StrokeNCT04728997
Mobility Assessment in Stroke Patients
An observational study of Stroke, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Stroke ranks 3rd among disability-causing diseases worldwide. Following a stroke, loss of lower extremity motor function causes serious gait disturbances. The walking activity is the basis for daily and social engagement activities. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- How many people
- 75 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Apr 2019to Oct 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
- No healthy volunteers
- Adult, Older adult
Study population: The sample of the study will be composed of literate individuals who applied to Ankara Hacettepe University Faculty of Physical Therapy and Rehabilitation, Physiotherapy and Rehabilitation Department and were diagnosed with stroke. The number of cases in the study will be determined as 5 to 10 times the number of items in the questionnaire, and 65-130 individuals will be included.
Who may be able to join
- having a definite stroke and have passed 2 months post-stroke
- individuals who can walk 10 meters without support
- Those whose systemic findings are stable after stroke
- Mini-mental test score of 24 and above
Who cannot join
- Those with musculoskeletal system problems that will affect the individual in terms of mobility
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reliability and Validity of the Turkish Version of the Abiloco
Stroke ranks 3rd among disability-causing diseases worldwide. Following a stroke, loss of lower extremity motor function causes serious gait disturbances. The walking activity is the basis for daily and social engagement activities. Mobility (locomotion) ability; gait analysis can be evaluated with tests and reports examining walking performance. ABILOCO is also a questionnaire developed by Caty et al., evaluating mobility and locomotion in individuals after stroke. The aim of this study is; To investigate the validity and reliability of the Turkish version of the ABILOCO questionnaire developed to evaluate mobility in patients with stroke. The sample of the study will be literate individuals who have had a stroke who applied to the Neurology Unit of Ankara Hacettepe University Faculty of Physical Medicine and Rehabilitation.
Demographic information of the cases will be recorded. ABILOCO questionnaire will be adapted to Turkish. The validity and reliability comparison of the ABILOCO questionnaire with the Berg Balance Scale and Timed Get Up and Go Test will be performed.
Read the detailed description
The sample of the study will consist of literate individuals who applied to Ankara Hacettepe University Faculty of Physical Medicine and Rehabilitation, Physiotherapy and Rehabilitation Department and were diagnosed with stroke. The number of cases in the study will be determined as 5 to 10 times the number of items in the questionnaire, and 65-130 individuals will be included.
Inclusion Criteria:
- Having a definite stroke diagnosis
- Those who have stable post-stroke systemic findings
- Mini-mental test score of 24 and above
- Those who can walk 10 meters unsupported
- Those who passed 2 months after stroke.
Criteria for exclusion from the study:
- Having musculoskeletal problems that affect the mobility of the individual.
The study will use ABILOCO, which has been validated for individuals with stroke. Permission was obtained from Gilles D. Caty, the development of the questionnaire, to conduct translation and validity and cultural adaptation stduies into Turkish. In the study, firstly, the original English version of the questionnaire will be translated into Turkish by two professional translators independent of the study, and then it will be translated back into its original language English by two native English speakers who do not have a medical background. Translators will be brought together to discuss the two obtained versions of the questionnaire. The latest version of the questionnaire will be translated into the native language of the inventory and its compliance will be checked. Mini-Mental Test will be applied to determine the cognitive status of the participants. Berg Balance Scale and Timed Get Up and Go Test will be applied for mobility assessment. After that, the ABILOCO questionnaire will be applied to the participants. In order to test the reliability of the survey, the survey will be repeated 7 days later. Informed consent will be obtained from each participant regarding their voluntary participation in the study and their sociodemographic information will be recorded.
- Conditions
- Stroke
- Keywords
- stroke, questionnaire, ABILOCO
- Medical subject headings
- Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
ABILOCO Questionnaire
Turkish version of ABILOCO questionnaire evaluation of validity and reliability in stroke patients ABILOCO: A questionnaire evaluating mobility
Measured: baseline
Secondary outcomes (2)
Berg Balance Scale
Berg Balance Scale: An assessment evaluating balance and risk of falling
Measured: baseline
Time up and Go test
Time up and Go: A test evaluating mobility (locomotion), requires static and dynamic balance
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2021
- Study start3 Apr 2019
- Primary completionJun 2021 (estimated)
- Study completionOct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Hacettepe 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-control
- Time perspective
- Prospective
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esra Keski̇n, Hacettepe University
- Investigators
- ESRA KESKİN, Principal investigator, Study Principal İnvestigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04728997
- Sponsor's protocol ID
- EKeskin
- Status last verified
- Jan 2021
- First submitted
- 25 Jan 2021
- Last updated
- 28 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability and Validity of the Turkish Version of the Abiloco
- ClinicalTrials.gov ID
- NCT04728997
- Acronym / sponsor ID
- EKeskin
- Conditions
- Stroke
- Keywords
- stroke, questionnaire, ABILOCO
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 3 Apr 2019 (actual)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Oct 2021 (estimated)
- First posted
- 28 Jan 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.
