So, I decided to conduct a tool translation and validation study. This study will help the clinicians to assess their patient's confidence and balance easily through the saraiki version of ABC scale in saraiki population and hence will help in timely management of the balance.
Read the detailed description
The ABC scale is a 16-item questionnaire with 11-point subscales that assess the level of confidence in performing a specific task without losing balance or becoming unsteady. Each item score ranges from 0% (no confidence) to 100% (total confidence).
As cross-border and cross-cultural studies continue to increase, there is a greater need for linguistic validation of tools across a variety of societies. Until now, no translation or adaptation of the ABC scale has been made for the population with different languages in Pakistan. In order to use questionnaires in areas with different languages and cultures, translation into new languages of ABC scale, for identifying fall and balance issues is required.
- Conditions
- Old Age; Debility
- Keywords
- balance, older adults
- Medical subject headings
- Frailty
What is being measured
The primary outcome is the main question the study is designed to answer.
Saraiki version of Activities-specific Balance Confidence Scale
The ABC scale is a 16-item questionnaire with 11-point subscales that assess the level of confidence in performing a specific task without losing balance or becoming unsteady. Each item score ranges from 0% (no confidence) to 100% (total confidence) and the total score of the S-ABC is obtained by adding up the ratings (0-160) and then dividing by 16
Measured: 1 week
Twelve Item Short Form Health Survey (SF-12)
The 12-item Short Form Health Survey (SF-12) is a multipurpose, generic, 12-item questionnaire developed from the Short Form Health Survey 36 (SF-36). The SF-12 generates a Physical Component Summary scale score (PCS-SF12) and a Mental Component Summary scale score (MCS-SF12). Several studies have reported its validity and reliability as a measure of health-related quality of life in different populations.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2021
- Study start26 Jun 2021
- Primary completion31 Jul 2022
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Old Age; DebilityStudies of the same condition, open and under way.
- More trials run by Riphah International 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
- Other
- Time perspective
- Prospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mirza Obaid Baig, MSPT(NMR), Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05058703
- Sponsor's protocol ID
- REC01038 Farva Ikram
- Status last verified
- Jan 2023
- First submitted
- 17 Sep 2021
- Last updated
- 17 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Saraiki Translation, Validity & Reliability of the Activities Specific Balance Confidence (ABC) Scale Questionnaire in Older Adults
- ClinicalTrials.gov ID
- NCT05058703
- Acronym / sponsor ID
- REC01038 Farva Ikram
- Conditions
- Old Age; Debility
- Keywords
- balance, older adults
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 26 Jun 2021 (actual)
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 28 Sep 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.
There is a need for a culturally adapted screening tool to aid health care professionals or clinicians screen for the presence of fall and balance issues associated with injuries in saraiki population. Furthermore, while culturally adapting the scale is necessary, it is important that changes do not alter the original intent, which requires it to be broad, comprehensible and applicable to the entire population. As saraiki language is the most-used language in the South Punjab, translating and adapting the ABC scale to the saraiki population while accounting for its sociocultural characteristics is an important task. So, I decided to conduct a tool translation and validation study. This study will help the clinicians to assess their patient's confidence and balance easily through the saraiki version of ABC scale in saraiki population and hence will help in timely management of the balance.
Detailed description
The ABC scale is a 16-item questionnaire with 11-point subscales that assess the level of confidence in performing a specific task without losing balance or becoming unsteady. Each item score ranges from 0% (no confidence) to 100% (total confidence).
As cross-border and cross-cultural studies continue to increase, there is a greater need for linguistic validation of tools across a variety of societies. Until now, no translation or adaptation of the ABC scale has been made for the population with different languages in Pakistan. In order to use questionnaires in areas with different languages and cultures, translation into new languages of ABC scale, for identifying fall and balance issues is required.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Older Adults
Key inclusion criteria (5 listed)
- Able to read saraiki language.
- Healthy older population
- People with controlled Diabetes mellitus
- People with controlled hypertension
- Older adults with BBS score 45-56.
Key exclusion criteria (3 listed)
- Unstable medical condition.
- Cognitive issues like not able to concentrate, can't perform the task attentively.
- Any physical disability like not able to walk and patient with vestibular disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Saraiki version of Activities-specific Balance Confidence Scale
Time frame: 1 week
The ABC scale is a 16-item questionnaire with 11-point subscales that assess the level of confidence in performing a specific task without losing balance or becoming unsteady. Each item score ranges from 0% (no confidence) to 100% (total confidence) and the total score of the S-ABC is obtained by adding up the ratings (0-160) and then dividing by 16
Twelve Item Short Form Health Survey (SF-12)
Time frame: 1 week
The 12-item Short Form Health Survey (SF-12) is a multipurpose, generic, 12-item questionnaire developed from the Short Form Health Survey 36 (SF-36). The SF-12 generates a Physical Component Summary scale score (PCS-SF12) and a Mental Component Summary scale score (MCS-SF12). Several studies have reported its validity and reliability as a measure of health-related quality of life in different populations.
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 17 Jan 2023.
- Individual participant dataSharing planned: No
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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.
Mirza Obaid Baig, MSPT(NMR) principal investigator
Riphah International University
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 Old Age; Debility, run by Riphah International University at 1 site in Pakistan.
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 5 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 17 Jan 2023. 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 Pakistan. 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?
Saraiki version of Activities-specific Balance Confidence Scale (time frame: 1 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Jan 2023.