Activity, MotorNCT05449223
Urdu Version of Frenchay Activities Index: Reliability and Validity Study
An observational study of Activity, Motor, run by Riphah International University at 1 site in Pakistan.
Trial summary
In this study, we will observe the reliability and validity of frenchay activities index and barthel index in urdu language in geriatric population of Pakistan. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Activity, Motor
- How many people
- 75 participants
- Where
- 1 sitePakistan
- Study dates
- 30 Mar 2021to 28 Jul 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 65 years and older
- All sexes
- Older adult
Study population: Elderly people, especially those of the advanced ages having issue in performing in activities of daily living
Who may be able to join
- 65 years old and older
- be able to read Urdu
- be living in Pakistan for more than 5 years
- have minimal cognitive impairment with Mini-Mental State Examination
- have no significant muscle, joint, or neurologic conditions such as stroke, or Parkinson's disease.
Who cannot join
- inability to understand to follow the instructions of Frenchay Activities Index and Barthel Index
- experience with the Frenchay Activities Index and Bathel Index in the last 6 months
- acute illness or fracture in the lower extremities
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Riphah International University
Faisalābad, Punjab Province, 38000
About this study
Official title: Evaluation of Reliability and Validity of Urdu Version of the Frenchay Activities Index in Pakistani Geriatric Population
In this study, we will observe the reliability and validity of frenchay activities index and barthel index in urdu language in geriatric population of Pakistan.
Read the detailed description
The aim of study is to translate and culturally adapt Frenchay Activities Index and Bathel Index into Urdu language and secondly to investigate the reliability and validity of Frenchay Activities Index and Barthel Index in geriatric population of Pakistan. This study will be cross sectional survey study in which convenience sampling technique will be used.
The results of study will help to know the validity and reliability of Frenchay Activities Index and Barthel Index in Urdu version with Activities of Daily Livings impairments in geriatric population of Pakistan. The reliability of the questionnaire will be checked through internal consistency and test-retest methods. internal consistency will be analyzed with Cronbach's alpha value. Test-retest reliability will be assessed using an intra-class correlation coefficient with 75 patients.
- Conditions
- Activity, Motor
- Keywords
- Frenchay Activities Index, Urdu Version, Activities of Daily Living, Validity, Reliability
- Medical subject headings
- Motor Activity
What is being measured
The primary outcome is the main question the study is designed to answer.
Frenchay activities index
Frenchay Activities Index is used to measure performance in activities of daily living. It contains 15 items on common daily activities such as preparing a meal, washing the dishes, housekeeping, shopping, hobbies, going out, and work. The patient is asked whether or not he/she did the activities for the past 3-6 months. The scores are from 1 (never) to 4 (normal frequency) with a total score range from 15 to 60. A lower score means a lower level of functioning.
Measured: 12th Week
Barthel Index
Barthel Index is used to measure performance in activities of daily living. The Barthel Index contains 10 items on sphincter control, grooming, toilet use, eating, transfer, and mobility compromising one dimension on the need for help. The score differs per item and the total score ranges from 0 (totally dependent) to 20 (independent).
Measured: 12th Week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2022
- Study start30 Mar 2021
- Primary completion27 Jul 2022
- Study completion28 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Activity, MotorStudies 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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muhammed Kashif, Study chair, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05449223
- Sponsor's protocol ID
- REC-FSD-00241
- Status last verified
- Jan 2023
- First submitted
- 4 Jul 2022
- 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
- Evaluation of Reliability and Validity of Urdu Version of the Frenchay Activities Index in Pakistani Geriatric Population
- ClinicalTrials.gov ID
- NCT05449223
- Acronym / sponsor ID
- REC-FSD-00241
- Conditions
- Activity, Motor
- Keywords
- Frenchay Activities Index, Urdu Version, Activities of Daily Living, Validity, Reliability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 30 Mar 2021 (actual)
- Primary completion
- 27 Jul 2022 (actual)
- Study completion
- 28 Jul 2022 (actual)
- First posted
- 8 Jul 2022 (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.
In this study, we will observe the reliability and validity of frenchay activities index and barthel index in urdu language in geriatric population of Pakistan.
Detailed description
The aim of study is to translate and culturally adapt Frenchay Activities Index and Bathel Index into Urdu language and secondly to investigate the reliability and validity of Frenchay Activities Index and Barthel Index in geriatric population of Pakistan. This study will be cross sectional survey study in which convenience sampling technique will be used.
The results of study will help to know the validity and reliability of Frenchay Activities Index and Barthel Index in Urdu version with Activities of Daily Livings impairments in geriatric population of Pakistan. The reliability of the questionnaire will be checked through internal consistency and test-retest methods. internal consistency will be analyzed with Cronbach's alpha value. Test-retest reliability will be assessed using an intra-class correlation coefficient with 75 patients.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Age groups
- Older adult
- Study population
- Elderly people, especially those of the advanced ages having issue in performing in activities of daily living
Key inclusion criteria (5 listed)
- 65 years old and older
- be able to read Urdu
- be living in Pakistan for more than 5 years
- have minimal cognitive impairment with Mini-Mental State Examination
- have no significant muscle, joint, or neurologic conditions such as stroke, or Parkinson's disease.
Key exclusion criteria (3 listed)
- inability to understand to follow the instructions of Frenchay Activities Index and Barthel Index
- experience with the Frenchay Activities Index and Bathel Index in the last 6 months
- acute illness or fracture in the lower extremities
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
Frenchay activities index
Time frame: 12th Week
Frenchay Activities Index is used to measure performance in activities of daily living. It contains 15 items on common daily activities such as preparing a meal, washing the dishes, housekeeping, shopping, hobbies, going out, and work. The patient is asked whether or not he/she did the activities for the past 3-6 months. The scores are from 1 (never) to 4 (normal frequency) with a total score range from 15 to 60. A lower score means a lower level of functioning.
Barthel Index
Time frame: 12th Week
Barthel Index is used to measure performance in activities of daily living. The Barthel Index contains 10 items on sphincter control, grooming, toilet use, eating, transfer, and mobility compromising one dimension on the need for help. The score differs per item and the total score ranges from 0 (totally dependent) to 20 (independent).
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.
Muhammed Kashif study chair
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 Activity, Motor, 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?
Frenchay activities index (time frame: 12th 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.