Stroke ranks 3rd among disability-causing diseases worldwide. Following a stroke, loss of lower extremity motor function causes serious gait disturbances. The walking activity is the basis for daily and social engagement activities. Mobility (locomotion) ability; gait analysis can be evaluated with tests and reports examining walking performance. ABILOCO is also a questionnaire developed by Caty et al., evaluating mobility and locomotion in individuals after stroke. The aim of this study is; To investigate the validity and reliability of the Turkish version of the ABILOCO questionnaire developed to evaluate mobility in patients with stroke. The sample of the study will be literate individuals who have had a stroke who applied to the Neurology Unit of Ankara Hacettepe University Faculty of Physical Medicine and Rehabilitation.
Demographic information of the cases will be recorded. ABILOCO questionnaire will be adapted to Turkish. The validity and reliability comparison of the ABILOCO questionnaire with the Berg Balance Scale and Timed Get Up and Go Test will be performed.
Detailed description
The sample of the study will consist of literate individuals who applied to Ankara Hacettepe University Faculty of Physical Medicine and Rehabilitation, Physiotherapy and Rehabilitation Department and were diagnosed with stroke. The number of cases in the study will be determined as 5 to 10 times the number of items in the questionnaire, and 65-130 individuals will be included.
Inclusion Criteria:
- Having a definite stroke diagnosis
- Those who have stable post-stroke systemic findings
- Mini-mental test score of 24 and above
- Those who can walk 10 meters unsupported
- Those who passed 2 months after stroke.
Criteria for exclusion from the study:
- Having musculoskeletal problems that affect the mobility of the individual.
The study will use ABILOCO, which has been validated for individuals with stroke. Permission was obtained from Gilles D. Caty, the development of the questionnaire, to conduct translation and validity and cultural adaptation stduies into Turkish. In the study, firstly, the original English version of the questionnaire will be translated into Turkish by two professional translators independent of the study, and then it will be translated back into its original language English by two native English speakers who do not have a medical background. Translators will be brought together to discuss the two obtained versions of the questionnaire. The latest version of the questionnaire will be translated into the native language of the inventory and its compliance will be checked. Mini-Mental Test will be applied to determine the cognitive status of the participants. Berg Balance Scale and Timed Get Up and Go Test will be applied for mobility assessment. After that, the ABILOCO questionnaire will be applied to the participants. In order to test the reliability of the survey, the survey will be repeated 7 days later. Informed consent will be obtained from each participant regarding their voluntary participation in the study and their sociodemographic information will be recorded.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The sample of the study will be composed of literate individuals who applied to Ankara Hacettepe University Faculty of Physical Therapy and Rehabilitation, Physiotherapy and Rehabilitation Department and were diagnosed with stroke. The number of cases in the study will be determined as 5 to 10 times the number of items in the questionnaire, and 65-130 individuals will be included.
Key inclusion criteria (4 listed)
- having a definite stroke and have passed 2 months post-stroke
- individuals who can walk 10 meters without support
- Those whose systemic findings are stable after stroke
- Mini-mental test score of 24 and above
Key exclusion criteria (1 listed)
- Those with musculoskeletal system problems that will affect the individual in terms of mobility
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
ABILOCO Questionnaire
Time frame: baseline
Turkish version of ABILOCO questionnaire evaluation of validity and reliability in stroke patients ABILOCO: A questionnaire evaluating mobility
2 secondary outcomes
Berg Balance Scale
Time frame: baseline
Time up and Go test
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Stroke
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The AHA Oneida Study
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Acute Ischemic Stroke
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Left Atrial Appendage Exclusion for Prophylactic Stroke Reduction Trial
Ischemic Stroke, Systemic Embolism
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A Study of Orforglipron (LY3502970) on Cardiovascular Outcomes in Adults With Atherosclerotic Cardiovascular Disease and/or Chronic Kidney Disease (ATTAIN-Outcomes)
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Active, not recruiting
Brain Connectivity Analysis
Neural Injury
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.
ESRA KESKİN principal investigator
Study Principal İnvestigator
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 Stroke, run by Hacettepe 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 4 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 28 Jan 2021. 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?
Results are not available in the source record.
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?
ABILOCO Questionnaire (time frame: baseline). 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 28 Jan 2021.