Hip FractureNCT02512094
Validity and Reliability of Thai Version of Barthel Index for Hip Fracture Patients
An observational study of Hip Fracture and Femoral Neck Fracture, run by Mahidol University at 1 site in Thailand.
Trial summary
Since an increasing in population age, there was an increasing in geriatric patients. Most of elderly patients needed rehabilitation programs to regain their quality of life during their medical treatments. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Hip Fracture, Femoral Neck Fracture, Intertrochanteric Fracture
- How many people
- 53 participants
- Where
- 1 siteThailand
- Study dates
- Jun 2014to Jun 2016
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hip fractured patients
Who may be able to join
- Age at least 50 years old
- Hip fractures within 2 weeks since injury
Who cannot join
- incommunicable patients
- pathological fractures
- multiple fractures or multiple trauma
- postoperative complications which change postoperative rehabilitation protocols
Trial locations and contacts
1 site in 1 country.
About this study
Since an increasing in population age, there was an increasing in geriatric patients. Most of elderly patients needed rehabilitation programs to regain their quality of life during their medical treatments. Barthel index is a functional measurement to evaluate rehabilitation improvement in chronically-ill patients and also used for evaluation of patient's self-care.
Barthel index had been translated into many languages and validated in many medical conditions such as spinal cord injury, congestive heart failure, pneumonia, etc. However, Barthel index had not been translated into Thai language and validated to use in hip fracture patients.
The purposes of this study were to translate the Barthel index into Thai language and to assess validity and reliability of Thai version Barthel index in hip fracture patients.
Read the detailed description
Since an increasing in population age, there was an increasing in geriatric patients. Most of elderly patients needed rehabilitation programs to regain their quality of life during their medical treatments. Barthel index is a functional measurement to evaluate rehabilitation improvement in chronically-ill patients and also used for evaluation of patient's self-care. This index had initially developed to evaluate the self-care of stroke patients which comprised of 10 questions about their basic activity of daily living. Barthel index had been well-accepted and widely used. Barthel index had been translated into many languages and validated in many medical conditions such as spinal cord injury, congestive heart failure, pneumonia, etc. However, Barthel index had not been translated into Thai language and validated to use in hip fracture patients.
Hip fractures was usually occured in geriatric patients and there was a trend to increase every year. Most of the hip fractures were treated by surgical methods which needed postoperative rehabilitation programs to regain their functions. Less than half of the patients with hip fracture could regain their functions to preoperative level. Therefore, these patients needed a specific questionnaire to evaluate their functions. Barthel index is an uncomplicated questionnaire and can be used to evaluate treatment outcome of the patients.
The purposes of this study were to translate the Barthel index into Thai language and to assess validity and reliability of Thai version Barthel index in hip fracture patients.
- Keywords
- Barthel index, Hip fracture, Validity, Reliability
- Medical subject headings
- Hip Fractures, Femoral Neck Fractures
What is being measured
The primary outcome is the main question the study is designed to answer.
Score of the Barthel Index
Score of the Barthel Index ranging from 0 to 100 were collected when 0 is the minimum (worst outcome) and 100 is the maximum (best outcome).
Score was reported as mean score of the Barthel Index.
Measured: up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2015 (estimated)
- Study startJun 2014
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hip FractureStudies of the same condition, open and under way.
- More trials run by Mahidol 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aasis Unnanuntana, M.D., Principal investigator, Siriraj Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02512094
- Sponsor's protocol ID
- 236/2557(EC3)
- Status last verified
- Feb 2018
- First submitted
- 26 Jul 2015
- Last updated
- 22 Feb 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity and Reliability of Thai Version of Barthel Index for Hip Fracture Patients
- ClinicalTrials.gov ID
- NCT02512094
- Acronym / sponsor ID
- 236/2557(EC3)
- Keywords
- Barthel index, Hip fracture, Validity, Reliability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 30 Jul 2015 (estimated)
- Results
- Posted 22 Feb 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Since an increasing in population age, there was an increasing in geriatric patients. Most of elderly patients needed rehabilitation programs to regain their quality of life during their medical treatments. Barthel index is a functional measurement to evaluate rehabilitation improvement in chronically-ill patients and also used for evaluation of patient's self-care.
Barthel index had been translated into many languages and validated in many medical conditions such as spinal cord injury, congestive heart failure, pneumonia, etc. However, Barthel index had not been translated into Thai language and validated to use in hip fracture patients.
The purposes of this study were to translate the Barthel index into Thai language and to assess validity and reliability of Thai version Barthel index in hip fracture patients.
Detailed description
Since an increasing in population age, there was an increasing in geriatric patients. Most of elderly patients needed rehabilitation programs to regain their quality of life during their medical treatments. Barthel index is a functional measurement to evaluate rehabilitation improvement in chronically-ill patients and also used for evaluation of patient's self-care. This index had initially developed to evaluate the self-care of stroke patients which comprised of 10 questions about their basic activity of daily living. Barthel index had been well-accepted and widely used. Barthel index had been translated into many languages and validated in many medical conditions such as spinal cord injury, congestive heart failure, pneumonia, etc. However, Barthel index had not been translated into Thai language and validated to use in hip fracture patients.
Hip fractures was usually occured in geriatric patients and there was a trend to increase every year. Most of the hip fractures were treated by surgical methods which needed postoperative rehabilitation programs to regain their functions. Less than half of the patients with hip fracture could regain their functions to preoperative level. Therefore, these patients needed a specific questionnaire to evaluate their functions. Barthel index is an uncomplicated questionnaire and can be used to evaluate treatment outcome of the patients.
The purposes of this study were to translate the Barthel index into Thai language and to assess validity and reliability of Thai version Barthel index in hip fracture patients.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hip fractured patients
Key inclusion criteria (2 listed)
- Age at least 50 years old
- Hip fractures within 2 weeks since injury
Key exclusion criteria (4 listed)
- incommunicable patients
- pathological fractures
- multiple fractures or multiple trauma
- postoperative complications which change postoperative rehabilitation protocols
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
Score of the Barthel Index
Time frame: up to 1 month
Score of the Barthel Index ranging from 0 to 100 were collected when 0 is the minimum (worst outcome) and 100 is the maximum (best outcome). Score was reported as mean score of the Barthel Index.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Aasis Unnanuntana, M.D. principal investigator
Siriraj Hospital
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 Hip Fracture and Femoral Neck Fracture, run by Mahidol University at 1 site in Thailand.
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 2 inclusion and 4 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 22 Feb 2018. 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 Thailand. 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?
Yes. Results are posted in the registry (first posted 22 Feb 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Score of the Barthel Index (time frame: up to 1 month). 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 22 Feb 2018.